Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults

• ClinicalTrials.gov Identifier: NCT03049488
• Recruitment Status: Completed
• First Posted: February 10, 2017
• Results First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus
• Interventions: Biological: VRC-RSVRGP084-00-VP; Other: Aluminum Hydroxide Suspension
• Enrollment: 95

Participant Flow

Recruitment Details	Healthy adults were recruited from the Washington, D.C., metropolitan area.
Pre-assignment Details

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Period Title: Overall Study
Started	15	15	20	15	15	15
Received First Product Administration	15	15	20	15	15	15
Received Optional Second Dose	10	11	11	9	11	10
Completed	13	13	20	13	13	15
Not Completed	2	2	0	2	2	0
Reason Not Completed
Lost to Follow-up	1	1	0	0	0	0
Moved from Area	1	0	0	1	1	0
Physician Decision	0	1	0	0	0	0
Withdrawal by Subject	0	0	0	1	1	0

Baseline Characteristics

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum	Total
Arm/Group Description		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	Total of all reporting groups
Overall Number of Baseline Participants		15	15	20	15	15	15	95
Baseline Analysis Population Description		Population includes all enrolled subjects.
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	15 participants	15 participants	20 participants	15 participants	15 participants	15 participants	95 participants
18-20 years		0 0.0%	2 13.3%	1 5.0%	1 6.7%	0 0.0%	0 0.0%	4 4.2%
21-30 years		4 26.7%	4 26.7%	9 45.0%	6 40.0%	8 53.3%	11 73.3%	42 44.2%
31-40 years		9 60.0%	5 33.3%	6 30.0%	6 40.0%	4 26.7%	3 20.0%	33 34.7%
41-50 years		2 13.3%	4 26.7%	4 20.0%	2 13.3%	3 20.0%	1 6.7%	16 16.8%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	15 participants	20 participants	15 participants	15 participants	15 participants	95 participants
	Female	9 60.0%	6 40.0%	9 45.0%	8 53.3%	9 60.0%	8 53.3%	49 51.6%
	Male	6 40.0%	9 60.0%	11 55.0%	7 46.7%	6 40.0%	7 46.7%	46 48.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	15 participants	15 participants	20 participants	15 participants	15 participants	15 participants	95 participants
Asian		4 26.7%	1 6.7%	4 20.0%	0 0.0%	3 20.0%	3 20.0%	15 15.8%
Black or African American		1 6.7%	3 20.0%	1 5.0%	4 26.7%	0 0.0%	0 0.0%	9 9.5%
White		10 66.7%	11 73.3%	13 65.0%	9 60.0%	12 80.0%	10 66.7%	65 68.4%
Multiracial		0 0.0%	0 0.0%	2 10.0%	2 13.3%	0 0.0%	2 13.3%	6 6.3%
Hispanic/Latino		0 0.0%	1 6.7%	2 10.0%	0 0.0%	4 26.7%	1 6.7%	8 8.4%
Body Mass Index (BMI); Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	15 participants	15 participants	20 participants	15 participants	15 participants	15 participants	95 participants
18.5-24.9 kg/m^2		5 33.3%	6 40.0%	8 40.0%	5 33.3%	7 46.7%	8 53.3%	39 41.1%
25.0-29.9 kg/m^2		8 53.3%	3 20.0%	9 45.0%	7 46.7%	7 46.7%	5 33.3%	39 41.1%
30.0 kg/m^2 or over		2 13.3%	6 40.0%	3 15.0%	3 20.0%	1 6.7%	2 13.3%	17 17.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after the first product administration (Day 7)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed		15	15	20	15	15	15
Measure Type: Count of Participants; Unit of Measure: Participants
Pain/Tenderness	None	6 40.0%	5 33.3%	11 55.0%	8 53.3%	7 46.7%	6 40.0%
	Mild	9 60.0%	10 66.7%	9 45.0%	7 46.7%	8 53.3%	9 60.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Swelling	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	15 100.0%	14 93.3%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Redness	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	15 100.0%	15 100.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Local Symptom	None	6 40.0%	5 33.3%	11 55.0%	8 53.3%	7 46.7%	6 40.0%
	Mild	9 60.0%	10 66.7%	9 45.0%	7 46.7%	8 53.3%	9 60.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

2. Primary Outcome

Title	Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after the second product administration (Day 91)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed		10	11	11	9	11	10
Measure Type: Count of Participants; Unit of Measure: Participants
Pain/Tenderness	None	3 30.0%	6 54.5%	6 54.5%	4 44.4%	2 18.2%	3 30.0%
	Mild	7 70.0%	5 45.5%	5 45.5%	5 55.6%	8 72.7%	7 70.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Swelling	None	10 100.0%	11 100.0%	11 100.0%	9 100.0%	11 100.0%	10 100.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Redness	None	10 100.0%	11 100.0%	11 100.0%	9 100.0%	11 100.0%	10 100.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Local Symptom	None	3 30.0%	6 54.5%	6 54.5%	4 44.4%	2 18.2%	3 30.0%
	Mild	7 70.0%	5 45.5%	5 45.5%	5 55.6%	8 72.7%	7 70.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

3. Primary Outcome

Title	Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after each product administration

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum	All DS-Cav1 Dose Groups
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed		15	15	20	15	15	15	95
Measure Type: Count of Participants; Unit of Measure: Participants
Pain/Tenderness	None	4 26.7%	5 33.3%	8 40.0%	3 20.0%	4 26.7%	3 20.0%	27 28.4%
	Mild	11 73.3%	10 66.7%	12 60.0%	12 80.0%	10 66.7%	12 80.0%	67 70.5%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 1.1%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Swelling	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	15 100.0%	14 93.3%	94 98.9%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	1 1.1%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Redness	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	15 100.0%	15 100.0%	95 100.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Local Symptom	None	4 26.7%	5 33.3%	8 40.0%	3 20.0%	4 26.7%	3 20.0%	27 28.4%
	Mild	11 73.3%	10 66.7%	12 60.0%	12 80.0%	10 66.7%	12 80.0%	67 70.5%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 1.1%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

4. Primary Outcome

Title	Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the first study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after the first product administration (Day 7)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed		15	15	20	15	15	15
Measure Type: Count of Participants; Unit of Measure: Participants
Malaise	None	13 86.7%	13 86.7%	17 85.0%	12 80.0%	11 73.3%	11 73.3%
	Mild	2 13.3%	2 13.3%	3 15.0%	3 20.0%	4 26.7%	4 26.7%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Myalgia	None	15 100.0%	13 86.7%	19 95.0%	9 60.0%	12 80.0%	13 86.7%
	Mild	0 0.0%	2 13.3%	1 5.0%	6 40.0%	3 20.0%	2 13.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Headache	None	13 86.7%	11 73.3%	18 90.0%	10 66.7%	13 86.7%	10 66.7%
	Mild	2 13.3%	4 26.7%	2 10.0%	5 33.3%	2 13.3%	5 33.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Chills	None	14 93.3%	15 100.0%	20 100.0%	14 93.3%	13 86.7%	13 86.7%
	Mild	1 6.7%	0 0.0%	0 0.0%	1 6.7%	2 13.3%	2 13.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Nausea	None	14 93.3%	14 93.3%	19 95.0%	15 100.0%	14 93.3%	14 93.3%
	Mild	1 6.7%	1 6.7%	1 5.0%	0 0.0%	1 6.7%	1 6.7%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Temperature	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	14 93.3%	15 100.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Systemic Symptom	None	12 80.0%	11 73.3%	15 75.0%	9 60.0%	10 66.7%	9 60.0%
	Mild	3 20.0%	4 26.7%	5 25.0%	6 40.0%	5 33.3%	6 40.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

5. Primary Outcome

Title	Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the second study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after the second product administration (Day 91)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=62).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed		10	11	11	9	11	10
Measure Type: Count of Participants; Unit of Measure: Participants
Malaise	None	9 90.0%	9 81.8%	11 100.0%	8 88.9%	8 72.7%	9 90.0%
	Mild	0 0.0%	2 18.2%	0 0.0%	1 11.1%	3 27.3%	1 10.0%
	Moderate	1 10.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Myalgia	None	9 90.0%	10 90.9%	9 81.8%	8 88.9%	10 90.9%	7 70.0%
	Mild	1 10.0%	1 9.1%	2 18.2%	1 11.1%	1 9.1%	3 30.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Headache	None	8 80.0%	10 90.9%	10 90.9%	8 88.9%	8 72.7%	9 90.0%
	Mild	2 20.0%	1 9.1%	1 9.1%	1 11.1%	2 18.2%	1 10.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Chills	None	10 100.0%	11 100.0%	11 100.0%	9 100.0%	11 100.0%	9 90.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 10.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Nausea	None	10 100.0%	11 100.0%	11 100.0%	9 100.0%	11 100.0%	9 90.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 10.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Temperature	None	10 100.0%	11 100.0%	11 100.0%	9 100.0%	11 100.0%	9 90.0%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 10.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Systemic Symptom	None	7 70.0%	9 81.8%	9 81.8%	7 77.8%	7 63.6%	6 60.0%
	Mild	2 20.0%	2 18.2%	2 18.2%	2 22.2%	3 27.3%	4 40.0%
	Moderate	1 10.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

6. Primary Outcome

Title	Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Time Frame	7 days after each product administration

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title		Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum	All DS-Cav1 Dose Groups
Arm/Group Description:		DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed		15	15	20	15	15	15	95
Measure Type: Count of Participants; Unit of Measure: Participants
Malaise	None	12 80.0%	11 73.3%	17 85.0%	12 80.0%	9 60.0%	11 73.3%	72 75.8%
	Mild	2 13.3%	4 26.7%	3 15.0%	3 20.0%	6 40.0%	4 26.7%	22 23.2%
	Moderate	1 6.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 1.1%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Myalgia	None	14 93.3%	12 80.0%	17 85.0%	9 60.0%	12 80.0%	12 80.0%	76 80.0%
	Mild	1 6.7%	3 20.0%	3 15.0%	6 40.0%	3 20.0%	3 20.0%	19 20.0%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Headache	None	12 80.0%	10 66.7%	17 85.0%	9 60.0%	11 73.3%	10 66.7%	69 72.6%
	Mild	3 20.0%	5 33.3%	3 15.0%	6 40.0%	3 20.0%	5 33.3%	25 26.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 1.1%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Chills	None	14 93.3%	15 100.0%	20 100.0%	14 93.3%	13 86.7%	13 86.7%	89 93.7%
	Mild	1 6.7%	0 0.0%	0 0.0%	1 6.7%	2 13.3%	2 13.3%	6 6.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Nausea	None	14 93.3%	14 93.3%	19 95.0%	15 100.0%	14 93.3%	13 86.7%	89 93.7%
	Mild	1 6.7%	1 6.7%	1 5.0%	0 0.0%	1 6.7%	2 13.3%	6 6.3%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Temperature	None	15 100.0%	15 100.0%	20 100.0%	15 100.0%	14 93.3%	14 93.3%	93 97.9%
	Mild	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	1 6.7%	2 2.1%
	Moderate	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Any Systemic Symptom	None	10 66.7%	10 66.7%	13 65.0%	8 53.3%	8 53.3%	7 46.7%	56 58.9%
	Mild	4 26.7%	5 33.3%	7 35.0%	7 46.7%	6 40.0%	8 53.3%	37 38.9%
	Moderate	1 6.7%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	2 2.1%
	Severe	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

7. Primary Outcome

Title	Number of Subjects With Abnormal Laboratory Measures of Safety
Description	Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, white blood cell (WBC) and red blood cell (RBC) counts, and neutrophil, lymphocyte, monocyte, eosinophil and basophil percents and counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) differential, platelet, creatinine and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 7, 28, 84, 91 and 112. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Time Frame	Day 0 through Day 308

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who had laboratory results available at any study visit post baseline.

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum	All DS-Cav1 Dose Groups
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 dose groups included adults who received up to two doses of either DS-Cav1 (50 mcg) alone, DS-Cav1 (50 mcg) + alum, DS-Cav1 (150 mcg) alone, DS-Cav1 (150 mcg) + alum, DS-Cav1 (500 mcg) alone, or DS-Cav1 (500 mcg) + alum 12 weeks apart.
Overall Number of Participants Analyzed	15	15	20	15	15	15	95
Measure Type: Count of Participants; Unit of Measure: Participants
ALT	0 0.0%	1 6.7%	1 5.0%	1 6.7%	0 0.0%	0 0.0%	3 3.2%
Creatinine	0 0.0%	1 6.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 1.1%
WBC Count	1 6.7%	0 0.0%	0 0.0%	1 6.7%	1 6.7%	0 0.0%	3 3.2%
Hemoglobin	3 20.0%	0 0.0%	1 5.0%	1 6.7%	4 26.7%	1 6.7%	10 10.5%
Neutrophil Count	0 0.0%	2 13.3%	1 5.0%	0 0.0%	2 13.3%	1 6.7%	6 6.3%
Lymphocyte Count	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 1.1%
Eosinophil Count	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.7%	0 0.0%	1 1.1%

8. Primary Outcome

Title	Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs)
Description	Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 28 days after each study product administration. At other time periods between study product administrations and when greater than 28 days after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame	Day 0 through Day 28 after product administration

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed	15	15	20	15	15	15
Measure Type: Count of Participants; Unit of Measure: Participants
Related to Study Product	3 20.0%	3 20.0%	2 10.0%	0 0.0%	4 26.7%	3 20.0%
Unrelated to Study Product	3 20.0%	7 46.7%	12 60.0%	7 46.7%	7 46.7%	6 40.0%

9. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	SAEs were reported from receipt of first study product administration through the last expected study visit at Day 308. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Time Frame	Day 0 through Day 308

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant and provided safety data (via diary card and/or laboratory results) following the injection (N=95).

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed	15	15	20	15	15	15
Measure Type: Count of Participants; Unit of Measure: Participants
Related to Study Product	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Unrelated to Study Product	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

10. Primary Outcome

Title	Number of Subjects Who Had Respiratory Syncytial Virus (RSV) Infection Following Product Administration
Description	Respiratory Syncytial Virus (RSV) cases were recorded in the study database from receipt of the first study product administration through the last study visit.
Time Frame	Day 0 through Day 308

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed	15	15	20	15	15	15
Measure Type: Count of Participants; Unit of Measure: Participants
	1 6.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

11. Secondary Outcome

Title	Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the First Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time Frame	4 weeks after the first product administration (Week 4)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received at least one study injection of DS-Cav1 alone or with alum adjuvant (N=95).

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed	15	15	20	15	15	15
Geometric Mean (Full Range); Unit of Measure: titer
Week 0 (Baseline, Pre-Administration)	777; (192 to 3167)	689; (288 to 2141)	736; (216 to 4676)	653; (186 to 2476)	707; (230 to 5725)	669; (321 to 1840)
Week 4	4203; (1001 to 10910)	3486; (1385 to 18852)	5422; (2050 to 13104)	5513; (1715 to 17602)	7495; (2370 to 16870)	6083; (2301 to 13522)

12. Secondary Outcome

Title	Respiratory Syncytial Virus Subtype A (RSV A) Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Second Product Administration of DS-Cav1 Alone or With Alum Adjuvant
Description	Neutralizing antibody titers were determined against a reporter RSV A2 virus (RSV A), and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. Measurements were normalized to international units per milliliter.
Time Frame	4 weeks after the second product administration (Week 16)

Outcome Measure Data

Analysis Population Description

Population included all enrolled subjects who received the optional second study injection of DS-Cav1 alone or with alum adjuvant (N=62).

Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description:	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
Overall Number of Participants Analyzed	10	11	11	9	11	10
Geometric Mean (Full Range); Unit of Measure: titer
Week 0 (Baseline, Pre-Administration)	866; (192 to 3167)	734; (288 to 2141)	790; (498 to 1601)	578; (186 to 1526)	680; (267 to 1300)	839; (486 to 1840)
Week 16	3844; (1108 to 9545)	2536; (1566 to 10771)	4201; (1985 to 9673)	4033; (2235 to 7977)	5193; (2783 to 9251)	4440; (1909 to 10551)

Adverse Events

Time Frame	Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
Adverse Event Reporting Description	Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
Arm/Group Title	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
Arm/Group Description	DS-Cav1 (50 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (50 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (150 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *The Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection, and for 5 additional subjects who were enrolled to evaluate the safety or immunogenicity of a single vaccine dose. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (150 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.	DS-Cav1 (500 mcg) administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.	DS-Cav1 (500 mcg) + alum administered IM by Needle/Syringe (Day 0 and Week 12*) *To evaluate the safety or immunogenicity of a single vaccine dose, the Week 12 dose was optional for the last 5 subjects who enrolled in this group and received the Day 0 injection. VRC-RSVRGP084-00-VP: VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine. Aluminum Hydroxide Suspension: Aluminum Hydroxide Suspension, alum, is an adjuvant.
All-Cause Mortality
	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Serious Adverse Events
	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Group 1: DS-Cav1 (50 mcg)	Group 2: DS-Cav1 (50 mcg) + Alum	Group 3: DS-Cav1 (150 mcg)	Group 4: DS-Cav1 (150 mcg) + Alum	Group 5: DS-Cav1 (500 mcg)	Group 6: DS-Cav1 (500 mcg) + Alum
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/15 (80.00%)	12/15 (80.00%)	20/20 (100.00%)	13/15 (86.67%)	14/15 (93.33%)	12/15 (80.00%)
Blood and lymphatic system disorders
Anaemia * 1	3/15 (20.00%)	0/15 (0.00%)	1/20 (5.00%)	1/15 (6.67%)	4/15 (26.67%)	1/15 (6.67%)
Neutropenia * 1	0/15 (0.00%)	2/15 (13.33%)	1/20 (5.00%)	0/15 (0.00%)	2/15 (13.33%)	1/15 (6.67%)
Eosinophilia * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Leukocytosis * 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Leukopenia * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	1/15 (6.67%)	1/15 (6.67%)	0/15 (0.00%)
Lymphadenopathy * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Lymphopenia * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Cardiac disorders
Bradycardia * 1	0/15 (0.00%)	1/15 (6.67%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Tachycardia * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Gastrointestinal disorders
Abdominal pain * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Diarrhoea * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	1/15 (6.67%)	0/15 (0.00%)	0/15 (0.00%)
Gastritis * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Toothache * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	1/15 (6.67%)
Nausea † 1	1/15 (6.67%)	1/15 (6.67%)	1/20 (5.00%)	0/15 (0.00%)	1/15 (6.67%)	2/15 (13.33%)
General disorders
Administration site pain † 1	11/15 (73.33%)	10/15 (66.67%)	12/20 (60.00%)	12/15 (80.00%)	11/15 (73.33%)	12/15 (80.00%)
Injection site bruising * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Administration site swelling † 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Chills † 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	1/15 (6.67%)	2/15 (13.33%)	2/15 (13.33%)
Malaise † 1	3/15 (20.00%)	4/15 (26.67%)	3/20 (15.00%)	3/15 (20.00%)	6/15 (40.00%)	4/15 (26.67%)
Pyrexia † 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	1/15 (6.67%)
Infections and infestations
Upper Respiratory Tract Infection * 1	2/15 (13.33%)	4/15 (26.67%)	7/20 (35.00%)	2/15 (13.33%)	2/15 (13.33%)	3/15 (20.00%)
Bronchitis * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Sinusitis * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Viral infection * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	1/15 (6.67%)	0/15 (0.00%)	0/15 (0.00%)
Gastroenteritis * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Injury, poisoning and procedural complications
Arthropod bite * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Burns first degree * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Contusion * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Muscle strain * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Investigations
Alanine aminotransferase increased * 1	0/15 (0.00%)	1/15 (6.67%)	1/20 (5.00%)	1/15 (6.67%)	0/15 (0.00%)	0/15 (0.00%)
Blood creatinine increased * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Hepatic enzyme increased * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Musculoskeletal and connective tissue disorders
Muscle spasms * 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	1/15 (6.67%)
Muscle twitching * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Musculoskeletal chest pain * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Musculoskeletal pain * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Osteoarthritis * 1	0/15 (0.00%)	1/15 (6.67%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Myalgia † 1	1/15 (6.67%)	3/15 (20.00%)	3/20 (15.00%)	6/15 (40.00%)	3/15 (20.00%)	3/15 (20.00%)
Nervous system disorders
Dizziness * 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	1/15 (6.67%)
Headache † 1	3/15 (20.00%)	5/15 (33.33%)	3/20 (15.00%)	6/15 (40.00%)	4/15 (26.67%)	5/15 (33.33%)
Presyncope * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Headache * 1	1/15 (6.67%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Psychiatric disorders
Abnormal dreams * 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Anxiety * 1	0/15 (0.00%)	0/15 (0.00%)	1/20 (5.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
Respiratory, thoracic and mediastinal disorders
Laryngeal pain * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	1/15 (6.67%)
Vascular disorders
Hypertension * 1	0/15 (0.00%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	1/15 (6.67%)	0/15 (0.00%)
Hypotension * 1	1/15 (6.67%)	0/15 (0.00%)	0/20 (0.00%)	0/15 (0.00%)	0/15 (0.00%)	0/15 (0.00%)
1 Term from vocabulary, MedDRA 23.0; * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Martin Gaudinski, MD
• Organization: Vaccine Research Center, NIAID, NIH
• Phone: (301) 451-8715
• EMail: martin.gaudinski@nih.gov

Publications:

Ruckwardt TJ, Morabito KM, Graham BS. Determinants of early life immune responses to RSV infection. Curr Opin Virol. 2016 Feb;16:151-157. doi: 10.1016/j.coviro.2016.01.003. Epub 2016 Mar 15.

Ngwuta JO, Chen M, Modjarrad K, Joyce MG, Kanekiyo M, Kumar A, Yassine HM, Moin SM, Killikelly AM, Chuang GY, Druz A, Georgiev IS, Rundlet EJ, Sastry M, Stewart-Jones GB, Yang Y, Zhang B, Nason MC, Capella C, Peeples ME, Ledgerwood JE, McLellan JS, Kwong PD, Graham BS. Prefusion F-specific antibodies determine the magnitude of RSV neutralizing activity in human sera. Sci Transl Med. 2015 Oct 14;7(309):309ra162. doi: 10.1126/scitranslmed.aac4241.

Graham BS, Modjarrad K, McLellan JS. Novel antigens for RSV vaccines. Curr Opin Immunol. 2015 Aug;35:30-8. doi: 10.1016/j.coi.2015.04.005. Epub 2015 Jun 10.

Crank MC, Ruckwardt TJ, Chen M, Morabito KM, Phung E, Costner PJ, Holman LA, Hickman SP, Berkowitz NM, Gordon IJ, Yamshchikov GV, Gaudinski MR, Kumar A, Chang LA, Moin SM, Hill JP, DiPiazza AT, Schwartz RM, Kueltzo L, Cooper JW, Chen P, Stein JA, Carlton K, Gall JG, Nason MC, Kwong PD, Chen GL, Mascola JR, McLellan JS, Ledgerwood JE, Graham BS; VRC 317 Study Team. A proof of concept for structure-based vaccine design targeting RSV in humans. Science. 2019 Aug 2;365(6452):505-509. doi: 10.1126/science.aav9033.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ruckwardt TJ, Morabito KM, Phung E, Crank MC, Costner PJ, Holman LA, Chang LA, Hickman SP, Berkowitz NM, Gordon IJ, Yamshchikov GV, Gaudinski MR, Lin B, Bailer R, Chen M, Ortega-Villa AM, Nguyen T, Kumar A, Schwartz RM, Kueltzo LA, Stein JA, Carlton K, Gall JG, Nason MC, Mascola JR, Chen G, Graham BS; VRC 317 study team. Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation clinical trial. Lancet Respir Med. 2021 Oct;9(10):1111-1120. doi: 10.1016/S2213-2600(21)00098-9. Epub 2021 Apr 14.

• Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
• ClinicalTrials.gov Identifier: NCT03049488
• Other Study ID Numbers: 170058; 17-I-0058 ( Other Identifier: NIH NIAID IRB )
• First Submitted: February 9, 2017
• First Posted: February 10, 2017
• Results First Submitted: September 29, 2020
• Results First Posted: October 23, 2020
• Last Update Posted: October 23, 2020