This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05512949
Recruitment Status : Active, not recruiting
First Posted : August 23, 2022
Results First Posted : January 9, 2024
Last Update Posted : January 9, 2024
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Monkeypox
Intervention Biological: JYNNEOS
Enrollment 229
Recruitment Details Participants were healthy, non-pregnant, non-breastfeeding adults 18 to 50 years old recruited from the communities at large surrounding 8 clinical sites throughout the U.S. The enrollment period occurred between 09SEP2022 and 12OCT2022.
Pre-assignment Details  
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description

0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.

JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10^8 to 3.95 x 10^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.

0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.

JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10^8 to 3.95 x 10^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.

0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.

JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10^8 to 3.95 x 10^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Subcutaneous vaccination is administered in the deltoid region.

Period Title: Overall Study
Started 75 78 76
Completed 69 68 71
Not Completed 6 10 5
Reason Not Completed
Lost to Follow-up             4             6             2
Protocol Violation             0             0             1
Withdrawal by Subject             1             1             2
Completion status unknown             1             3             0
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN Total
Hide Arm/Group Description 0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. 0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. 0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29. Total of all reporting groups
Overall Number of Baseline Participants 75 78 76 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
 100.0%
78
 100.0%
76
 100.0%
229
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 78 participants 76 participants 229 participants
32.2  (8.9) 31.6  (8.9) 32.7  (9.1) 32.2  (8.9)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
Cisgender Man
40
  53.3%
36
  46.2%
36
  47.4%
112
  48.9%
Cisgender Woman
29
  38.7%
41
  52.6%
37
  48.7%
107
  46.7%
Genderqueer
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.4%
Gender Non-binary
3
   4.0%
1
   1.3%
1
   1.3%
5
   2.2%
Gender Non-conforming
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
Transgender Man/Trans Man
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.4%
Transgender Woman/Trans Woman
1
   1.3%
0
   0.0%
0
   0.0%
1
   0.4%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Decline to state
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
Female
33
  44.0%
42
  53.8%
37
  48.7%
112
  48.9%
Male
42
  56.0%
36
  46.2%
39
  51.3%
117
  51.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
Hispanic or Latino
10
  13.3%
15
  19.2%
22
  28.9%
47
  20.5%
Not Hispanic or Latino
65
  86.7%
63
  80.8%
54
  71.1%
182
  79.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
Asian
11
  14.7%
9
  11.5%
7
   9.2%
27
  11.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  14.7%
13
  16.7%
14
  18.4%
38
  16.6%
White
50
  66.7%
51
  65.4%
47
  61.8%
148
  64.6%
More than one race
2
   2.7%
4
   5.1%
4
   5.3%
10
   4.4%
Unknown or Not Reported
1
   1.3%
1
   1.3%
3
   3.9%
5
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 78 participants 76 participants 229 participants
75 78 76 229
HIV Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
HIV Negative
73
  97.3%
75
  96.2%
73
  96.1%
221
  96.5%
HIV Positive
2
   2.7%
3
   3.8%
3
   3.9%
8
   3.5%
Sexual Identity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 78 participants 76 participants 229 participants
Heterosexual or straight
46
  61.3%
54
  69.2%
48
  63.2%
148
  64.6%
Lesbian or gay
11
  14.7%
10
  12.8%
19
  25.0%
40
  17.5%
Bisexual
13
  17.3%
8
  10.3%
6
   7.9%
27
  11.8%
Queer
2
   2.7%
3
   3.8%
1
   1.3%
6
   2.6%
Pansexual
1
   1.3%
2
   2.6%
0
   0.0%
3
   1.3%
Asexual
2
   2.7%
1
   1.3%
1
   1.3%
4
   1.7%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Decline to state
0
   0.0%
0
   0.0%
1
   1.3%
1
   0.4%
1.Primary Outcome
Title Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43
Hide Description Venous blood was collected at Study Day 43 and the serum was analyzed via the PRNT assay to determine if GMT of the intradermal regimen of 2 x 10^7 TCID50 MVA-BN and 1 x 10^7 TCID50 MVA- BN were non-inferior to that of the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered subcutaneously.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood sample for immunogenicity testing for which valid results were reported. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 74 75 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
203.2
(164.5 to 250.9)
113.2
(90.3 to 141.9)
288.9
(222.4 to 375.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 x 10^7 ID MVA-BN, 1 x 10^8 SC MVA-BN
Comments The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.
Type of Statistical Test Non-Inferiority
Comments The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).
Statistical Test of Hypothesis P-Value 0.045
Comments Significance can be considered if P <0.05. Not adjusted for multiple comparisons.
Method t-test, 2 sided
Comments Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.
Method of Estimation Estimation Parameter Geometric mean titer ratio (GMTR)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.5 to 1.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1 x 10^7 ID MVA-BN, 1 x 10^8 SC MVA-BN
Comments The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.
Type of Statistical Test Non-Inferiority
Comments The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).
Statistical Test of Hypothesis P-Value 0.162
Comments Significance can be considered if P <0.05. Not adjusted for multiple comparisons.
Method t-test, 2 sided
Comments Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.
Method of Estimation Estimation Parameter Geometric mean titer ratio (GMTR)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.3 to 0.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Individual Peak GMT Through Day 365
Hide Description [Not Specified]
Time Frame Day 1 through Day 365
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Hide Description [Not Specified]
Time Frame Day 1 through Day 365
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Vaccinia Virus Specific PRNT Half-life (t ½)
Hide Description [Not Specified]
Time Frame Day 1 through Day 365
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants Reporting Solicited Systemic AEs Through 14 Days After Each Study Vaccination
Hide Description Systemic AEs solicited on a memory aid provided to participants included fever, chills, nausea, headache, fatigue, change in appetite, myalgia, and arthralgia. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29-43 for Dose 2).
Time Frame Day 1 through Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 75 78 76
Measure Type: Count of Participants
Unit of Measure: Participants
59
  78.7%
55
  70.5%
62
  81.6%
6.Secondary Outcome
Title Number of Participants Reporting Solicited Local AEs Through 14 Days After Each Study Vaccination
Hide Description Local AEs solicited on a memory aid provided to participants included pain at injection site, erythema/redness, induration/swelling (functional grade based on interference with daily activity and any measure value greater than 2.5 cm) and pruritis at injection site. Participants are considered reporting the local AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29 through 43 for Dose 2).
Time Frame Day 1 through Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 75 78 76
Measure Type: Count of Participants
Unit of Measure: Participants
73
  97.3%
75
  96.2%
70
  92.1%
7.Secondary Outcome
Title Number of Participants Reporting Unsolicited Related and Unrelated Adverse Events (AEs) Through 28 Days After Each Vaccination
Hide Description Frequency of all unsolicited non-serious AEs from day of each study vaccination through 28 days after each vaccination (Day 1 through Day 29 for Dose 1 and Day 29 through Day 57 for Dose 2).
Time Frame Day 1 through Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 75 78 76
Measure Type: Count of Participants
Unit of Measure: Participants
Related AEs
65
  86.7%
62
  79.5%
37
  48.7%
Unrelated AEs
30
  40.0%
25
  32.1%
18
  23.7%
8.Secondary Outcome
Title Number of Participants Reporting Related and Unrelated Medically Attended Adverse Events (MAAEs)
Hide Description An MAAE is an unsolicited AE that results in unscheduled medical attention such as a hospitalization for less than 24 hours, an emergency room visit, or an otherwise unscheduled healthcare visit for any reason. All MAAEs were collected from Study Day 1 through Study Day 57, and all MAAEs deemed related to the vaccine were collected through Study Day 181.
Time Frame Day 1 through Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 75 78 76
Measure Type: Count of Participants
Unit of Measure: Participants
Related MAAEs
1
   1.3%
0
   0.0%
0
   0.0%
Unrelated MAAEs
11
  14.7%
9
  11.5%
4
   5.3%
9.Secondary Outcome
Title Number of Participants Reporting Related and Unrelated Serious Adverse Events (SAEs)
Hide Description SAEs included any untoward medical occurrence that resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All SAEs were collected from Study Day 1 through Study Day 57, and all SAEs deemed related to the vaccine were collected through Study Day 181.
Time Frame Day 1 through Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description:
0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
Overall Number of Participants Analyzed 75 78 76
Measure Type: Count of Participants
Unit of Measure: Participants
Related SAEs
0
   0.0%
0
   0.0%
0
   0.0%
Unrelated SAEs
0
   0.0%
1
   1.3%
1
   1.3%
10.Secondary Outcome
Title Number of Participants Who Withdrew or Discontinued Vaccination
Hide Description [Not Specified]
Time Frame Day 1 through Day 365
Outcome Measure Data Not Reported
Time Frame Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of each study vaccination through approximately 28 days after each study vaccination. All related SAEs and MAAEs were collected from the time of each study vaccination through approximately 180 days after each study vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Hide Arm/Group Description 0.1 mL of 2 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. 0.05 mL of 1 x 10^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29. 0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
All-Cause Mortality
2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)      0/78 (0.00%)      0/76 (0.00%)    
Hide Serious Adverse Events
2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/75 (0.00%)      1/78 (1.28%)      1/76 (1.32%)    
Infections and infestations       
Cystitis * 1  0/75 (0.00%)  0 1/78 (1.28%)  1 0/76 (0.00%)  0
Metabolism and nutrition disorders       
Euglycaemic diabetic ketoacidosis * 1  0/75 (0.00%)  0 0/78 (0.00%)  0 1/76 (1.32%)  1
1
Term from vocabulary, MedDRA (26.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2 x 10^7 ID MVA-BN 1 x 10^7 ID MVA-BN 1 x 10^8 SC MVA-BN
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/75 (100.00%)      78/78 (100.00%)      75/76 (98.68%)    
Gastrointestinal disorders       
Nausea  1  17/75 (22.67%)  21 15/78 (19.23%)  18 19/76 (25.00%)  21
General disorders       
Chills  1  15/75 (20.00%)  15 13/78 (16.67%)  16 13/76 (17.11%)  15
Fatigue  1  43/75 (57.33%)  60 43/78 (55.13%)  57 53/76 (69.74%)  75
Injection site discolouration * 1  58/75 (77.33%)  94 60/78 (76.92%)  103 9/76 (11.84%)  10
Injection site exfoliation  1  9/75 (12.00%)  12 7/78 (8.97%)  8 0/76 (0.00%)  0
Injection site nodule * 1  51/75 (68.00%)  68 46/78 (58.97%)  59 34/76 (44.74%)  37
Injection site erythema  1  62/75 (82.67%)  110 56/78 (71.79%)  90 40/76 (52.63%)  57
Injection site induration  1 [1]  67/75 (89.33%)  152 74/78 (94.87%)  145 51/76 (67.11%)  100
Injection site induration  1 [2]  37/75 (49.33%)  50 33/78 (42.31%)  39 40/76 (52.63%)  60
Injection site pain  1  49/75 (65.33%)  69 44/78 (56.41%)  64 67/76 (88.16%)  113
Injection site pruritus  1  64/75 (85.33%)  119 73/78 (93.59%)  125 42/76 (55.26%)  62
Infections and infestations       
Upper respiratory tract infection * 1  7/75 (9.33%)  7 4/78 (5.13%)  4 4/76 (5.26%)  4
Metabolism and nutrition disorders       
Appetite disorder  1  11/75 (14.67%)  11 17/78 (21.79%)  21 13/76 (17.11%)  20
Musculoskeletal and connective tissue disorders       
Arthralgia  1  19/75 (25.33%)  22 12/78 (15.38%)  14 13/76 (17.11%)  15
Myalgia  1  24/75 (32.00%)  28 19/78 (24.36%)  25 33/76 (43.42%)  47
Nervous system disorders       
Headache  1  36/75 (48.00%)  45 37/78 (47.44%)  47 43/76 (56.58%)  61
1
Term from vocabulary, MedDRA (26.1)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Functional Grade
[2]
Measurement
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Sharon E. Frey, M.D.
Organization: St. Louis University
Phone: 314-977-5500
EMail: sharon.frey@health.slu.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05512949    
Other Study ID Numbers: 22-0020A
First Submitted: August 20, 2022
First Posted: August 23, 2022
Results First Submitted: November 30, 2023
Results First Posted: January 9, 2024
Last Update Posted: January 9, 2024