A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age (RSVictory)

• ClinicalTrials.gov Identifier: NCT05330975
• Recruitment Status: Active, not recruiting
• First Posted: April 15, 2022
• Last Update Posted: May 10, 2024
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Study Description

Brief Summary:

The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza.

The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Virus	Biological: Placebo; Biological: mRNA-1345; Biological: Afluria® Quadrivalent; Biological: mRNA-1273.214	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Parts A and B are randomized, observer blind studies and Part C is a single-arm, open-label study.
• Primary Purpose: Prevention
• Official Title: A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age
• Actual Study Start Date: April 1, 2022
• Estimated Primary Completion Date: November 12, 2024
• Estimated Study Completion Date: November 12, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part A: mRNA-1345 + Placebo; Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1345; Sterile liquid for injection
Experimental: Part A: mRNA-1345 + Afluria® Quadrivalent; Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.	Biological: mRNA-1345; Sterile liquid for injection; Biological: Afluria® Quadrivalent; single-dose, pre-filled syringe for injection
Active Comparator: Part A: Afluria® Quadrivalent + Placebo; Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Afluria® Quadrivalent; single-dose, pre-filled syringe for injection
Experimental: Part B: mRNA-1345 + Placebo; Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1345; Sterile liquid for injection; Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: Part B: mRNA-1345 + mRNA-1273.214; Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1345; Sterile liquid for injection; Biological: mRNA-1273.214; Sterile liquid for injection
Active Comparator: Part B: mRNA-1273.214 + Placebo; Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1273.214; Sterile liquid for injection
Experimental: Part C: mRNA-1345; Single injection of mRNA-1345 administered IM on BD Day 1.	Biological: mRNA-1345; Sterile liquid for injection

Outcome Measures

Primary Outcome Measures :

1. Parts A and B: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Day 1 through Day 7 (7 days post-injection) ]
2. Part C: Number of Participants with Solicited Local and Systemic ARs 7 Days post-BD [ Time Frame: BD Day 1 through Day 7 (7 days post-BD) ]
3. Parts A and B: Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Day 1 through Day 28 (28 days post-injection) ]
4. Part C: Number of Participants with Unsolicited AEs 28 Days post-BD Day 1 [ Time Frame: BD Day 1 through Day 28 (28 days post-BD Day 1) ]
5. Parts A and B: Number of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal [ Time Frame: Day 1 through Day 181 ]
6. Part C: Number of Participants With MAAEs From BD Day 1 Through BD Day 181 [ Time Frame: BD Day 1 through BD Day 181 ]
7. Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal From BD Day 1 Through BD Day 361 [ Time Frame: BD Day 1 through BD Day 361 ]
8. Parts A and B: Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29 [ Time Frame: Day 29 ]
9. Part C: GMT Ratio of Serum RSV-A Neutralizing Abs at BD Day 29 Over GMT of serum RSV-A Neutralizing Abs at Day 29 Post Primary Dose [ Time Frame: Day 29 to BD Day 29 ]
10. Part C: GMT Ratio of Serum RSV-B Neutralizing Abs at BD Day 29 Over GMT of serum RSV-B Neutralizing Abs at Day 29 Post Primary Dose [ Time Frame: Day 29 to BD Day 29 ]
11. Part A: GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 [ Time Frame: Day 29 ]
12. Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29 [ Time Frame: Day 29 ]
13. Parts A and B: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 29 [ Time Frame: Baseline to Day 29 ]
    Seroresponse is defined as ≥4 × lower limit of quantification (LLOQ) if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-A neutralizing Ab titers at Day 29.
14. Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29 [ Time Frame: Baseline to Day 29 ]
    Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in SARS-CoV-2 neutralizing Ab titers at Day 29.

Secondary Outcome Measures :

1. Parts A and B: GMT of Serum RSV-B Neutralizing Abs at Day 29 [ Time Frame: Day 29 ]
2. Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29 [ Time Frame: Baseline to BD Day 29 ]
   Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-A neutralizing Ab titers at BD Day 29.
3. Parts A and B: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to Day 29 [ Time Frame: Baseline to Day 29 ]
   Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-B neutralizing Ab titers at BD Day 29.
4. Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29 [ Time Frame: Baseline to BD Day 29 ]
   Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-B neutralizing Ab titers at BD Day 29.
5. Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline to Day 29 [ Time Frame: Baseline to Day 29 ]
   Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-hemagglutinin (anti-HA) Abs measured by HAI assay.
6. Parts A and B: GMT of Serum RSV-A Neutralizing Abs up to Day 181 [ Time Frame: up to Day 181 ]
7. Part C: GMT of Serum RSV-A Neutralizing Abs up to BD Day 361 [ Time Frame: up to BD Day 361 ]
8. Parts A and B: Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs up to Day 181 [ Time Frame: up to Day 181 ]
9. Part C: GMFR of Serum RSV-A Neutralizing Abs up to BD Day 361 [ Time Frame: up to BD Day 361 ]
10. Parts A and B: GMT of Serum RSV-B Neutralizing Abs up to Day 181 [ Time Frame: up to Day 181 ]
11. Part C: GMT of Serum RSV-B Neutralizing Abs up to BD Day 361 [ Time Frame: up to BD Day 361 ]
12. Parts A and B: GMFR of Serum RSV-B Neutralizing Abs up to Day 181 [ Time Frame: up to Day 181 ]
13. Part C: GMFR of Serum RSV-B Neutralizing Abs up to BD Day 361 [ Time Frame: up to BD Day 361 ]
14. Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to BD Day 361 [ Time Frame: Baseline to BD Day 361 ]
    Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-A neutralizing Ab titers at BD Day 361.
15. Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to BD Day 361 [ Time Frame: Baseline to BD Day 361 ]
    Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in RSV-B neutralizing Ab titers at BD Day 361.
16. Parts A and B: Percentage of Participants With ≥2-fold Increases From Baseline in RSV-A Neutralizing Ab Titers up to Day 181 [ Time Frame: Baseline up to Day 181 ]
17. Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Defined as Before Primary Dose) in RSV-A Neutralizing Ab Titers up to BD Day 361 [ Time Frame: Baseline up to BD Day 361 ]
18. Parts A and B: Percentage of Participants With ≥2-fold and ≥4- fold Increases From Baseline in RSV-B Neutralizing Ab Titers up to Day 181 [ Time Frame: Baseline up to Day 181 ]
19. Part C: Percentage of Participants With ≥2-fold Increases From Baseline (Defined as Before Primary Dose) in RSV-B Neutralizing Ab Titers up to BD Day 361 [ Time Frame: Baseline up to BD Day 361 ]
20. Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline up to Day 181 [ Time Frame: Baseline up to Day 181 ]
    Seroconversion is defined as a Day 181/EOS titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA Abs measured by HAI assay.
21. Part A: GMT of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181 [ Time Frame: up to Day 181 ]
22. Part A: GMFR of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181 [ Time Frame: up to Day 181 ]
23. Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181 [ Time Frame: up to Day 181 ]
24. Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181 [ Time Frame: up to Day 181 ]
25. Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 181 [ Time Frame: Baseline up to Day 181 ]
    Seroresponse is defined as ≥4 × LLOQ if baseline is <LLOQ or 4-fold or greater increase from baseline if baseline is ≥LLOQ in SARS-CoV-2 strain neutralizing Ab titers at Day 181.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Key Inclusion Criteria:

Parts A and B both:

• Adults ≥50 years of age on the day of the Randomization Visit (Day 1) who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: Absence of changes in medical therapy within 1 month due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 1 month of the planned vaccination on Day 1; and absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely.
• Able to comply with study requirements, including access to transportation for study visits.

Part B only:

• Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. If the most recent COVID-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) Day 1. If the most recent COVID-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) Day 1.

Part C:

• Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day 211/end-of-study visits for Part B; were included in the per-protocol (PP) set; and received 1 dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of enrollment.
• Able to comply with study requirements, including access to transportation for study visits.

Key Exclusion Criteria:

Part A:

• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
• Prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the Randomization Visit (Day 1).
• History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
• Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

Part B:

• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections (with the exception of SARS-Cov-2 vaccination).
• Prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of RSV investigation products) within 45 days before the planned date of the Day 1 study injection.
• Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 study injection.
• Has known history of SARS-CoV-2 infection within 90 days prior to enrollment.

Parts A and B both:

• Participant had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 10 days, as defined by the United States (US) Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.

Part C:

• Participation in another interventional clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the BD Day 1 study injection. Any prior receipt of an investigational or approved vaccine against RSV, except as part of mRNA-1345 Study P302 Part B, is exclusionary.
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
• History of a serious reaction to any prior vaccination or Guillain-Barré syndrome 6 weeks after any prior influenza immunization.

Other inclusion and/or exclusion criteria may apply.

Contacts and Locations

Locations

United States, Alabama

Central Research Associates Inc

Birmingham, Alabama, United States, 35205

United States, Arizona

Del Sol Research Management - Clinedge - PPDS

Tucson, Arizona, United States, 85715

United States, California

Paragon Rx Clinical, Inc

Garden Grove, California, United States, 92703-1811

Ark Clinical Research

Long Beach, California, United States, 90806

Long Beach Clinical Trials, LLC (Site 1)

Long Beach, California, United States, 90806

Long Beach Clinical Trials, LLC (Site 2)

Long Beach, California, United States, 90806

Central Valley Research, LLC

Modesto, California, United States, 95350

Velocity Clinical Research - Panorama City

Panorama City, California, United States, 91402-3022

Empire Clinical Research

Pomona, California, United States, 91786

Acclaim Clinical Research

San Diego, California, United States, 92120

Medical Center For Clinical Research - M3 WR - ERN - PPDS

San Diego, California, United States, 92120

Ark Clinical Research

Tustin, California, United States, 92780

United States, Connecticut

Chase Medical Research LLC

Waterbury, Connecticut, United States, 06708

United States, Florida

Teradan Clinical Trials

Brandon, Florida, United States, 33511-4925

Revival Research Corporation - Clinedge - PPDS

Doral, Florida, United States, 33122

Dolphin Medical Research

Doral, Florida, United States, 33172

Indago Research and Health Center

Hialeah, Florida, United States, 33012

Westside Center for Clinical Research - ERN - PPDS

Jacksonville, Florida, United States, 32205

Floridian Clinical Research - ClinEdge - PPDS

Miami Lakes, Florida, United States, 33016

Suncoast Research Group LLC - ERN-PPDS

Miami, Florida, United States, 33135

Suncoast Research Associates LLC - ERN - PPDS

Miami, Florida, United States, 33173

United States, Georgia

Tekton Research - Georgia - Platinum - PPDS

Chamblee, Georgia, United States, 30341

Lifeline Primary Care / CCT Research

Lilburn, Georgia, United States, 30047-2832

Georgia Clinic / CCT Research

Norcross, Georgia, United States, 30092-4544

Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

Savannah, Georgia, United States, 31406

United States, Hawaii

East-West Medical Research Institute

Honolulu, Hawaii, United States, 96814

United States, Iowa

Meridian Clinical Research (Sioux City - Iowa)

Sioux City, Iowa, United States, 51106

United States, Kansas

Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS

Overland Park, Kansas, United States, 66210-1863

United States, Louisiana

Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS

Baton Rouge, Louisiana, United States, 70809

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, United States, 70601

United States, Maryland

Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS

Rockville, Maryland, United States, 20854-2957

United States, Minnesota

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, United States, 55402

United States, Nebraska

Meridian Clinical Research (Grand Island) - Platinum - PPDS

Grand Island, Nebraska, United States, 68803

Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS

Lincoln, Nebraska, United States, 68510

Be Well Clinical Studies, LLC

Lincoln, Nebraska, United States, 68516

Meridian Clinical Research

Norfolk, Nebraska, United States, 68701

Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS

Omaha, Nebraska, United States, 68134

Midwest Regional Health Services - CCT Research

Omaha, Nebraska, United States, 68144

United States, Nevada

Clinical Research Center of Nevada - ERN - PPDS

Las Vegas, Nevada, United States, 89106

Santa Rosa Medical Centers of Nevada - CCT Research

Las Vegas, Nevada, United States, 89119-5483

United States, New York

CHEAR Center LLC - ClinEdge - PPDS

Bronx, New York, United States, 10455-3908

Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

Endwell, New York, United States, 13760

IMA Medical Research, PC.

New York, New York, United States, 10036-4103

United States, North Carolina

Javara Research Inc. - Charlotte - Javara - PPDS

Charlotte, North Carolina, United States, 28210

M3 Wake Research, Inc - M3 WR - ERN - PPDS

Raleigh, North Carolina, United States, 27612

United States, Ohio

Velocity Clinical Research - Cleveland - ERN - PPDS

Cleveland, Ohio, United States, 44122

Meridian Clinical Research - Cincinnati - Platinum - PPDS

Springdale, Ohio, United States, 45246

United States, Oklahoma

Tekton Research

Moore, Oklahoma, United States, 73160-1386

United States, South Carolina

Velocity Clinical Research - Anderson - ERN - PPDS

Anderson, South Carolina, United States, 29621

Velocity Clinical Research - Greenville - ERN - PPDS

Greenville, South Carolina, United States, 29615

Trial Management Associates LLC - ERN - PPDS

Myrtle Beach, South Carolina, United States, 29572-4612

Velocity Clinical Research - Spartanburg - ERN - PPDS

Spartanburg, South Carolina, United States, 29303-4225

United States, Tennessee

New Phase Research &amp; Development

Knoxville, Tennessee, United States, 37909

United States, Texas

Benchmark Research - Austin - HyperCore - PPDS

Austin, Texas, United States, 78705

Tekton Research - Beaumont - Platinum - PPDS

Beaumont, Texas, United States, 77706

Zenos Clinical Research

Dallas, Texas, United States, 75230

Milton Haber, M.D.

Laredo, Texas, United States, 78041

Sun Research Institute

San Antonio, Texas, United States, 78215-1922

United States, Utah

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, United States, 84010-4862

CCT Research at Springville Dermatology

Springville, Utah, United States, 84663

United States, Virginia

Javara Inc./Privia Medical Group INC

Forest, Virginia, United States, 24551

Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

Portsmouth, Virginia, United States, 23703

Sponsors and Collaborators

ModernaTX, Inc.

More Information

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT05330975
• Other Study ID Numbers: mRNA-1345-P302
• First Posted: April 15, 2022
• Last Update Posted: May 10, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ModernaTX, Inc.:

Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Respiratory syncytial virus; Safety; Vaccines; SARS-CoV-2

Additional relevant MeSH terms:

Virus Diseases; Infections