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

Respiratory Syncytial Virus Clinical Trial

— RSVictory  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330975
• Other study ID #: mRNA-1345-P302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2022
• Est. completion date: November 12, 2024

Study information

• Verified date: May 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3800
• Est. completion date: November 12, 2024
• Est. primary completion date: November 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

Intervention

Biological:
• Placebo
0.9% sodium chloride (normal saline) injection
• mRNA-1345
Sterile liquid for injection
• Afluria® Quadrivalent
single-dose, pre-filled syringe for injection
• mRNA-1273.214
Sterile liquid for injection

Locations

Country	Name	City	State
United States	Velocity Clinical Research - Anderson - ERN - PPDS	Anderson	South Carolina
United States	Benchmark Research - Austin - HyperCore - PPDS	Austin	Texas
United States	Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS	Baton Rouge	Louisiana
United States	Tekton Research - Beaumont - Platinum - PPDS	Beaumont	Texas
United States	Central Research Associates Inc	Birmingham	Alabama
United States	Cope Family Medicine - Ogden Clinic	Bountiful	Utah
United States	Teradan Clinical Trials	Brandon	Florida
United States	CHEAR Center LLC - ClinEdge - PPDS	Bronx	New York
United States	Tekton Research - Georgia - Platinum - PPDS	Chamblee	Georgia
United States	Javara Research Inc. - Charlotte - Javara - PPDS	Charlotte	North Carolina
United States	Velocity Clinical Research - Cleveland - ERN - PPDS	Cleveland	Ohio
United States	Zenos Clinical Research	Dallas	Texas
United States	Dolphin Medical Research	Doral	Florida
United States	Revival Research Corporation - Clinedge - PPDS	Doral	Florida
United States	Meridian Clinical Research (Endwell-New York) - Platinum - PPDS	Endwell	New York
United States	Javara Inc./Privia Medical Group INC	Forest	Virginia
United States	Paragon Rx Clinical, Inc	Garden Grove	California
United States	Meridian Clinical Research (Grand Island) - Platinum - PPDS	Grand Island	Nebraska
United States	Velocity Clinical Research - Greenville - ERN - PPDS	Greenville	South Carolina
United States	Indago Research and Health Center	Hialeah	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Westside Center for Clinical Research - ERN - PPDS	Jacksonville	Florida
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Milton Haber, M.D.	Laredo	Texas
United States	Clinical Research Center of Nevada - ERN - PPDS	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada - CCT Research	Las Vegas	Nevada
United States	Lifeline Primary Care / CCT Research	Lilburn	Georgia
United States	Be Well Clinical Studies, LLC	Lincoln	Nebraska
United States	Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS	Lincoln	Nebraska
United States	Ark Clinical Research	Long Beach	California
United States	Long Beach Clinical Trials, LLC (Site 1)	Long Beach	California
United States	Long Beach Clinical Trials, LLC (Site 2)	Long Beach	California
United States	Suncoast Research Associates LLC - ERN - PPDS	Miami	Florida
United States	Suncoast Research Group LLC - ERN-PPDS	Miami	Florida
United States	Floridian Clinical Research - ClinEdge - PPDS	Miami Lakes	Florida
United States	Clinical Research Institute, Inc - CRN - PPDS	Minneapolis	Minnesota
United States	Central Valley Research, LLC	Modesto	California
United States	Tekton Research	Moore	Oklahoma
United States	Trial Management Associates LLC - ERN - PPDS	Myrtle Beach	South Carolina
United States	IMA Medical Research, PC.	New York	New York
United States	Georgia Clinic / CCT Research	Norcross	Georgia
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS	Omaha	Nebraska
United States	Midwest Regional Health Services - CCT Research	Omaha	Nebraska
United States	Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS	Overland Park	Kansas
United States	Velocity Clinical Research - Panorama City	Panorama City	California
United States	Empire Clinical Research	Pomona	California
United States	Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS	Portsmouth	Virginia
United States	M3 Wake Research, Inc - M3 WR - ERN - PPDS	Raleigh	North Carolina
United States	Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS	Rockville	Maryland
United States	Sun Research Institute	San Antonio	Texas
United States	Acclaim Clinical Research	San Diego	California
United States	Medical Center For Clinical Research - M3 WR - ERN - PPDS	San Diego	California
United States	Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS	Savannah	Georgia
United States	Meridian Clinical Research (Sioux City - Iowa)	Sioux City	Iowa
United States	Velocity Clinical Research - Spartanburg - ERN - PPDS	Spartanburg	South Carolina
United States	Meridian Clinical Research - Cincinnati - Platinum - PPDS	Springdale	Ohio
United States	CCT Research at Springville Dermatology	Springville	Utah
United States	Del Sol Research Management - Clinedge - PPDS	Tucson	Arizona
United States	Ark Clinical Research	Tustin	California
United States	Chase Medical Research LLC	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts A and B: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Day 1 through Day 7 (7 days post-injection)
Primary	Part C: Number of Participants with Solicited Local and Systemic ARs 7 Days post-BD		BD Day 1 through Day 7 (7 days post-BD)
Primary	Parts A and B: Number of Participants with Unsolicited Adverse Events (AEs)		Day 1 through Day 28 (28 days post-injection)
Primary	Part C: Number of Participants with Unsolicited AEs 28 Days post-BD Day 1		BD Day 1 through Day 28 (28 days post-BD Day 1)
Primary	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		Day 1 through Day 181
Primary	Part C: Number of Participants With MAAEs From BD Day 1 Through BD Day 181		BD Day 1 through BD Day 181
Primary	Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal From BD Day 1 Through BD Day 361		BD Day 1 through BD Day 361
Primary	Parts A and B: Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29		Day 29
Primary	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		Day 29 to BD Day 29
Primary	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		Day 29 to BD Day 29
Primary	Part A: GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29		Day 29
Primary	Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29		Day 29
Primary	Parts A and B: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 29	Seroresponse is defined as =4 × lower limit of quantification (LLOQ) if baseline is	Baseline to Day 29
Primary	Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to Day 29
Secondary	Parts A and B: GMT of Serum RSV-B Neutralizing Abs at Day 29		Day 29
Secondary	Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to BD Day 29
Secondary	Parts A and B: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to Day 29	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to Day 29
Secondary	Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to BD Day 29
Secondary	Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From 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.	Baseline to Day 29
Secondary	Parts A and B: GMT of Serum RSV-A Neutralizing Abs up to Day 181		up to Day 181
Secondary	Part C: GMT of Serum RSV-A Neutralizing Abs up to BD Day 361		up to BD Day 361
Secondary	Parts A and B: Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs up to Day 181		up to Day 181
Secondary	Part C: GMFR of Serum RSV-A Neutralizing Abs up to BD Day 361		up to BD Day 361
Secondary	Parts A and B: GMT of Serum RSV-B Neutralizing Abs up to Day 181		up to Day 181
Secondary	Part C: GMT of Serum RSV-B Neutralizing Abs up to BD Day 361		up to BD Day 361
Secondary	Parts A and B: GMFR of Serum RSV-B Neutralizing Abs up to Day 181		up to Day 181
Secondary	Part C: GMFR of Serum RSV-B Neutralizing Abs up to BD Day 361		up to BD Day 361
Secondary	Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to BD Day 361	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to BD Day 361
Secondary	Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to BD Day 361	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline to BD Day 361
Secondary	Parts A and B: Percentage of Participants With =2-fold Increases From Baseline in RSV-A Neutralizing Ab Titers up to Day 181		Baseline up to Day 181
Secondary	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		Baseline up to BD Day 361
Secondary	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		Baseline up to Day 181
Secondary	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		Baseline up to BD Day 361
Secondary	Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From 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.	Baseline up to Day 181
Secondary	Part A: GMT of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181		up to Day 181
Secondary	Part A: GMFR of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181		up to Day 181
Secondary	Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181		up to Day 181
Secondary	Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181		up to Day 181
Secondary	Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 181	Seroresponse is defined as =4 × LLOQ if baseline is	Baseline up to Day 181