A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Biological: mRNA-1345Biological: PlaceboBiological: Afluria® QuadrivalentBiological: mRNA-1273.214
- Registration Number
- NCT05330975
- Lead Sponsor
- ModernaTX, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3800
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: mRNA-1345 + Afluria® Quadrivalent mRNA-1345 Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1. Part B: mRNA-1345 + Placebo 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. Part B: mRNA-1345 + Placebo mRNA-1273.214 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. Part A: mRNA-1345 + Placebo mRNA-1345 Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1. Part C: mRNA-1345 mRNA-1345 Single injection of mRNA-1345 administered IM on BD Day 1. Part A: mRNA-1345 + Afluria® Quadrivalent Afluria® Quadrivalent Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1. Part A: Afluria® Quadrivalent + Placebo Placebo Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1. Part A: Afluria® Quadrivalent + Placebo Afluria® Quadrivalent Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1. Part B: mRNA-1345 + Placebo mRNA-1345 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. Part B: mRNA-1345 + mRNA-1273.214 Placebo 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. Part B: mRNA-1345 + mRNA-1273.214 mRNA-1345 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. Part B: mRNA-1345 + mRNA-1273.214 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. Part B: mRNA-1273.214 + Placebo 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. Part B: mRNA-1273.214 + Placebo mRNA-1273.214 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. Part A: mRNA-1345 + Placebo Placebo Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
- Primary Outcome Measures
Name Time Method Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29 Day 29 Parts A and B: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Day 1 through Day 7 (7 days post-injection) Parts A and B: Number of Participants with Unsolicited Adverse Events (AEs) Day 1 through Day 28 (28 days post-injection) 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) 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 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 Part A: GMT of Serum Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29 Day 29 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) 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 Part C: Number of Participants With MAAEs From BD Day 1 Through BD Day 181 BD Day 1 through BD Day 181 Parts A and B: Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29 Day 29 Parts A and B: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to Day 29 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.
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 Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 29 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
Name Time Method Parts A and B: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to Day 29 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.
Parts A and B: GMT of Serum RSV-A Neutralizing Abs up to Day 181 up to Day 181 Parts A and B: GMT of Serum RSV-B Neutralizing Abs at Day 29 Day 29 Part C: GMT of Serum RSV-B Neutralizing Abs up to BD Day 361 up to BD Day 361 Part C: GMFR of Serum RSV-B Neutralizing Abs up to BD Day 361 up to BD Day 361 Parts A and B: GMFR of Serum RSV-B Neutralizing Abs up to Day 181 up to Day 181 Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29 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.
Part C: GMT of Serum RSV-A Neutralizing Abs up to BD Day 361 up to BD Day 361 Parts A and B: GMT of Serum RSV-B Neutralizing Abs up to Day 181 up to Day 181 Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline to BD Day 361 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.
Part C: Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs From Baseline (Defined as Before Primary Dose) to BD Day 29 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.
Parts A and B: Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs up to Day 181 up to Day 181 Part C: GMFR of Serum RSV-A Neutralizing Abs up to BD Day 361 up to BD Day 361 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 Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline up to Day 181 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.
Part B: GMFR of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181 up to Day 181 Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains From Baseline to Day 29 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.
Part C: Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs From Baseline to BD Day 361 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.
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 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 Part A: GMT of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181 up to Day 181 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 Part A: GMFR of Serum Ab Level, as Measured by HAI Assay for Influenza up to Day 181 up to Day 181 Part B: GMC of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 up to Day 181 up to Day 181 Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 Neutralizing Abs From Baseline to Day 181 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.
Trial Locations
- Locations (61)
Floridian Clinical Research - ClinEdge - PPDS
🇺🇸Miami Lakes, Florida, United States
Suncoast Research Associates LLC - ERN - PPDS
🇺🇸Miami, Florida, United States
Santa Rosa Medical Centers of Nevada - CCT Research
🇺🇸Las Vegas, Nevada, United States
Del Sol Research Management - Clinedge - PPDS
🇺🇸Tucson, Arizona, United States
Teradan Clinical Trials
🇺🇸Brandon, Florida, United States
Lifeline Primary Care / CCT Research
🇺🇸Lilburn, Georgia, United States
Meridian Clinical Research (Sioux City - Iowa)
🇺🇸Sioux City, Iowa, United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
🇺🇸Savannah, Georgia, United States
Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
🇺🇸Baton Rouge, Louisiana, United States
M3 Wake Research, Inc - M3 WR - ERN - PPDS
🇺🇸Raleigh, North Carolina, United States
Velocity Clinical Research - Anderson - ERN - PPDS
🇺🇸Anderson, South Carolina, United States
Tekton Research - Beaumont - Platinum - PPDS
🇺🇸Beaumont, Texas, United States
Milton Haber, M.D.
🇺🇸Laredo, Texas, United States
Cope Family Medicine - Ogden Clinic
🇺🇸Bountiful, Utah, United States
CCT Research at Springville Dermatology
🇺🇸Springville, Utah, United States
Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS
🇺🇸Overland Park, Kansas, United States
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
Dolphin Medical Research
🇺🇸Doral, Florida, United States
Westside Center for Clinical Research - ERN - PPDS
🇺🇸Jacksonville, Florida, United States
Trial Management Associates LLC - ERN - PPDS
🇺🇸Myrtle Beach, South Carolina, United States
Suncoast Research Group LLC - ERN-PPDS
🇺🇸Miami, Florida, United States
Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
🇺🇸Rockville, Maryland, United States
Meridian Clinical Research
🇺🇸Norfolk, Nebraska, United States
Revival Research Corporation - Clinedge - PPDS
🇺🇸Doral, Florida, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
Clinical Research Center of Nevada - ERN - PPDS
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research - Greenville - ERN - PPDS
🇺🇸Greenville, South Carolina, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Clinical Trials of SWLA, LLC
🇺🇸Lake Charles, Louisiana, United States
Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
🇺🇸Lincoln, Nebraska, United States
Be Well Clinical Studies, LLC
🇺🇸Lincoln, Nebraska, United States
Meridian Clinical Research (Grand Island) - Platinum - PPDS
🇺🇸Grand Island, Nebraska, United States
Paragon Rx Clinical, Inc
🇺🇸Garden Grove, California, United States
Ark Clinical Research
🇺🇸Tustin, California, United States
Long Beach Clinical Trials, LLC (Site 2)
🇺🇸Long Beach, California, United States
Long Beach Clinical Trials, LLC (Site 1)
🇺🇸Long Beach, California, United States
Velocity Clinical Research - Panorama City
🇺🇸Panorama City, California, United States
Central Valley Research, LLC
🇺🇸Modesto, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Georgia Clinic / CCT Research
🇺🇸Norcross, Georgia, United States
Tekton Research - Georgia - Platinum - PPDS
🇺🇸Chamblee, Georgia, United States
IMA Medical Research, PC.
🇺🇸New York, New York, United States
Velocity Clinical Research - Cleveland - ERN - PPDS
🇺🇸Cleveland, Ohio, United States
Tekton Research
🇺🇸Moore, Oklahoma, United States
Javara Research Inc. - Charlotte - Javara - PPDS
🇺🇸Charlotte, North Carolina, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
🇺🇸Endwell, New York, United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
🇺🇸Springdale, Ohio, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Javara Inc./Privia Medical Group INC
🇺🇸Forest, Virginia, United States
Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
🇺🇸Portsmouth, Virginia, United States
CHEAR Center LLC - ClinEdge - PPDS
🇺🇸Bronx, New York, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research - Spartanburg - ERN - PPDS
🇺🇸Spartanburg, South Carolina, United States
Central Research Associates Inc
🇺🇸Birmingham, Alabama, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
Medical Center For Clinical Research - M3 WR - ERN - PPDS
🇺🇸San Diego, California, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research Institute, Inc - CRN - PPDS
🇺🇸Minneapolis, Minnesota, United States
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
🇺🇸Omaha, Nebraska, United States
Midwest Regional Health Services - CCT Research
🇺🇸Omaha, Nebraska, United States
Benchmark Research - Austin - HyperCore - PPDS
🇺🇸Austin, Texas, United States