A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
- Conditions
- InfluenzaSARS-CoV-2
- Interventions
- Biological: Investigational COVID-19 Vaccine 1Biological: COVID-19 Vaccine 1Biological: Influenza Vaccine 2Biological: Investigational Influenza Vaccine 1Biological: Influenza Vaccine 1Biological: Investigational Influenza Vaccine 2Biological: COVID-19 Vaccine 2Biological: Investigational COVID-19 Vaccine 2
- Registration Number
- NCT05827926
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.
The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.
- Detailed Description
Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to \<80 years of age or Cohort B for adults ≥18 to \<65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to \<50 years and ≥50 to \<65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).
Part 2: Approximately, 520 participants between ≥18 to \<50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1763
Part 1 (Phase 1/2)
- Adults ≥18 to <80 years of age at the time of consent.
- Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the Screening Visit.
- Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
- Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1.
Part 2 (Phase 2 Extension)
- Adults ≥18 to <50 years of age at the time of consent.
- BMI of 18 kg/m^2 to 35 kg/m^2 (inclusive) at the Screening Visit.
- Healthy as determined by medical evaluation, including medical history, and physical examination.
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
- Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.
Key
Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension)
- Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results.
- Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
- Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
- Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
- Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
- Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial.
- Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.
Part 2 (Phase 2 Extension) Only
- Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.
Note: Other inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Cohort B4: mRNA-1083.2 Dose A mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1. Part 2: mRNA-1083 Composition 1 Dose A mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1. Part 2: mRNA-1083 Composition 2 Dose A mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1. Part 1 Cohort A9: Investigational COVID-19 Vaccine 1 Investigational COVID-19 Vaccine 1 Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1. Part 1 Cohort A2: mRNA-1083.1 Dose B mRNA-1083.1 Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1. Part 1 Cohort B10: COVID-19 Vaccine 1 COVID-19 Vaccine 1 Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1. Part 1 Cohort A13: Influenza Vaccine 2 Influenza Vaccine 2 Participants will receive single IM injection of Influenza Vaccine 2 on Day 1. Part 1 Cohort A7: mRNA-1083.3 mRNA-1083.3 Participants will receive single IM injection of mRNA-1083.3 on Day 1. Part 1 Cohort B7: mRNA-1083.3 mRNA-1083.3 Participants will receive single IM injection of mRNA-1083.3 on Day 1. Part 1 Cohort A4: mRNA-1083.2 Dose A mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1. Part 1 Cohort A3: mRNA-1083.1 Dose C mRNA-1083.1 Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1. Part 1 Cohort A5: mRNA-1083.2 Dose B mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1. Part 1 Cohort A10: COVID-19 Vaccine 1 COVID-19 Vaccine 1 Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1. Part 1 Cohort B5: mRNA-1083.2 Dose B mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1. Part 1 Cohort B9: Investigational COVID-19 Vaccine 1 Investigational COVID-19 Vaccine 1 Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1. Part 2: Investigational Influenza Vaccine 1 Dose A Investigational Influenza Vaccine 1 Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1. Part 1 Cohort A12: Influenza Vaccine 1 Influenza Vaccine 1 Participants will receive single IM injection of Influenza Vaccine 1 on Day 1. Part 1 Cohort B12: Influenza Vaccine 1 Influenza Vaccine 1 Participants will receive single IM injection of Influenza Vaccine 1 on Day 1. Part 2: mRNA-1083 Composition 1 Dose B mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1. Part 2: Influenza Vaccine 1 Influenza Vaccine 1 Participants will receive single IM injection of Influenza Vaccine 1 on Day 1. Part 1 Cohort A6: mRNA-1083.2 Dose C mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1. Part 1 Cohort B2: mRNA-1083.1 Dose B mRNA-1083.1 Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1. Part 1 Cohort B3: mRNA-1083.1 Dose C mRNA-1083.1 Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1. Part 1 Cohort B6: mRNA-1083.2 Dose C mRNA-1083.2 Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1. Part 2: mRNA-1083 Composition 2 Dose D mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1. Part 2: mRNA-1083 Composition 1 Dose D mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1. Part 1 Cohort A8: Investigational Influenza Vaccine 1 Investigational Influenza Vaccine 1 Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1. Part 1 Cohort A11: Investigational Influenza Vaccine 2 Investigational Influenza Vaccine 2 Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1. Part 1 Cohort B1: mRNA-1083.1 Dose A mRNA-1083.1 Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1. Part 1 Cohort B8: Investigational Influenza Vaccine 1 Investigational Influenza Vaccine 1 Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1. Part 1 Cohort B11: Investigational Influenza Vaccine 2 Investigational Influenza Vaccine 2 Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1. Part 2: mRNA-1083 Composition 2 Dose B mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1. Part 2: mRNA-1083 Composition 1 Dose C mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1. Part 2: mRNA-1083 Composition 2 Dose C mRNA-1083 Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1. Part 2: Investigational Influenza Vaccine 1 Dose B Investigational Influenza Vaccine 1 Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1. Part 2: COVID-19 Vaccine 2 COVID-19 Vaccine 2 Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1. Part 2: Investigational COVID-19 Vaccine 2 Investigational COVID-19 Vaccine 2 Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
- Primary Outcome Measures
Name Time Method Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29 Compared to Baseline (Day 1), as Measured by PsVNA Baseline (Day 1), Day 29 Part 2: Influenza: Percentage of Participants with Seroconversion at Day 29, as Measured by HAI Assay Baseline (Day 1) 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-HA antibodies measured by HAI assay.
Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) Baseline (Day 1), Day 29 Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 7 (7 days after vaccination) Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 29, as Measured by PsVNA Baseline (Day 1) to Day 29 Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in neutralizing antibody (nAb) titers measured by PsVNA.
Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs Up to Day 28 (28 days after vaccination) Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study Day 1 through Day 181 Part 2: Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay Baseline (Day 1), Day 29 Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29 Compared to Baseline (Day 1), as Measured by HAI Assay Baseline (Day 1), Day 29
- Secondary Outcome Measures
Name Time Method Part 1: Change From Baseline in GMT of Antibodies for Influenza, as Measured by HAI Assay Baseline (Day 1), Day 29, and Day 181 Part 1: GMFR of Antibodies for Influenza at Days 29 and 181 Compared to Baseline (Day 1), as Measured by HAI Assay Baseline (Day 1), Day 29, and Day 181 Part 1: Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay Baseline (Day 1) to Day 29, and Day 181 Seroconversion is defined as a Day 29 and Day 181 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Part 2: Change From Baseline in GMT of Antibodies for Influenza at Day 181, as Measured by HAI Assay Baseline (Day 1), Day 181 Part 1: Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA Baseline (Day 1), Day 29, and Day 181 Part 1: GMFR of Antibodies for SARS-CoV-2 at Days 29 and 181 Compared to Baseline (Day 1), as Measured by PsVNA Baseline (Day 1), Day 29, and Day 181 Part 1: SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA Baseline (Day 1) to Day 29, and Day 181 Seroresponse is defined as a Day 29 and Day 181 titer ≥4-fold if baseline is ≥LLOQ or ≥4\*LLOQ if baseline titer is \<LLOQ in nAb titers measured by PsVNA.
Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 181 Compared to Baseline (Day 1), as Measured by PsVNA Baseline (Day 1), Day 181 Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 181, as Measured by PsVNA Baseline (Day 1) to Day 181 Seroresponse is defined as a Day 181 titer ≥4-fold if baseline is ≥LLOQ or ≥4\*LLOQ if baseline titer is \<LLOQ in nAb titers measured by PsVNA.
Part 2: GMFR of Antibodies for Influenza at Day 181 Compared to Baseline (Day 1), as Measured by HAI Assay Baseline (Day 1), Day 181 Part 2: Influenza: Percentage of Participants with Seroconversion at Day 181, as Measured by HAI Assay Baseline (Day 1) to Day 181 Seroconversion is defined as a Day 181 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 181, as Measured by PsVNA Baseline (Day 1), Day 181
Trial Locations
- Locations (43)
Centricity Research
🇺🇸Columbus, Ohio, United States
Texas Center for Drug Development
🇺🇸Houston, Texas, United States
Tekton Research
🇺🇸San Antonio, Texas, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
CenExel
🇺🇸Hollywood, Florida, United States
Accel Research Site
🇺🇸Decatur, Georgia, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
Johnson County Clin-Trials
🇺🇸Lenexa, Kansas, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Central Valley Research
🇺🇸Modesto, California, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Annapolis Internal Medicine
🇺🇸Annapolis, Maryland, United States
DelRicht Research
🇺🇸McKinney, Texas, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Tryon Medical Partners
🇺🇸Charlotte, North Carolina, United States
WellNow Urgent Care & Research
🇺🇸Dayton, Ohio, United States
Ogden Clinic
🇺🇸Roy, Utah, United States
Mercado Medical Practice
🇺🇸Philadelphia, Pennsylvania, United States
Tekton Research Inc
🇺🇸Yukon, Oklahoma, United States
Cyfair Clinical Research
🇺🇸Houston, Texas, United States
Meridian Clinical Research
🇺🇸Hampton, Virginia, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Lynn Institute of East Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
CCT Research
🇺🇸Pleasant View, Utah, United States
CenExel iResearch
🇺🇸Decatur, Georgia, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Koch Family Medicine
🇺🇸Morton, Illinois, United States
Lifeline Primary Care
🇺🇸Lilburn, Georgia, United States
Optimal Research
🇺🇸Peoria, Illinois, United States
Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Accel Research Sites
🇺🇸Maitland, Florida, United States
Velocity Clinical Research
🇺🇸Portsmouth, Virginia, United States
DM Clinical Research
🇺🇸Philadelphia, Pennsylvania, United States
Vida Clinical Studies
🇺🇸Dearborn Heights, Michigan, United States
Wenatchee Valley Hospital & Clinics Campus
🇺🇸Wenatchee, Washington, United States
Clay Platte Family Medicine
🇺🇸Kansas City, Missouri, United States
Velocity Clinical research
🇺🇸Baton Rouge, Louisiana, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Medical Care
🇺🇸Elizabethton, Tennessee, United States