A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants
Phase 1
Recruiting
- Conditions
- Epstein-Barr Virus Infection
- Interventions
- Biological: mRNA-1189Biological: mRNA-1195.1Biological: mRNA-1195.2Biological: Placebo
- Registration Number
- NCT05831111
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.
- Detailed Description
There will be 2 sequential parts to the study:
* Participants 18 through 55 years of age will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening.
* Part B will enroll participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 474
Inclusion Criteria
- For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening.
- According to the assessment of the Investigator, is in good general health and can comply with study procedures.
- For 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 3 months following last study injection and is not currently breast/chest feeding.
Key
Exclusion Criteria
- 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.
- Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator).
- 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 study or could interfere with the interpretation of study results.
- History of myocarditis, pericarditis, or myopericarditis.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical corticosteroids and tacrolimus are allowed.
- Participant has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection.
- 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 study.
Note: Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: mRNA-1189 mRNA-1189 Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 3 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 4 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169. Part A: Placebo Placebo Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 4 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169. Part B: Placebo Placebo Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 1 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 2 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 2 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 3 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 High Dose mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 1 mRNA-1195.1 Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169. Part B: mRNA-1195.1 or mRNA-1195.2 High Dose mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169. Part B: mRNA-1189 mRNA-1189 Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 1 mRNA-1195.1 Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 2 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 1 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 2 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169. Part A: Placebo Placebo Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169. Part B: Placebo Placebo Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 3 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 4 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169. Part A: mRNA-1195.2 Dose Level 3 mRNA-1195.2 Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169. Part B: mRNA-1195 Low Dose mRNA-1195 Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169. Part A: mRNA-1195.1 Dose Level 4 mRNA-1195.1 Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169. Part A: mRNA-1189 mRNA-1189 Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169. Part B: mRNA-1195 Middle Dose mRNA-1195 Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169. Part B: mRNA-1195 High Dose mRNA-1195 Participants will receive 3 IM injections of mRNA-1195 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
- Primary Outcome Measures
Name Time Method Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 176 (7-day follow-up after vaccination) Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 197 (28-day follow-up after vaccination) Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs) Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
- Secondary Outcome Measures
Name Time Method Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb Days 1, 85, and 197 Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs Days 1, 85, and 197 Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb) Days 1, 85, and 197
Trial Locations
- Locations (25)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
West Coast Research
🇺🇸Dublin, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Tekton Research
🇺🇸Moore, Oklahoma, United States
Washington Health Institute
🇺🇸Washington, District of Columbia, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Velocity Clinical Research
🇺🇸Binghamton, New York, United States
Optimal Research
🇺🇸Peoria, Illinois, United States
DM Clinical Research- River Forest
🇺🇸River Forest, Illinois, United States
Alliance for Multispecialty Research
🇺🇸Kansas City, Missouri, United States
Johnson County Clin-Trials, Inc (JCCT)
🇺🇸Lenexa, Kansas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Las Vegas Clinical Trials, LLC
🇺🇸North Las Vegas, Nevada, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
Eximia Clinical Research
🇺🇸Raleigh, North Carolina, United States
Tekton Research, Inc
🇺🇸Edmond, Oklahoma, United States
Tekton Research, Inc - Yukon Location
🇺🇸Yukon, Oklahoma, United States
DM Clinical Research - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Benchmark Research
🇺🇸Austin, Texas, United States
Tekton Research Inc.
🇺🇸Austin, Texas, United States
Research Your Health
🇺🇸Plano, Texas, United States