mRNA EBV Vaccine for EBV Infection
Recruiting at47 trial locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: ModernaTX, Inc.
Trial Summary
What is the purpose of this trial?
This trial tests the safety of a new vaccine called mRNA-1195 in healthy adults. The study is split into two parts based on whether participants have been exposed to Epstein-Barr Virus. The vaccine works by teaching the body to recognize and fight the virus.
Research Team
Eligibility Criteria
This trial is for healthy adults aged 18-55 who either have been exposed to EBV (Part A) or not (Part B). Participants must be in good health, able to follow the study plan, and if female and able to become pregnant, they must use effective birth control. People with recent fevers, unstable chronic illnesses, drug/alcohol abuse history, or those on certain immune-altering drugs can't join.Inclusion Criteria
For Part A: Positive EBV serostatus at Screening
For Part B: Negative EBV serostatus at Screening
Is in good general health and can comply with study procedures
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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
My chronic illness is stable and hasn't required new treatments in the last 2 months.
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
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Treatment Details
Interventions
- mRNA-1195 (Cancer Vaccine)
Trial OverviewThe study tests the safety of an Epstein-Barr Virus vaccine called mRNA-1195 in two forms (mRNA-1195.1 and mRNA-1195.2), comparing it against another candidate vaccine mRNA-1189 and a placebo. The goal is to see how participants' bodies react to these vaccines.
Participant Groups
14Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part B: mRNA-1195 Middle DoseExperimental Treatment1 Intervention
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.
Group II: Part B: mRNA-1195 Low DoseExperimental Treatment1 Intervention
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.
Group III: Part B: mRNA-1195 High DoseExperimental Treatment1 Intervention
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.
Group IV: Part A: mRNA-1195.2 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Group V: Part A: mRNA-1195.2 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Group VI: Part A: mRNA-1195.2 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Group VII: Part A: mRNA-1195.2 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Group VIII: Part A: mRNA-1195.1 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Group IX: Part A: mRNA-1195.1 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Group X: Part A: mRNA-1195.1 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Group XI: Part A: mRNA-1195.1 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Group XII: Part A: mRNA-1189Active Control1 Intervention
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Group XIII: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Group XIV: Part B: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Trials
127
Recruited
66,790,000+
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris