422 Participants Needed

mRNA-1189 for EBV Infection

Recruiting at 20 trial locations
MC
MW
Overseen ByModerna WeCare Team
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ModernaTX, Inc.

Trial Summary

What is the purpose of this trial?

This trial tests the safety and body response to the mRNA-1189 vaccine in healthy adults and adolescents. The vaccine uses mRNA to help the body recognize and fight off a virus.

Eligibility Criteria

Inclusion Criteria

You must be between 12 and 17 years old to participate.
If you are a woman, you cannot be pregnant or breastfeeding during their trial participation.
You are in stable health, including having an underlying condition that’s well-controlled.
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Treatment Details

Interventions

  • mRNA-1189
Participant Groups
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Group II: Part C: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Group III: Part C: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Group IV: Part B: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Group V: Part B: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Group VI: Part B: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Group VII: Part B: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Group VIII: Part A: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Group IX: Part A: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Group X: Part A: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Group XI: Part C: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Group XII: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Group XIII: Part B: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection 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 profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris