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Cancer Vaccine

mRNA-1189 for EBV Infection

Phase 1
Waitlist Available
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you consider the participant to be in stable health, including having an underlying condition that’s well-controlled?
Is the participant not pregnant or breastfeeding, or planning to be pregnant or breastfeeding during their trial participation?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 85, and 197

Summary

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.

Eligible Conditions
  • Epstein-Barr Virus (EBV) Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are in stable health, including having an underlying condition that’s well-controlled.
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If you are a woman, you cannot be pregnant or breastfeeding during their trial participation.
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You must be between 12 and 17 years old to participate.
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Can you commit to visiting the study site around 15 in-person clinic visits and 10 phone calls over 19 months?

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 85, and 197
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 85, and 197 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: 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 II: 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 III: 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 IV: 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 V: 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 VI: 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 VII: 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 VIII: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Group IX: Part B: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
118 Previous Clinical Trials
61,584,817 Total Patients Enrolled

Media Library

mRNA-1189 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05164094 — Phase 1
EBV Infection Research Study Groups: Part A: mRNA-1189 Dose Level 2, Part A: mRNA-1189 Dose Level 3, Part A: mRNA-1189 Dose Level 4, Part A: Placebo, Part B: mRNA-1189 Dose Level 1, Part B: mRNA-1189 Dose Level 2, Part B: mRNA-1189 Dose Level 3, Part B: mRNA-1189 Dose Level 4, Part B: Placebo
EBV Infection Clinical Trial 2023: mRNA-1189 Highlights & Side Effects. Trial Name: NCT05164094 — Phase 1
mRNA-1189 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05164094 — Phase 1
EBV Infection Patient Testimony for trial: Trial Name: NCT05164094 — Phase 1
~62 spots leftby Jun 2025
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