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.

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a chronic illness that requires ongoing medication changes, you may not be eligible to participate.

How does the drug mRNA-1189 for EBV infection differ from other treatments?

mRNA-1189 is unique because it uses messenger RNA (mRNA) technology, which is a novel approach for treating Epstein-Barr virus (EBV) infections. Unlike traditional treatments that may target the virus directly, mRNA-1189 works by instructing cells to produce proteins that can help the immune system recognize and fight the virus.12345

Are You a Good Fit for This Trial?

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.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 intramuscular injections of mRNA-1189 or placebo on Days 1, 57, and 169

24 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1189
How Is the Trial Designed?
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group II: Part C: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group III: Part C: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Group IV: Part B: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Group V: Part B: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group VI: Part B: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group VII: Part B: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Group VIII: Part A: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Group IX: Part A: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Group X: Part A: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Group XI: Part C: PlaceboPlacebo Group1 Intervention
Group XII: Part A: PlaceboPlacebo Group1 Intervention
Group XIII: Part B: PlaceboPlacebo Group1 Intervention

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

Citations

Epstein-Barr virus gene expression in P3HR1-superinfected Raji cells. [2020]
Two major outer envelope glycoproteins of Epstein-Barr virus are encoded by the same gene. [2020]
Virus and cell RNAs expressed during Epstein-Barr virus replication. [2018]
Two related Epstein-Barr virus membrane proteins are encoded by separate genes. [2020]
Mapping of Epstein-Barr virus proteins on the genome by translation of hybrid-selected RNA from induced P3HR1 cells and induced Raji cells. [2019]
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