mRNA-1189 for EBV Infection

Recruiting at 20 trial locations

Overseen By Moderna WeCare Team

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Disqualifiers: Covid exposure, Unstable illness, Myocarditis, others

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

422 Participants Needed

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.

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. ^{1 2 3 4 5}

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.

Timeline

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

Treatment Details

Interventions

• mRNA-1189

Participant Groups

Group I: Part C: mRNA-1189 Dose Level 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.

Group XII: Part A: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.

Group XIII: Part B: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Epstein-Barr virus gene expression in P3HR1-superinfected Raji cells. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Two major outer envelope glycoproteins of Epstein-Barr virus are encoded by the same gene. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Virus and cell RNAs expressed during Epstein-Barr virus replication. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Two related Epstein-Barr virus membrane proteins are encoded by separate genes. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Mapping of Epstein-Barr virus proteins on the genome by translation of hybrid-selected RNA from induced P3HR1 cells and induced Raji cells. [2019]