mRNA-1345 Vaccine for RSV

Recruiting in Palo Alto (17 mi)

+47 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ModernaTX, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests the safety and immune response of the mRNA-1345 vaccine in high-risk adults and those with organ transplants. The vaccine uses genetic instructions to help the body recognize and fight the virus.

Research Team

Eligibility Criteria

This trial is for adults aged 18-59 with heart disease, chronic lung conditions, or stable diabetes on medication. It's also for those over 18 who've had an organ transplant and are on anti-rejection drugs. People can't join if they're in another study, have unstable health issues that could affect safety or results, severe allergies to the vaccine ingredients, recent use of immune-modifying drugs, a history of certain heart inflammations, or recent organ rejection.

Inclusion Criteria

You are 18 years of age or older.

You have received a lung transplant at least 6 months ago.

You have received a lung transplant at least 6 months ago.

Treatment Details

Interventions

• mRNA-1345 (Cancer Vaccine)

Trial Overview The trial tests mRNA-1345 vaccine's safety and immune response in two groups: high-risk adults (Part A) and adult solid organ transplant recipients (Part B). The goal is to see how well the vaccine works in these different populations who are at higher risk from respiratory syncytial virus.

Participant Groups

Group I: Part B: mRNA-1345 Dose 2 Experimental Treatment 1 Intervention

Two injections of mRNA-1345 administered IM on Day 1 and Day 57.

Group II: Part A: mRNA-1345 Dose 2 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 administered IM on Day 1.

Group III: Part A: mRNA-1345 Dose 1 Experimental Treatment 1 Intervention

Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.

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