mRNA-1345 Vaccine for RSV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, mRNA-1345, to evaluate its safety and effectiveness in boosting the immune response against RSV, a virus that causes lung infections. Part A focuses on adults under 60 with conditions such as heart disease, chronic lung disease, or diabetes. Part B targets adults who have undergone a kidney, liver, or lung transplant and are on medication to prevent organ rejection. Individuals who can care for themselves and have one of these conditions might be suitable for the trial. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are in Part A, you should not have been on chronic immunosuppressants or immune-modifying drugs for more than 14 days within 180 days before starting the trial. If you are in Part B, you should not have had certain treatments like alemtuzumab or rituximab within 2 years before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the mRNA-1345 vaccine is generally well-tolerated by adults aged 18-59. In one study, researchers found no major safety issues, and participants did not report any serious side effects.
The most common reactions were mild, such as soreness at the injection site or temporary fatigue. The vaccine was also found to be as effective as other similar vaccines in boosting the immune system.
Notably, the FDA has already approved the mRNA-1345 vaccine for other uses, suggesting its safety. However, as it is still under study for new applications, ongoing research will continue to monitor its safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the mRNA-1345 vaccine for RSV because it uses mRNA technology, a newer approach that has already shown promise in fighting other viruses like COVID-19. Unlike traditional vaccines that often use weakened or inactive parts of the virus, mRNA-1345 instructs cells to produce a protein that triggers an immune response, potentially enhancing effectiveness and safety. Additionally, this vaccine is being tested in both single and dual-dose regimens, offering flexibility that could lead to more tailored protection strategies against RSV.
What evidence suggests that this trial's treatments could be effective for RSV?
Research has shown that the mRNA-1345 vaccine could help protect adults from RSV, a virus affecting the lungs. In this trial, participants will receive different dosing regimens of the mRNA-1345 vaccine. One study found that a single dose of this vaccine reduced RSV-related lung infections in older adults. It also maintained a strong immune response for up to six months after administration, with no major safety concerns. Receiving another dose after a year continued to provide good protection. These results suggest that mRNA-1345 could effectively prevent RSV infections in high-risk adults, including those who have had organ transplants.46789
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1 for high-risk adults aged ≥18 to <60 years
Treatment Part B
Two injections of mRNA-1345 administered IM on Day 1 and Day 57 for adults who received solid organ transplant (SOT)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1345
mRNA-1345 is already approved in United States for the following indications:
- Prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
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