mRNA Vaccines for Norovirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test new mRNA vaccines for safety and effectiveness in protecting against norovirus, a common virus causing stomach issues. Participants will receive varying doses of the vaccines, mRNA-1403 or mRNA-1405, or a placebo for comparison. The trial is open to healthy adults without a history of serious vaccine reactions or immune system conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapies, you may not be eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that mRNA-1403 is generally safe and well-tolerated. In earlier studies, participants did not experience major safety issues, and the treatment was accepted without significant problems. While less safety information exists for mRNA-1405, early results suggest it is also well-tolerated.
Both mRNA-1403 and mRNA-1405 are being tested for their ability to trigger an immune response, indicating that the body is responding correctly to the treatment. Since the trials are in the early stages, less is known about long-term effects, but serious safety concerns are less likely to have been reported.
These findings come from earlier studies. New data from ongoing trials will provide more information about safety. This trial is an important step in understanding how these treatments work in people.12345Why are researchers excited about this trial's treatments?
Unlike traditional treatments for norovirus, which typically focus on managing symptoms like dehydration and nausea, the mRNA vaccines mRNA-1403 and mRNA-1405 offer a proactive approach by aiming to prevent infection altogether. These vaccines utilize mRNA technology, which teaches the body to recognize and fight the virus by producing a harmless piece of the virus's protein. This is a novel mechanism compared to the standard of care, which lacks specific antiviral treatments for norovirus. Researchers are excited because mRNA vaccines can potentially provide targeted immunity and be developed more rapidly than traditional vaccines, offering a promising new way to combat norovirus outbreaks.
What evidence suggests that this trial's treatments could be effective for norovirus?
Research shows that mRNA-1403 and mRNA-1405 are being developed as vaccines to prevent norovirus, a common cause of stomach flu. In this trial, participants will receive either mRNA-1403 or mRNA-1405 at various dose levels to evaluate their safety and effectiveness. Studies have found that mRNA-1403 is generally safe and helps the immune system fight norovirus. Early results also indicate that it is well-tolerated, meaning it doesn’t cause serious side effects. Meanwhile, mRNA-1405 is being developed to prevent stomach problems caused by norovirus. The mRNA technology used in these vaccines has succeeded in other vaccines, suggesting these could work well too.12678
Are You a Good Fit for This Trial?
Healthy adults aged 18-49 and 60-80 with a BMI of 18-39 kg/m^2 can join. Women must not be pregnant or breastfeeding and using effective contraception. Exclusions include bleeding disorders, acute illness, unstable medical conditions, immunosuppression, history of myocarditis/pericarditis, recent other vaccines or blood donations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive mRNA-1403 or mRNA-1405 at various dose levels to evaluate safety, reactogenicity, and immunogenicity
Phase 2 Treatment
Participants receive mRNA-1403 at various dose levels to evaluate safety, reactogenicity, and immunogenicity
Booster Extension (optional)
Participants may receive a booster dose of mRNA-1403 or placebo 12-15 months after the first dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1403
- mRNA-1405
- Placebo
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