mRNA Vaccines for Flu and COVID-19
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new mRNA vaccines for flu and COVID-19 to assess their safety and effectiveness. Different groups will receive various versions of the vaccines to identify the best candidate for future studies. Healthy individuals, fully vaccinated against COVID-19 and without a recent flu shot, might be suitable participants. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
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 on systemic immunosuppressants, you may not be eligible to participate. 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?
Previous studies have shown mRNA-1083 to be safe. Research indicates it generated strong immune responses against the flu and COVID-19. Recipients reported side effects similar to those of other vaccines, such as mild pain at the injection site or fatigue. Serious side effects have been rare.
This clinical trial is in its early stages, focusing on the vaccine's safety and tolerability. At this stage, treatments are generally considered safe, but more information is needed to confirm this for mRNA-1083. Prospective participants should consult a healthcare provider about any concerns before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these mRNA vaccines for flu and COVID-19 because they offer a new way of fighting these viruses by using the same mRNA technology that was groundbreaking in COVID-19 vaccines like Pfizer's and Moderna's. Unlike traditional vaccines, which often use inactivated viruses, these mRNA vaccines work by instructing cells to produce proteins that trigger an immune response, potentially enhancing effectiveness and safety. Additionally, mRNA vaccines can be rapidly updated to target new virus strains, offering a flexible and timely response to evolving pathogens. This adaptability could make mRNA vaccines a powerful tool in managing seasonal flu and potential COVID-19 variants.
What evidence suggests that this trial's treatments could be effective for flu and COVID-19?
Research shows that the mRNA-1083 vaccine, which participants in this trial may receive, creates strong defenses against both COVID-19 and flu viruses. It has produced better immune responses than other flu vaccines in older adults, suggesting high effectiveness. Similarly, the mRNA-1010 vaccine, another option in this trial, has demonstrated strong defenses against seasonal flu strains. It performed well in studies, showing better results than some traditional flu vaccines. For COVID-19, the next-generation mRNA-1273.222 and mRNA-1283.222 vaccines, also part of this trial, have improved immune responses, offering better protection against the virus compared to earlier versions. Overall, these mRNA vaccines show promising potential in fighting both flu and COVID-19.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 65–79 who've completed their initial COVID-19 vaccine series at least 4 months ago and haven't had a flu shot in the last 5 months. Participants must be willing to attend up to 5 visits and take about 4 calls over roughly 7 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular injection of either mRNA-based vaccines or comparator vaccines on Day 1
Follow-up
Participants are monitored for safety, reactogenicity, and immunogenicity, with primary outcome measures assessed at Day 29
Extended Follow-up
Participants are monitored for long-term immunogenicity and safety, with secondary outcome measures assessed at Day 181
What Are the Treatments Tested in This Trial?
Interventions
- Fluarix
- Fluzone HD
- mRNA-1010
- mRNA-1010.4
- mRNA-1083.1
- mRNA-1083.2
- mRNA-1083.3
- mRNA-1273.222
- mRNA-1283.222
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