Modified RNA Vaccines for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of new RNA-based flu vaccines. Participants will receive a single dose of either a new modRNA flu vaccine (Influenza ModRNA Vaccine) or a standard flu vaccine. The study seeks generally healthy adults who haven't received a flu shot in the past six months. Participants will be involved for about six months, with at least three clinic visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, mRNA-based vaccines for the flu, similar to the modRNA vaccines being tested, showed safety. These vaccines usually cause only mild side effects like headaches, soreness, and muscle aches. Research shows that these side effects are typically temporary and not serious. Another study found that these vaccines cause fewer and less severe reactions in adults compared to other types of vaccines. This suggests that the modRNA vaccines might be well-tolerated and safe for most people.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the Influenza ModRNA Vaccine because it utilizes modified RNA (ModRNA) technology, which is a significant shift from traditional flu vaccines that typically use inactivated or weakened viruses. This ModRNA approach allows the vaccine to instruct cells to produce a protein similar to the influenza virus, prompting an immune response without using the live virus itself. This method can potentially lead to a faster production process and may offer broader protection against various flu strains. Unlike standard flu vaccines requiring seasonal updates, this innovative technology could streamline vaccine development and enhance adaptability to emerging flu variants.
What evidence suggests that this trial's treatments could be effective for flu?
Research has shown that modified RNA (modRNA) vaccines could effectively prevent the flu. In this trial, participants will receive different versions of the Influenza ModRNA Vaccine. One study demonstrated that a flu vaccine called mRNA-1010 created a strong immune response, particularly against certain types of the influenza A virus. Another study found that these vaccines might trigger a stronger immune response than traditional flu vaccines. Traditional flu vaccines often work less than 60% of the time, but modRNA vaccines aim to improve this rate. These early results suggest that modRNA vaccines could offer better protection against the flu.56789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for generally healthy adults over 18 who haven't had a flu shot in the last 6 months. It's to see if new modRNA vaccines are safe and how they affect the body's defense against flu.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of either a modRNA influenza vaccine or an approved influenza vaccine
Follow-up
Participants are monitored for safety and effectiveness after vaccination, including local and systemic reactions
What Are the Treatments Tested in This Trial?
Interventions
- Influenza ModRNA Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University