RSV Vaccine for Respiratory Syncytial Virus
(MONET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, RSVpreF, to evaluate its effectiveness in helping the body combat the Respiratory Syncytial Virus (RSV), which can cause serious lung problems. The study consists of two parts: one for adults with certain long-term health conditions like asthma or heart disease, and another for those with weakened immune systems. Participants will receive the vaccine and undergo blood tests to measure their immune response. Individuals with serious lung issues or immune system concerns might be suitable candidates. As a Phase 3 trial, this study represents 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 on certain treatments like high-dose systemic corticosteroids or have received blood products recently, you may not be eligible. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the RSVpreF vaccine, also known as ABRYSVO, is safe. Studies have found that this vaccine helps lower the risk of serious RSV-related illnesses in adults. It has also been safely used in pregnant women, with side effects similar to those observed in earlier studies.
For those considering joining the trial, this indicates that the vaccine is generally well-tolerated. Common side effects might include mild reactions at the injection site or feeling slightly unwell, but serious side effects are rare. Notably, the FDA has already approved RSVpreF for certain uses, which enhances confidence in its safety.12345Why do researchers think this study treatment might be promising for RSV?
Researchers are excited about RSVpreF for respiratory syncytial virus (RSV) because it targets the virus using a stabilized pre-fusion form of the RSV F protein, a crucial part of the virus's structure. This is different from current RSV preventative options like palivizumab, which is a monoclonal antibody primarily used in high-risk infants. RSVpreF offers a potentially broader application as a vaccine and could provide long-lasting immunity with just one or two doses. Moreover, if successful, this vaccine could be a game-changer in preventing RSV infections more widely across different age groups, including older adults.
What evidence suggests that this trial's RSVpreF vaccine could be effective for preventing severe RSV disease?
This trial will evaluate the RSVpreF vaccine for its effectiveness in preventing severe illness caused by the Respiratory Syncytial Virus (RSV). Participants in Substudy A will receive a single 120-µg dose of RSVpreF or a placebo. In Substudy B, participants will receive 120-µg doses of RSVpreF at two visits. Studies have shown that the RSVpreF vaccine is highly effective. Specifically, research indicates that for adults aged 60 and older, the vaccine's effectiveness against serious RSV-related lung infections ranges from 83% to 89%. This significantly lowers the risk of severe RSV illness that might require hospitalization or an emergency room visit. While most data comes from older adults, these findings strongly suggest that the vaccine can protect vulnerable groups from RSV.678910
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 adults at high risk of severe RSV disease, aged 18-60 with chronic health issues like lung or heart conditions, but not those who are immunocompromised. It's also for adults over 18, including those over 60 with weakened immune systems. Participants must be able to consent and commit to the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RSVpreF or placebo (Substudy A) or RSVpreF (Substudy B) with blood samples taken at each visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RSVpreF
RSVpreF is already approved in United States, European Union, Canada, Japan for the following indications:
- Lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
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