RSVpreF for Respiratory Syncytial Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of the RSVpreF vaccine for children at high risk for respiratory syncytial virus (RSV), particularly those with weakened immune systems. RSV can lead to serious lung infections, so the study tests the vaccine in different groups: some receive the vaccine once, others twice, and some receive a placebo (inactive substance). Children with conditions such as cystic fibrosis, treated asthma, Down syndrome, or certain heart issues may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the RSVpreF vaccine is generally safe. Designed to protect against respiratory syncytial virus (RSV), it has been well-tolerated by older adults. Some studies noted a slight increase in cases of Guillain-Barré syndrome (GBS), a rare nerve disorder, with about 18.2 extra cases per million doses. However, this risk remains very low.
The RSVpreF vaccine has also been approved for use in other groups, such as seniors and pregnant individuals, indicating a strong safety record. This approval signifies that the vaccine passed numerous safety checks. Most people do not experience serious side effects from this vaccine.12345Why do researchers think this study treatment might be promising?
Most treatments for respiratory syncytial virus (RSV) focus on managing symptoms, but RSVpreF offers a new approach by targeting the virus directly through a protein-based vaccine. RSVpreF works by using a stabilized prefusion form of the RSV F protein, which is crucial in triggering a strong immune response. Unlike existing options that often involve supportive care or antiviral medications, RSVpreF aims to prevent the infection altogether. Researchers are excited about RSVpreF because it has the potential to significantly reduce the incidence of RSV infections, providing long-term protection with possibly just one or two doses.
What evidence suggests that RSVpreF might be an effective treatment for RSV?
Research has shown that the RSVpreF vaccine works well against respiratory syncytial virus (RSV) infections. One study found the vaccine to be 82.6% effective in preventing confirmed RSV lower lung infections. Another study showed it reduced the risk of RSV-related hospital stays by 93.8% in older adults at high risk. In babies, the vaccine was 82.2% effective in preventing hospital visits due to severe RSV. These results suggest that RSVpreF can strongly protect against serious RSV infections. Participants in this trial may receive RSVpreF in different dosing schedules or a placebo to further evaluate its effectiveness and safety.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 children ages 5 to under 18 who are at high risk of getting seriously ill from RSV, including those with weakened immune systems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive a single dose of RSVpreF or placebo at the first study visit
Follow-up
Participants are monitored for adverse events and immune response after initial vaccination
Second Treatment (Cohort 2 only)
Participants in Cohort 2 receive a second dose of RSVpreF or placebo at the 12-month visit
Extended Follow-up
Participants are monitored for safety, adverse events, and immune response up to 24 months after vaccination
What Are the Treatments Tested in This Trial?
Interventions
- RSVpreF
Trial Overview
The study is testing an RSV vaccine called RSVpreF compared to a placebo (inactive shot) in high-risk children. The goal is to see if the vaccine is safe and helps their bodies build protection against RSV.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Cohort 2 (a and b): Participants will receive 1 dose of RSVpreF at the first study visit, and 1 dose of RSVpreF at the 12-month visit.
Cohort 2 (a and b): Participants will receive 1 dose of RSVpreF at the first study visit, and 1 dose of placebo at the 12-month visit.
Cohort 1 (a and b): Participants will receive a single dose of RSVpreF at the first study visit.
Cohort 1 (a and b): Participants will receive a single dose of placebo at the first study visit.
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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
Citations
RSV Vaccine Effectiveness Against Hospitalization Among US ...
Respiratory syncytial virus vaccines were effective against hospitalization with RSV subtype A (54%; 95% CI, 31%-70%) and RSV subtype B (65%; 95 ...
Respiratory Syncytial Virus Prefusion F (RSVPreF3) Vaccine
the immunization achieved an overall efficacy of 82.6% (96.95% CI, 57.9-94.1) against RSV-LRTD confirmed by reverse-transcriptase polymerase
Meta-Analysis Supports RSV Vaccine Efficacy and Safety ...
Across 5 trials involving 101,825 participants, RSV vaccination was associated with a statistically significant reduction in LRTIs compared with ...
4.
researchportal.ukhsa.gov.uk
researchportal.ukhsa.gov.uk/en/publications/effectiveness-of-the-maternal-rsvpref-vaccine-against-severe-dise/Effectiveness of the maternal RSVpreF vaccine against severe ...
Adjusted vaccine effectiveness against RSV-associated LRTI hospital admission was 82·2% (95% CI 75·1–87·3; p<0·0001) in vaccinated infants compared with ...
5.
hmpgloballearningnetwork.com
hmpgloballearningnetwork.com/site/pln/news/clinical-and-economic-projections-rsv-vaccine-effectiveness-older-adultsClinical and Economic Projections for RSV Vaccine ...
Pfizer's RSVpreF would result in a reduction of 22 301 cases, 227 fewer deaths, and lower total medical care costs by $86.0 million.
6.
contagionlive.com
contagionlive.com/view/investigational-rsv-vaccine-for-seniors-demonstrates-efficacy-and-safetyInvestigational RSV Vaccine for Seniors Demonstrates ...
During a late breaking session at ID Week, an investigator presented data on the GSK vaccine that is in development.
Early Safety Findings Among Persons Aged ≥60 Years ...
During August 4, 2023–March 30, 2024, at least 10.6 million adults aged ≥60 years received a recommended RSV vaccine.
8.
bstquarterly.com
bstquarterly.com/article/study-funds-rsv-vaccines-protect-older-adults-with-75-percent-effectiveness/Study Finds RSV Vaccines Protect Older Adults with 75 ...
The RSVPreF vaccine (Abrysvo) was associated with 18.2 excess GBS cases per million doses, while the RSVPreF3+AS01 vaccine (Arexvy) showed a ...
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If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years of age or older.
peer review history
“This study marks the first post-authorization safety analysis of the RSVPreF vaccine among pregnant individuals, utilizing passive ...
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