RSVPreF3 Vaccine for Respiratory Syncytial Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of the Arexvy vaccine in preventing respiratory syncytial virus (RSV) in individuals with weakened immune systems. The researchers aim to determine whether one or two doses are more effective and to identify potential side effects. Participants will receive three vaccine doses over a year and will be monitored through follow-up visits and phone calls over 1.5 years. Individuals who have had a stem cell or organ transplant or are healthy but at higher risk for RSV may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain vaccines or treatments within specific time frames before the study starts. It's best to discuss your current medications with the study team to get a clear answer.
Is there any evidence suggesting that Arexvy is likely to be safe for humans?
Research has shown that Arexvy, a vaccine for respiratory syncytial virus (RSV), has a good safety record from earlier studies. In a large study with older adults, most participants experienced mild to moderate side effects, such as soreness at the injection site lasting 2-3 days. Some also reported fatigue or headaches, which typically resolved within 1-2 days.
Although long-term safety data is not yet available due to Arexvy being a newer vaccine, these early results are encouraging. The vaccine has been approved for older adults, indicating it has met certain safety standards for that group. Participants in the current trial will receive close monitoring, with regular check-ups to observe any health changes after vaccination.12345Why are researchers excited about this study treatment for RSV?
Researchers are excited about Arexvy for respiratory syncytial virus (RSV) because it offers a new approach to boosting the immune response. Unlike current options such as supportive care or monoclonal antibodies, Arexvy is a vaccine that uses an adjuvanted RSVPreF3 protein to enhance immunity. This means it has the potential to provide longer-lasting protection against RSV. Additionally, the trial explores different dosing schedules, which could optimize its effectiveness and convenience for patients. This innovative approach could significantly reduce the burden of RSV, especially in vulnerable populations.
What evidence suggests that Arexvy might be an effective treatment for RSV in people with weakened immune systems?
Research has shown that Arexvy, a vaccine for respiratory syncytial virus (RSV), works well. It reduced the risk of serious lung problems from RSV by 77.5%. Another study found the vaccine to be 92% effective in preventing RSV-related illnesses that required emergency room visits. These results are encouraging, especially for people with weakened immune systems. In this trial, participants will receive different regimens of Arexvy, with some receiving Arexvy and a placebo, and others receiving multiple doses of Arexvy, to evaluate its effectiveness across various RSV seasons. Overall, Arexvy has provided strong protection during different RSV seasons.678910
Who Is on the Research Team?
John Baddley, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for people with weakened immune systems who want to test a vaccine called Arexvy against RSV. Participants will receive up to 3 doses of the vaccine or a placebo, keep symptom diaries, and attend several follow-up visits over 1.5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive 3 doses of Arexvy over the course of 1 year, with the second dose administered 60 days after the first, and the third dose 1 year after the first dose
Symptom Monitoring
Participants keep a diary of symptoms for 7 days after each vaccine dose
Follow-up
Participants have 3 in-person follow-up visits and 6 phone follow-up visits for checkups and tests over the course of 1.5 years
What Are the Treatments Tested in This Trial?
Interventions
- Arexvy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School