RSV Vaccine for Respiratory Infections
(RSV OA=ADJ-023 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, if you are on investigational or non-registered products, you should not have used them 30 days before the trial starts. Also, if you are on certain immune-modifying drugs, you may need to stop them up to 3 to 6 months before the trial.
What data supports the effectiveness of the RSVPreF3 OA investigational vaccine treatment for respiratory infections?
The RSVPreF3 OA vaccine has shown effectiveness in older adults, particularly those with existing health conditions, by reducing the risk of severe respiratory illness caused by RSV. Studies have demonstrated that the vaccine is well-tolerated and boosts immune responses, making it a promising option for preventing RSV-related diseases.12345
How is the RSVPreF3 OA investigational vaccine different from other treatments for respiratory infections?
The RSVPreF3 OA investigational vaccine is unique because it uses a stabilized prefusion conformation of the RSV fusion protein, which is designed to elicit a stronger immune response, especially in older adults. It is also adjuvanted with AS01E to enhance its effectiveness, particularly for those with weakened immune systems.12346
What is the purpose of this trial?
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
Eligibility Criteria
Adults aged 50 or older who have had a lung or kidney transplant and are on immunosuppressive therapy can join this trial. It's also open to healthy adults over 50. Participants should be able to follow the study plan, not be pregnant, and use contraception if of childbearing potential. Exclusions include severe illnesses that could interfere with the study, recent organ rejection, certain infections like HIV or CMV, multiple organ transplants (except double kidney/lung), and unstable chronic diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 or 2 doses of the RSVPreF3 OA investigational vaccine
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- RSVPreF3 OA Investigational Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead 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