RSV Vaccine for Respiratory Infections (RSV OA=ADJ-023 Trial)

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 (dose 1), at visit 2 (7-14 days post-dose 1), visit 3 (30-60 days post dose-1, dose 2 for the rsv_ic_2 group), visit 4 (visit 3+30-42 days), visit 5 (180-210 days post last-dose) and at visit 6 (350-380 days post last dose)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies an RSV vaccine to prevent severe respiratory infections in immunocompromised people. It will assess whether a second dose boosts the immune response.

Who is the study for?

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.

What is being tested?

The RSVPreF3 OA investigational vaccine is being tested for its effectiveness in triggering an immune response against Respiratory Syncytial Virus (RSV) in those with weakened immune systems due to lung or kidney transplants compared to healthy adults. The study will assess safety and whether a second dose improves immunity.

What are the potential side effects?

Possible side effects from the RSV vaccine may include typical reactions at the injection site such as pain and swelling, general symptoms like fever or fatigue, allergic responses to components of the vaccine, and potentially other unknown risks due to compromised immunity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 (dose 1), at visit 2 (7-14 days post-dose 1), visit 3 (30-60 days post dose-1, dose 2 for the rsv_ic_2 group), visit 4 (visit 3+30-42 days), visit 5 (180-210 days post last-dose) and at visit 6 (350-380 days post last dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 (dose 1), at visit 2 (7-14 days post-dose 1), visit 3 (30-60 days post dose-1, dose 2 for the rsv_ic_2 group), visit 4 (visit 3+30-42 days), visit 5 (180-210 days post last-dose) and at visit 6 (350-380 days post last dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 (dose 1), at visit 2 (7-14 days post-dose 1), visit 3 (30-60 days post dose-1, dose 2 for the rsv_ic_2 group), visit 4 (visit 3+30-42 days), visit 5 (180-210 days post last-dose) and at visit 6 (350-380 days post last dose) for reporting.