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Virus Therapy

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

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RSV-A serum neutralizing titers expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1
RSV-B serum neutralizing titers expressed as MGI post-Dose 2 over post-Dose 1
Secondary study objectives
Cell Mediated Immunity (CMI) response in a subset of participants
Percentage of participants with any AESIs
Percentage of participants with any potential immune-mediated disease (pIMDs) after study intervention and pIMDs related to study intervention
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: RSV_IC_2 groupExperimental Treatment1 Intervention
Immunocompromised (IC) patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
Group II: RSV_IC_1 groupExperimental Treatment1 Intervention
Immunocompromised (IC) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Group III: RSV_HA groupActive Control1 Intervention
Healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,420 Total Patients Enrolled

Media Library

Respiratory Syncytial Virus Clinical Trial 2023: RSVPreF3 OA Investigational Vaccine Highlights & Side Effects. Trial Name: NCT05921903 — Phase 2
RSVPreF3 OA Investigational Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05921903 — Phase 2
~186 spots leftby Sep 2025
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