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

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

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

I have a stable chronic condition like diabetes or heart disease.

I am a woman who cannot become pregnant due to surgery or menopause.

I live independently or in a place with minimal help and can take care of myself.

See 12 more

Exclusion Criteria

I do not have a fever or serious illness right now.

I am currently being treated for a recent organ rejection.

I have not taken high doses of steroids, except for inhaled, topical, or joint injections, in the last 3 months.

See 36 more

Treatment Details

Interventions

RSVPreF3 OA Investigational Vaccine (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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 Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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