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Virus Therapy

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

Phase 2

Recruiting

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

RSV OA=ADJ-023 Trial 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.Check my eligibility

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.See study design

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.

RSV OA=ADJ-023 Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

RSV OA=ADJ-023 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,441 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ultimate goals do researchers anticipate from this experiment?

"The primary result of this study, to be evaluated in comparison between Visits 3 and 4 (30-42 days after Visit 3), is the RSV-B serum neutralizing titers expressed as MGI post Dose 2 over Post Dose 1. Secondary objectives include evaluation of the geometric mean titers at Visits 2,3,4,5 and 6; cell mediated immunity response in a subset of participants with renal/lung SOT or healthy individuals; and overall percentage of patients experiencing pain, redness or swelling at injection site due to solicited administration events."

Answered by AI

Has FDA granted clearance to RSV_IC_1 group?

"Our team at Power believes that RSV_IC_1's safety is relatively assured, as the Phase 2 trial has yielded promising results in regards to its security. Nevertheless, no efficacy data exists yet."

Answered by AI

Is recruitment still open for this clinical trial?

"This medical trial, which originally went live on July 31st 2023 and was last updated June 16th, is no longer actively recruiting patients. However, data hosted by clinicaltrials.gov reveals that there are currently 31 other trials in need of participants."

Answered by AI

How many locations are hosting the research project?

"Currently, 43 medical centres are accepting qualified participants for this trial. These locations span from Chicago and Iowa City to Lexington and beyond; it is advisable that you pick the closest one in order to reduce travel requirements if accepted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

2023. "A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05921903.

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