A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Running, not enrolling · Phase 2

Conditions studied: Respiratory Syncytial Virus Infections

In brief

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Key facts

Study ID

NCT07092865

Run by

GlaxoSmithKline

People needed

168

Starts

2025-08-06

Expected to finish

2027-07-16

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC_1 and Visit 4 for participants in IC_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.
• Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).
• Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
• Female participants of nonchildbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
• Female participants of childbearing potential may be enrolled in the study if the participant:
• has practiced adequate contraception from 1 month prior to study intervention administration, and
• agreed to continue adequate contraception until 1 month after study intervention, and
• has a negative pregnancy test on the day of and prior to study intervention administration.
• Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration.
• Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
• Specific inclusion criteria for kidney transplant (KTx) patients
• Participant with stable kidney function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.
• Specific inclusion criteria for lung transplant (LTx) patients • Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.

You may not qualify if…

• Medical conditions
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention
• Acute or chronic clinically significant cardiovascular or hepatic functional abnormality, as determined by physical examination or laboratory screening tests.
• Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
• Any condition which, in the judgment of the investigator, would make IM injection unsafe.
• Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study.
• Prior/Concomitant therapy
• Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the RSV OA=ADJ-023 study.
• Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention administration during the period beginning 30 days before the study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Month 12).
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study intervention administration and ending 30 days after the study intervention administration*. In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after study intervention administration.
• If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by the public health authorities outside the routine immunization program, the time period of 30 days described above can be reduced, if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified.
• Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
• Other exclusion criteria
• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• Any study personnel or their immediate dependents, family, or household members.
• Planned move during the study period that will prohibit participating in the study until study end.
• Pregnant or lactating female participant.
• Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
• More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung).
• History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction.
• Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1.
• Histologic evidence of chronic allograft injury.

Where it is running

• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Temple, Texas, United States
• GSK Investigational Site — Camperdown, New South Wales, Australia
• GSK Investigational Site — Birtinya, Queensland, Australia
• GSK Investigational Site — Herston, Queensland, Australia
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Vancouver, British Columbia, Canada
• GSK Investigational Site — London, Ontario, Canada
• GSK Investigational Site — Toronto, Ontario, Canada
• GSK Investigational Site — Giessen, Germany
• GSK Investigational Site — Milan, Italy
• GSK Investigational Site — Milan, Italy
• GSK Investigational Site — Palermo, Italy
• GSK Investigational Site — Pavia, Italy
• GSK Investigational Site — Siena, Italy
• GSK Investigational Site — Aichi, Japan
• GSK Investigational Site — Aichi, Japan
• GSK Investigational Site — Fukuoka, Japan
• GSK Investigational Site — Hyōgo, Japan
• GSK Investigational Site — Kumamoto, Japan
• GSK Investigational Site — Okayama, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.