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New RSV vaccine shows promise for transplant patients

NCT ID NCT05921903

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental RSV vaccine in adults who had a lung or kidney transplant, as well as in healthy adults over 50. The goal was to see if the vaccine could safely boost their immune response against RSV, a common and potentially serious respiratory virus. Researchers compared giving one dose versus two doses to transplant recipients to find the best approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

386 people

The number who actually took part.

Started

Jul 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living. * Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) 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 study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration. Specific inclusion criteria for renal/lung transplant patients: * A male or female, \>=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF). * Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent. * Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration. * Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. Specific inclusion criteria for renal transplant (RTx) patients: • Participant with stable renal 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. Specific inclusion criteria for healthy participants: * A male or female, \>=50 YoA at the time of signing the ICF. * Healthy participants as established by medical history and clinical examination before entering the study. * Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. * Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: Medical conditions: * History of any reaction/ 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/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed. * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Any condition which would make IM injection unsafe. * Significant underlying illness that would prevent completion of the study). * Acute disease and/or fever at the time of study intervention administration (\>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator. * Bedridden participants. Prior/Concomitant therapy: * Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6). * Previous vaccination with the study antigen (RSV), including investigational RSV vaccines. * Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days. Prior/Concurrent clinical study experience: • Concurrently participating in another active clinical study Other exclusion criteria: * Pregnant or lactating female participant. * Female participant planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse * Participation of any study personnel or their immediate dependents. * Planned move during the study period that will prohibit participating in the study until study end. Specific exclusion criteria for renal/lung transplant patients: * More than one organ transplanted. Dual organ is allowed. * History of events that may put the participant at increased risk for chronic allograft dysfunction. * Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration. * Histologic evidence of chronic allograft injury. * Active treatment for acute rejection. * Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy). * Any autoimmune conditions or pIMDs that may put the participant at increased risk. * Any confirmed or suspected HIV infection, primary immunodeficiency disease or ongoing CMV infection with a viremia \>200 IU/mL. * Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 274 days of first dose of study. * Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available. * Evidence/high suspicion\\ of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies. * Any clinically significant hematologic and/or biochemical laboratory abnormality. Specific exclusion criteria for RTx patients: * Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease. * Evidence of significant proteinuria/albuminuria. Specific exclusion criteria for LTx patients: * At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks. * Patients with diagnosis of chronic lung allograft dysfunction (decrement of \>=20% in FEV1 compared to post-transplant baseline FEV1). Specific exclusion criteria for healthy participants: * Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. * Unstable serious chronic illness. * Chronic administration of immune-modifying drugs (\>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study. * Up to 3 months prior to the study intervention administration: * For corticosteroids -prednisone equivalent ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives. * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus infections

Contacts and locations

Locations

  • GSK Investigational Site

    Phoenix, Arizona, 85013, United States

  • GSK Investigational Site

    Chicago, Illinois, 60612, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40536, United States

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455, United States

  • GSK Investigational Site

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68198-2456, United States

  • GSK Investigational Site

    New York, New York, 10032, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213, United States

  • GSK Investigational Site

    Temple, Texas, 76502, United States

  • GSK Investigational Site

    Camperdown, New South Wales, 2050, Australia

  • GSK Investigational Site

    Birtinya, Queensland, 4556, Australia

  • GSK Investigational Site

    Herston, Queensland, 4029, Australia

  • GSK Investigational Site

    Adelaide, South Australia, 5000, Australia

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7, Canada

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • GSK Investigational Site

    London, Ontario, N6A 5A5, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2, Canada

  • GSK Investigational Site

    Giessen, 35392, Germany

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Pavia, 27100, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Aichi, 466-8650, Japan

  • GSK Investigational Site

    Aichi, 470-1192, Japan

  • GSK Investigational Site

    Fukuoka, 814-0180, Japan

  • GSK Investigational Site

    Hyōgo, 662-0918, Japan

  • GSK Investigational Site

    Kumamoto, 861-8520, Japan

  • GSK Investigational Site

    Okayama, 700-8558, Japan

  • GSK Investigational Site

    Tokyo, 160-0017, Japan

  • GSK Investigational Site

    Tokyo, 193-0998, Japan

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Seoul, 110-774, South Korea

  • GSK Investigational Site

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    A Coruña, 15006, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Córdoba, 14004, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Santander, 39011, Spain

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