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

Completed · Phase 2

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID

NCT05921903

Run by

GlaxoSmithKline

People needed

386

Starts

2023-07-28

Expected to finish

2025-05-16

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Santander, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — Seoul, South Korea
• GSK Investigational Site — A Coruña, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Córdoba, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Minneapolis, Minnesota, 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 — 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

Full record on ClinicalTrials.gov

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