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RSV Vaccine Study for Transplant Recipients

This study is looking at how long the immune response from the adjuvanted RSVPreF3 vaccine lasts in adults aged 18 and older who have received a lung or kidney transplant. It also checks the safety and immune response after these individuals receive another dose of the vaccine. You may be able to join if you previously participated in the RSV OA=ADJ-023 study and received either one or two doses of the adjuvanted RSVPreF3 vaccine. The main goals are to measure the levels of antibodies (RSV-A and RSV-B neutralizing titers) at the start of this study and to see how much these antibody levels increase after revaccination. The study aims to enroll 184 participants.

Study design
This is an interventional study involving 184 participants who previously received the adjuvanted RSVPreF3 vaccine. Participants will receive an additional dose of the vaccine.
What's involved
Participants will receive one dose of the adjuvanted RSVPreF3 vaccine. Measurements of RSV-A and RSV-B neutralizing titers will be taken at the start of the study.
Compensation
Not stated in the trial record.
Follow-up
Immune responses will be measured at the start of the study and over 30 days post last dose in the previous study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07092865

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalPrevention
GlaxoSmithKline
~168 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Adjuvanted RSVPreF3 vaccine

At a glance

Recruiting sites
0 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)
Measured over At Visit 1 (Day 1) of the current study
+7 more outcomes measured

Conditions

Respiratory Syncytial Virus Infections

Explore related trials

Kidney TransplantationLung Transplantation

Where it's being run

37 sites across 16 states
Spain9
Japan7
Italy5
Queensland2
Ontario2
South Korea2
Kentucky1
Missouri1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.
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.
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 in the opinion of the investigator may put the participant at increased risk.
Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia \> 200 IU/mL.
Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) prior to Visit 1.
Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are non-registered and:
available locally through compassionate use programs,
submitted for and pending local/country registration,
approved and registered for use in other countries with well-documented SmPC or Prescribing Information. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing.
Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies.
Any clinically significant (based on the Investigator's clinical judgement) hematologic (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte mean corpuscular volume) and/or biochemical (ALT, AST, creatinine, blood urea nitrogen) laboratory abnormality.
Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason for a previous allograft loss is not recurrent primary kidney disease.
Evidence of significant proteinuria/albuminuria in the opinion of the investigator.
At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks, based on the following: clinical, radiological, and/or physiological deterioration; OR isolation of an organism from a clinically relevant BAL fluid culture.
Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1.

What this trial measures

  • RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)At Visit 1 (Day 1) of the current study

    RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60). GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  • RSV-B neutralizing titers expressed as GMTsAt Visit 1 (Day 1) of the current study

    RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  • RSV-A neutralizing titers expressed as Mean geometric increase (MGI)At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).

  • RSV-B neutralizing titers expressed as MGIAt Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).

  • RSV-A neutralizing titers expressed as GMTsAt Visit 2 (Day 31) of the current study

    RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  • RSV-B neutralizing titers expressed as GMTsAt Visit 2 (Day 31) of the current study

    RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  • RSV-A neutralizing titers expressed as GMTsAt Visit 3 (Day 180) of the current study

    RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  • RSV-B neutralizing titers expressed as GMTsAt Visit 3 (Day 180) of the current study

    RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.