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Respiratory Syncytial Virus InfectionsPhase 2NCT07092865

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

A Phase 2 study testing Adjuvanted RSVPreF3 vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 38 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
Adjuvanted RSVPreF3 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
38 sitesin 8 countries
Study dates
6 Aug 2025to 16 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Specific exclusion criteria for KTx patients:
  • 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.
  • Specific exclusion criteria for LTx patients:
  • 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.

Trial locations and contacts

38 sites in 8 countries.

38 sites in 8 countries

Spain9 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 8036

  • GSK Investigational Site

    Barcelona, 8907

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Santander, 39011

Other trials in Spain

United States7 sites

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    St Louis, Missouri, 63110-1035

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Temple, Texas, 76502

Other trials in United States

Japan7 sites

  • GSK Investigational Site

    Aichi, 466-8650

  • GSK Investigational Site

    Aichi, 470-1192

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Hyōgo, 663-8241

  • GSK Investigational Site

    Kumamoto, 861-8520

  • GSK Investigational Site

    Okayama, 700-8558

  • GSK Investigational Site

    Tokyo, 193-0998

Other trials in Japan

Italy5 sites

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Pavia, 27100

  • GSK Investigational Site

    Siena, 53100

Other trials in Italy

Canada4 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Australia3 sites

  • GSK Investigational Site

    Birtinya, Queensland, 4556

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Herston, Queensland, 4029

Other trials in Australia

South Korea2 sites

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Seoul, 110-774

Other trials in South Korea

Germany1 site

  • GSK Investigational Site

    Giessen, 35392

Other trials in Germany

About this study

Official title: A Phase 2b, Non-randomized, Controlled, Open-label, Extension Study to Evaluate the Persistence of Immune Response of the Adjuvanted RSVPreF3 Vaccine and the Safety and Immunogenicity Following Revaccination in Lung and Kidney Transplant Recipients (>=18 Years of Age)

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.

Read the detailed description

Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy, who received 1 (IC_1 group) and 2 (IC_2 group) doses of the adjuvanted RSVPreF3 vaccine in the RSV OA=ADJ-023 study [parent study; NCT05921903], will receive an additional dose of the adjuvanted RSVPreF3 vaccine in the current study. As pre-assigned in protocol, the participants that received 1 dose and 2 doses of adjuvanted RSVPreF3 vaccine in the parent study will be analysed separately in the current study for the immune response analyses, and under an overall group (IC Revaccination group) for the demographic and safety analyses.

Being tested
Adjuvanted RSVPreF3 vaccine
Keywords
Respiratory Syncytial Virus (RSV), Adjuvated RSVPreF3 vaccine, Solid organ transplant (SOT), Kidney SOT, Lung SOT, Immunocompromised (IC) patients, Humoral immune response, Safety, Reactogenicity
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvanted RSVPreF3 vaccineBiological

    1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

Study groups in NCT07092865
Study groupRoleWhat they receive
IC Revaccination GroupExperimentalLung or kidney transplant recipients undergoing chronic immunosuppressive therapy who received 1 and 2 doses of the adjuvanted RSVPreF3 vaccine (IC_1 and IC_2 groups respectively) in the RSV OA=ADJ-023 parent study will receive a revaccination dose of adjuvanted RSVPreF3 vaccine at Visit 1 (Day 1) in the current study.
Receives: Biological: Adjuvanted RSVPreF3 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)

    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.

    Measured: At Visit 1 (Day 1) of the current study

  2. RSV-B neutralizing titers expressed as GMTs

    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.

    Measured: At Visit 1 (Day 1) of the current study

  3. RSV-A neutralizing titers expressed as Mean geometric increase (MGI)

    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).

    Measured: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

  4. RSV-B neutralizing titers expressed as MGI

    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).

    Measured: At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

  5. RSV-A neutralizing titers expressed as GMTs

    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.

    Measured: At Visit 2 (Day 31) of the current study

  6. RSV-B neutralizing titers expressed as GMTs

    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.

    Measured: At Visit 2 (Day 31) of the current study

  7. RSV-A neutralizing titers expressed as GMTs

    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.

    Measured: At Visit 3 (Day 180) of the current study

  8. RSV-B neutralizing titers expressed as GMTs

    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.

    Measured: At Visit 3 (Day 180) of the current study

Secondary outcomes (13)

  1. GMT ratio of RSV-A neutralizing titers

    RSV-A 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.

    Measured: At Visit 1 (Day 1) of the current study

  2. GMT ratio of RSV-B neutralizing titers

    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.

    Measured: At Visit 1 (Day 1) of the current study

  3. RSV-A neutralizing titers expressed as MGI

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).

    Measured: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]

  4. RSV-B neutralizing titers expressed as MGI

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at Visit 1, and Visit 3 over Visit 1).

    Measured: At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]

  5. RSV-A neutralizing titers expressed as MGI

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).

    Measured: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

  6. RSV-B neutralizing titers expressed as MGI

    MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 2 over titers observed at 30 days post last dose in the RSV OA=ADJ-023 parent study).

    Measured: At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

  7. Number of participants reporting each solicited administration site event

    Solicited administration site events assessed are pain, redness and swelling.

    Measured: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study

  8. Number of participants reporting each solicited systemic event

    Solicited systemic events assessed are fever, headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).

    Measured: Visit 1 (Day 1 [day of revaccination]) to Day 7 of the current study

  9. Number of participants reporting unsolicited adverse events (AEs)

    An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.

    Measured: Visit 1 (Day 1 [day of revaccination]) to Day 30 of the current study

  10. Number of participants reporting any serious adverse events (SAEs)

    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of relation to study vaccination.

    Measured: Visit 1 (Day 1 [day of revaccination] to Visit 3 (Day 180) of the current study

  11. Number of participants reporting related SAEs and fatal SAEs

    Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.

    Measured: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study

  12. Number of participants reporting any Potential immune-mediated disease (pIMDs) and related pIMDs

    pIMDs are a subset of Adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.

    Measured: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study

  13. Number of participants reporting AESIs specific to kidney and lung SOT patients

    AESIs specific to kidney and lung SOT patients include signs of transplant/allograft rejection.

    Measured: Visit 1 (Day 1 [day of revaccination] to study end (Day 365) of the current study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start6 Aug 2025
  3. Primary completion12 Jan 2027 (estimated)
  4. Study completion16 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092865
Sponsor's protocol ID
224083
Other IDs
2024-519730-23-00
Status last verified
Sep 2026
First submitted
23 Jul 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adjuvanted RSVPreF3 vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 38 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Spain, United States, Japan, Italy, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) (time frame: At Visit 1 (Day 1) of the current study). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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