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.
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
- Type of treatment
- Vaccines, Injection or infusion
- 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
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
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
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
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
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
Australia3 sites
GSK Investigational Site
Birtinya, Queensland, 4556
GSK Investigational Site
Camperdown, New South Wales, 2050
GSK Investigational Site
Herston, Queensland, 4029
South Korea2 sites
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 110-774
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.
- Conditions
- Respiratory Syncytial Virus Infections
- 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 group | Role | What they receive |
|---|---|---|
| IC Revaccination Group | Experimental | Lung 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.
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
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
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
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
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
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
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
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)
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
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
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]
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]
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
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
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
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
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
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
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
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
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.
- First posted30 Jul 2025
- Study start6 Aug 2025
- Primary completion12 Jan 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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