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A Phase 2b, Open-label Extension Study to Evaluate Immune Response Persistence and Safety of Adjuvanted RSVPreF3 Vaccine Revaccination in Lung and Kidney Transplant Recipients
Led by GlaxoSmithKline · Updated on 2026-03-06
184
Participants Needed
37
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate the persistence of immune response and the safety of revaccination with an adjuvanted Respiratory Syncytial Virus (RSV) vaccine in adults aged 18 years and older who have received lung or kidney transplants. Participants are individuals undergoing chronic immunosuppressive therapy who previously received one or two doses of the adjuvanted RSVPreF3 vaccine in a prior study. The study focuses on assessing immune responses separately for those who had one or two initial doses and collectively for safety analysis. Participants will receive an additional dose of the adjuvanted RSVPreF3 vaccine administered by injection into the muscle at the start of this study. The study groups include those who received one dose (IC_1) and those who received two doses (IC_2) in the prior study. Revaccination occurs at the first visit (Day 1), and participants will be monitored through scheduled visits to assess immune response and safety. During the study, participants will have multiple visits at Day 1, Day 31, and Day 180 to measure specific immune markers, including RSV-A and RSV-B neutralizing antibody levels. Safety evaluations include monitoring for side effects and adverse events from the day of revaccination up to one year. Participants will complete diaries and questionnaires, and their health will be regularly assessed to track immune response persistence and any related safety concerns.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of the RSV OA=ADJ-023 study who received 1 or 2 doses of the adjuvanted RSVPreF3 vaccine with available immunogenicity data
- Able and willing to comply with study requirements including follow-up visits and use of phone or electronic communication
- Provided written or witnessed informed consent
- Female participants of non-childbearing potential or females of childbearing potential using adequate contraception and with a negative pregnancy test
- Received an ABO compatible lung or kidney transplant more than 12 months ago
- Receiving maintenance immunosuppressive therapy to prevent allograft rejection
- Kidney transplant patients with stable kidney function as defined by less than 20% variability in eGFR
- Lung transplant patients with stable lung function based on FEV1 and medical history
You will not qualify if you...
- History of dementia or any condition impairing cognition moderately or severely
- Significant underlying illness expected to limit survival or study completion
- History of hypersensitivity to any component of the study vaccine
- Significant cardiovascular or liver abnormalities
- Recurrent or uncontrolled neurological disorders or seizures, except medically controlled chronic neurological diseases assessed by investigator
- Conditions making intramuscular injection unsafe
- Vaccination with RSV-antigen containing vaccine after initial RSV OA=ADJ-023 doses
- Use of investigational or non-registered products within 30 days before study and during study
- Planned or actual vaccination not foreseen by protocol within 30 days before and after study vaccine, except certain exceptions
- Participation in another clinical study involving investigational interventions during study period
- History of chronic alcohol or drug abuse impacting study compliance
- Study personnel or immediate dependents
- Planned move preventing study completion
- Pregnant or lactating females or females planning pregnancy or to stop contraception
- More than one organ transplanted except double kidney or double lung
- History of events increasing risk for chronic allograft dysfunction
- Allograft rejection episode within 3 months before study
- Histologic evidence of chronic allograft injury or active treatment for acute rejection
- Current malignancy except certain skin cancers
- Autoimmune conditions or immune-mediated diseases increasing risk
- Confirmed or suspected HIV, primary immunodeficiency, or ongoing CMV infection with high viremia
- Use of anti-CD20 or B-cell monoclonal antibodies within 9 months before study
- Use of certain non-registered immunosuppressants not approved locally
- Evidence of noncompliance to immunosuppressive therapies
- Significant hematologic or biochemical laboratory abnormalities
- Kidney transplant patients with previous allograft loss due to recurrent kidney disease or significant proteinuria
- Lung transplant patients with recent acute pulmonary infection or chronic lung allograft dysfunction
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive 1 dose of the adjuvanted RSVPreF3 vaccine administered intramuscularly at the start of the study.
1 visit (Day 1, in-person)
Duration - 6 months
Participants are monitored for immune response and safety following revaccination.
2 visits (Day 31 and Day 180, in-person)
Duration - Up to 1 year
Participants are followed for safety, including serious adverse events and immune-mediated diseases.
Follow-up via phone or electronic communication up to Day 365
Trial Site Locations
Total: 37 locations
1
GSK Investigational Site
Lexington, Kentucky, United States, 40536
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2
GSK Investigational Site
St Louis, Missouri, United States, 63110
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3
GSK Investigational Site
St Louis, Missouri, United States, 63110
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4
GSK Investigational Site
Omaha, Nebraska, United States, 68198
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5
GSK Investigational Site
New York, New York, United States, 10065
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6
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
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7
GSK Investigational Site
Temple, Texas, United States, 76502
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8
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
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9
GSK Investigational Site
Birtinya, Queensland, Australia, 4556
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10
GSK Investigational Site
Herston, Queensland, Australia, 4029
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11
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
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12
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
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13
GSK Investigational Site
London, Ontario, Canada, N6A 5A5
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14
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
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15
GSK Investigational Site
Giessen, Germany, 35392
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16
GSK Investigational Site
Milan, Italy, 20122
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17
GSK Investigational Site
Milan, Italy, 20132
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18
GSK Investigational Site
Pavia, Italy, 27100
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19
GSK Investigational Site
Siena, Italy, 53100
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20
GSK Investigational Site
Aichi, Japan, 466-8650
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21
GSK Investigational Site
Aichi, Japan, 470-1192
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22
GSK Investigational Site
Fukuoka, Japan, 814-0180
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23
GSK Investigational Site
Hyōgo, Japan, 662-0918
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24
GSK Investigational Site
Kumamoto, Japan, 861-8520
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25
GSK Investigational Site
Okayama, Japan, 700-8558
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26
GSK Investigational Site
Tokyo, Japan, 193-0998
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27
GSK Investigational Site
Seoul, South Korea, 03722
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28
GSK Investigational Site
Seoul, South Korea, 110-774
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29
GSK Investigational Site
A Coruña, Spain, 15006
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30
GSK Investigational Site
Barcelona, Spain, 8036
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31
GSK Investigational Site
Barcelona, Spain, 8907
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32
GSK Investigational Site
Córdoba, Spain, 14004
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33
GSK Investigational Site
Madrid, Spain, 28007
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34
GSK Investigational Site
Madrid, Spain, 28034
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35
GSK Investigational Site
Madrid, Spain, 28040
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36
GSK Investigational Site
Madrid, Spain, 28041
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37
GSK Investigational Site
Santander, Spain, 39011
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Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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