Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2026-03-06
184
Participants Needed
37
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 from the RSV OA=ADJ-023 study who received 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and have immunogenicity data available
- Ability and willingness to comply with study requirements, including follow-up visits and communication
- Provided written or witnessed informed consent before any study procedures
- Female participants of nonchildbearing potential (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or post-menopause) can participate
- Female participants of childbearing potential must use adequate contraception from 1 month before to 1 month after vaccination and have a negative pregnancy test on vaccination day
- Received an ABO compatible lung or kidney transplant more than 12 months prior to vaccination
- Receiving maintenance immunosuppressive therapy to prevent organ rejection
- Kidney transplant patients must have stable kidney function with less than 20% variability in eGFR or as assessed by the investigator
- Lung transplant patients must have stable lung function based on FEV1 and medical history over the past 3 months as assessed by the investigator
You will not qualify if you...
- History of dementia or medical conditions severely affecting cognition
- Serious illness expected to prevent study completion or limit survival
- History of reactions or allergies to any vaccine component
- Significant heart or liver problems based on exam or lab tests
- Recurrent or uncontrolled neurological disorders or seizures (controlled chronic neurological diseases may be allowed)
- Any condition making intramuscular injection unsafe
- Other clinical conditions posing additional risk due to study participation
- Vaccination with any RSV-containing vaccine after prior study doses
- Use of investigational or non-registered products within 30 days before or during the study
- Planned or actual administration of vaccines not in the study protocol within 30 days before or after study vaccination (with some exceptions for COVID-19 and influenza vaccines)
- Participation in another clinical study involving investigational or non-investigational interventions during this study
- History of chronic alcohol use or drug abuse affecting safety reporting or compliance
- Study personnel or their immediate family members
- Planned move during the study that prevents study completion
- Pregnant or lactating females or those planning pregnancy or to stop contraception
- More than one organ transplant except dual kidney or dual lung transplants
- History of events increasing risk of chronic allograft dysfunction
- Allograft rejection within 3 months prior to study start
- Evidence of chronic allograft injury or current acute rejection treatment
- Current cancer diagnosis except non-melanoma skin cancer not needing systemic therapy
- Autoimmune or primary immunodeficiency diseases posing increased risk
- Confirmed or suspected HIV infection, primary immunodeficiency, or ongoing high-level CMV infection
- Use of anti-CD20 or B-cell monoclonal antibodies within 9 months prior to study
- Use of certain investigational or non-registered immunosuppressants unless locally approved and documented
- Evidence or suspicion of noncompliance with immunosuppressive therapy
- Significant blood or biochemical lab abnormalities
- For kidney transplant patients: prior allograft loss due to recurrent kidney disease or significant proteinuria
- For lung transplant patients: recent acute pulmonary infection or chronic lung allograft dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
GSK Investigational Site
Lexington, Kentucky, United States, 40536
Actively Recruiting
2
GSK Investigational Site
St Louis, Missouri, United States, 63110
Actively Recruiting
3
GSK Investigational Site
St Louis, Missouri, United States, 63110
Actively Recruiting
4
GSK Investigational Site
Omaha, Nebraska, United States, 68198
Actively Recruiting
5
GSK Investigational Site
New York, New York, United States, 10065
Actively Recruiting
6
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
GSK Investigational Site
Temple, Texas, United States, 76502
Actively Recruiting
8
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
9
GSK Investigational Site
Birtinya, Queensland, Australia, 4556
Actively Recruiting
10
GSK Investigational Site
Herston, Queensland, Australia, 4029
Actively Recruiting
11
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
12
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
13
GSK Investigational Site
London, Ontario, Canada, N6A 5A5
Actively Recruiting
14
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
15
GSK Investigational Site
Giessen, Germany, 35392
Actively Recruiting
16
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
17
GSK Investigational Site
Milan, Italy, 20132
Actively Recruiting
18
GSK Investigational Site
Pavia, Italy, 27100
Actively Recruiting
19
GSK Investigational Site
Siena, Italy, 53100
Actively Recruiting
20
GSK Investigational Site
Aichi, Japan, 466-8650
Actively Recruiting
21
GSK Investigational Site
Aichi, Japan, 470-1192
Actively Recruiting
22
GSK Investigational Site
Fukuoka, Japan, 814-0180
Actively Recruiting
23
GSK Investigational Site
Hyōgo, Japan, 662-0918
Actively Recruiting
24
GSK Investigational Site
Kumamoto, Japan, 861-8520
Actively Recruiting
25
GSK Investigational Site
Okayama, Japan, 700-8558
Actively Recruiting
26
GSK Investigational Site
Tokyo, Japan, 193-0998
Actively Recruiting
27
GSK Investigational Site
Seoul, South Korea, 03722
Actively Recruiting
28
GSK Investigational Site
Seoul, South Korea, 110-774
Actively Recruiting
29
GSK Investigational Site
A Coruña, Spain, 15006
Actively Recruiting
30
GSK Investigational Site
Barcelona, Spain, 8036
Actively Recruiting
31
GSK Investigational Site
Barcelona, Spain, 8907
Actively Recruiting
32
GSK Investigational Site
Córdoba, Spain, 14004
Actively Recruiting
33
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
34
GSK Investigational Site
Madrid, Spain, 28034
Actively Recruiting
35
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
36
GSK Investigational Site
Madrid, Spain, 28041
Actively Recruiting
37
GSK Investigational Site
Santander, Spain, 39011
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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