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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
GlaxoSmithKline
Study ID
NCT07092865
Phase
PHASE2
Status
Recruiting
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Conditions

  • Respiratory Syncytial Virus Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjuvanted RSVPreF3 vaccine — BIOLOGICAL
    1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

Study Details

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.

Key Dates

Start date
Aug 6, 2025
Status verified
Mar 2026
Primary completion
Jan 12, 2027
Completion
Jul 16, 2027

Study Design

Enrollment
184 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: IC Revaccination Group
    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.

Primary Outcome Measure

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) [ Time Frame: At Visit 1 (Day 1) of the current study ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLexingtonKentucky40536
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Richard Greenberg (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSt LouisMissouri63110
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Rachel Presti (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSt LouisMissouri63110
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Tarek Alhamad (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOmahaNebraska68198
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Anum Abbas (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew YorkNew York10065
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Catherine Small (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePittsburghPennsylvania15213
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Fernanda Silveira (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteTempleTexas76502
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Mohanram Narayanan (PRINCIPAL_INVESTIGATOR)

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