NCT07092865

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 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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted RSVPreF3 vaccine	1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

Timeline

• Start date: 2025-08-06
• Primary completion: 2027-01-12
• Completion: 2027-07-16
• First posted: 2025-07-30
• Last updated: 2026-03-06

Locations

37 sites across 8 countries: United States, Australia, Canada, Germany, Italy, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study