NCT05327816

A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.

Detailed description

RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.

Conditions

• Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention

Interventions

Type	Name	Description
BIOLOGICAL	RSV preF-based Vaccine	RSV preF-based vaccine will be administered as intramuscular injection.
DRUG	Placebo	Placebo will be administered as intramuscular injection.

Timeline

• Start date: 2022-04-13
• Primary completion: 2023-01-16
• Completion: 2023-02-14
• First posted: 2022-04-14
• Last updated: 2025-05-25
• Results posted: 2024-01-02

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study