NCT03334695

An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults

An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\*10\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.RSV.preF	Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp in single-use vials.
DRUG	Placebo	Placebo will be administered as sterile 0.9% saline for injection.

Timeline

• Start date: 2017-10-16
• Primary completion: 2018-07-10
• Completion: 2018-11-27
• First posted: 2017-11-07
• Last updated: 2025-02-04
• Results posted: 2021-07-23

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study