NCT03303625

A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age

A Randomized, Double-blind, Phase 1/2a Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.preF in Adults 18 to 50 Years of Age, RSV-seropositive Toddlers 12 to 24 Months of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 12 Months – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Detailed description

The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.

Conditions

• Respiratory Syncytial Viruses
• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.RSV.preF (1*10^11 vp)	Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
BIOLOGICAL	Ad26.RSV.preF (5*10^10 vp)	RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
DRUG	Placebo	Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.

Timeline

• Start date: 2017-11-29
• Primary completion: 2020-04-21
• Completion: 2020-04-21
• First posted: 2017-10-06
• Last updated: 2025-05-25
• Results posted: 2023-06-23

Locations

7 sites across 3 countries: United States, Finland, United Kingdom

Regulatory

• FDA-regulated drug study