NCT02561871

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers

Phase 1, First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.

Detailed description

This is a single-center, randomized (study vaccine assigned to participants by chance), placebo-controlled study (an inactive substance; a pretend treatment \[with no vaccine in it\] that is compared in a clinical trial with a vaccine to test if the vaccine has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) Phase 1 study in healthy participants. The study comprises a 4-week screening period; vaccination for each participant on Days 1, 85, and, 169; a 28-day follow-up period performed after each vaccination and a final visit at Day 337. Approximately 32 Participants will be randomized in parallel in a 3:3:2 ratio to 3 treatment groups (Group 1/2/3) to receive either Ad26.RSV.FA2 or Ad35.RSV.FA2 or placebo. The study duration will be approximately 52 weeks. Blood samples for immunogenicity will be collected. Participant's safety will be evaluated throughout the study.

Conditions

• Respiratory Syncytial Viruses
• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.RSV.FA2	Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 in Group 2.
BIOLOGICAL	Ad35.RSV.FA2	Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 85 in Group 2.
DRUG	Placebo	Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-09-28
• Last updated: 2016-11-01

Locations

1 site across 1 country: United States