NCT02440035

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 homologous and heterologous prime-boost regimens of Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) and Ad26.RSV.FA2 in healthy participants.

Detailed description

This is a single-center, randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), double-blind (neither the researchers nor the participants know what treatment the participant is receiving) and 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 323 or 351. Participants will be randomly assigned to one of the 4 treatment groups (Group 1/2/3/4) to receive either Ad35.RSV.FA2 or Ad26.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

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	Ad35.RSV.FA2	Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 in Group 3.
BIOLOGICAL	Ad26.RSV.FA2	Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 4.
DRUG	Placebo	Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.

Timeline

• Start date: 2015-04-21
• Primary completion: 2016-06-09
• Completion: 2016-06-09
• First posted: 2015-05-12
• Last updated: 2017-08-22

Locations

1 site across 1 country: United States