NCT02366013

Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine

A Phase 1 Clinical Trial of the Safety and Immunogenicity of an Oral, Replicating Adenovirus 26 Vector Vaccine for HIV-1 (rcAd26.MOS1.HIV-Env) in Healthy HIV-1-uninfected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1 vaccine.

Detailed description

This study is a phase I dose-escalation randomized, double blind, placebo-controlled study designed to evaluate the safety and immunogenicity of rcAd26.MOS1.HIV-Env, an oral replicating adenovirus 26 vector vaccine in healthy HIV-1 uninfected adults. The vaccine will be administered orally at a single time point (Day 0) at one of four dose levels depending on study group: 1 x 10\^8 virus particles (vp), 1 x 10\^9 vp, 1 x 10\^10 vp and 1 x 10\^11 vp. Volunteers will be randomized to vaccine: placebo in a 5:1 ratio in each group. Volunteers will be screened up to 56 days before vaccination and will be followed for 12 months after vaccination. Because the vaccine is replication competent, volunteers will be housed in an isolation unit from day -2 through day 9. Household contacts will also be enrolled and tested for possible transmission.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	rcAd26.MOS1.HIV-Env 1x10^8 vp	1 oral capsule, 1x10\^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
BIOLOGICAL	rcAd26.MOS1.HIV-Env 1x10^9 vp	10 oral capsules, 1x10\^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
BIOLOGICAL	rcAd26.MOS1.HIV-Env 1x10^10 vp	1 oral capsule, 1x10\^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
BIOLOGICAL	rcAd26.MOS1.HIV-Env 1x10^11 vp	10 oral capsules, 1x10\^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-02-19
• Last updated: 2016-11-21

Locations

1 site across 1 country: United States