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

HIV Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

• NCT number: NCT02366013
• Study type: Interventional
• Source: International AIDS Vaccine Initiative
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Completion date: June 2016