NCT01215149

Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults

A Phase 1 Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Safety and Immunogenicity of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.

Detailed description

The study is a randomized, double-blind placebo-controlled trial assessing the order of vector priming and boosting (Ad26 versus Ad35), the timing of boost (3 versus 6 months) and the homologous versus heterologous regimen at the 3-month time interval. Groups A-D will be enrolled in Boston, MA, USA, Groups E-H will be enrolled at the East African Clinical Research Centres and Groups I-L will be enrolled at the South African Clinical Research Centres. Volunteers will be screened up to 56 days before vaccination and will be followed for 12 months after the second vaccination. Approximately 212 volunteers will be randomized to receive either vaccine or placebo within a group (A-L); Groups A-D, Groups E-H and Groups I-L will be randomized separately. Up to 7% over-enrolment (approximately 15 volunteers) will be allowed to facilitate enrolment.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Ad35-ENV vaccine	Recombinant adenovirus serotype 35 vector vaccine 5x10\^10 vp, delivered IM
BIOLOGICAL	Ad26.ENVA.01 vaccine	Recombinant adenovirus serotype 26 vector vaccine, 5x10\^10 vp delivered IM
BIOLOGICAL	Placebo Control	Colorless 10mm Tris/HCl buffer

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-10-06
• Last updated: 2012-12-17

Locations

6 sites across 4 countries: United States, Kenya, Rwanda, South Africa