NCT01264445

Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines

A Phase I Double-blinded, Placebo-controlled, Randomized Trial in HIV-uninfected, Healthy Adult Volunteers to Evaluate the Safety and Immunogenicity of an Adjuvanted GSK HIV Vaccine Administered With Ad35-GRIN Investigational Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.

Detailed description

Volunteers will be screened up to 42 days before vaccination (up to 90 days for Ad35 neutralizing antibody) and will be followed for 12 months after the last vaccination (16 months total participation). It is estimated that it will take approximately 5 months to complete enrolment.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted GSK investigational HIV vaccine formulation 1	Receive at Months 0 and 1
BIOLOGICAL	Adjuvanted GSK investigational HIV vaccine formulation 2	Receive at Months 0 and 1
BIOLOGICAL	Ad35 investigational HIV vaccine	Receive at Month 0
BIOLOGICAL	Adjuvanted GSK investigational HIV vaccine formulation 2	Receive at Months 3 and 4
BIOLOGICAL	Adjuvanted GSK investigational HIV vaccine formulation 2	Receive at Months 0, 1, and 4
BIOLOGICAL	Ad35 investigational HIV vaccine	Receive at Month 4
BIOLOGICAL	Ad35 investigational HIV vaccine	Receive at Months 0, 1, and 4
BIOLOGICAL	Placebo (saline)	(Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-12-21
• Last updated: 2013-02-11

Locations

4 sites across 3 countries: Kenya, Uganda, Zambia