NCT02109354

Safety of and Immune Response to Vaccination With 2 Experimental HIV Vaccines in Healthy Adults

Phase 1b Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Vaccine Regimen ALVAC-HIV (vCP1521) Followed by AIDSVAX® B/E in Healthy, HIV-1 Uninfected Adult Participants in South Africa

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines in combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that causes AIDS. Tetanus is an infection that causes muscular spasms. Hepatitis B is a virus that can cause liver failure. About 100 people will take part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. We are doing this study to answer several questions. * Are the HIV study vaccines safe to give to people? * Are people able to take the HIV study vaccines without becoming too uncomfortable? * How do people's immune systems respond to the HIV study vaccines? (Your immune system protects you from disease.) * Can people's immune responses to a tetanus or hepatitis B vaccines help us understand how their immune systems might respond to the HIV study vaccines? * Is there a common immune response to licensed vaccines like the tetanus and hepatitis B vaccines?

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALVAC-HIV	Formulated as a lyophilized vaccine for injection and is reconstituted with 1.05 mL of sterile Sodium Chloride solution (0.4% NaCl) for a single 1 mL dose of \>1.0 x 106 CCID50/mL, to administer intramuscularly (IM).
BIOLOGICAL	AIDSVAX B/E	300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant. Each vial contains 1.2 mL of sterile suspension, to administer 1 mL IM.
BIOLOGICAL	Placebo for ALVAC-HIV	A sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1.05 mL of sterile Sodium Chloride (0.4% NaCl) for a single 1 mL dose, to administer IM.
BIOLOGICAL	Placebo for AIDSVAX B/E	Sodium Chloride for Injection, 0.9% administered IM.
BIOLOGICAL	Hepatitis B vaccine	Each 1 mL dose contains 20 mcg of hepatitis B surface antigen (HBsAg) adsorbed onto 500 mcg aluminum as aluminum hydroxide, to administer IM.
BIOLOGICAL	Tetanus toxoid vaccine	The active ingredient is tetanus toxoid (≥ 40 I.U. / 0.5 mL) adsorbed on aluminium hydroxide dihydrate (600 mcg of aluminium), to administer IM.
BIOLOGICAL	Placebo for hepatitis B vaccine	Sodium Chloride for Injection, 0.9% administered IM.
BIOLOGICAL	Placebo for tetanus vaccine	Sodium Chloride for Injection, 0.9% administered IM.

Timeline

• Start date: 2013-06-18
• Primary completion: 2015-02-02
• Completion: 2015-02-02
• First posted: 2014-04-09
• Last updated: 2019-06-21

Locations

3 sites across 1 country: South Africa