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

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

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.

Sponsors & Collaborators

• HIV Vaccine Trials Network

  lead NETWORK

Principal Investigators

• Glenda Gray, MD · Perinatal HIV Research Unit

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-06-18

Primary Completion

2015-02-02

Completion

2015-02-02

Countries

• South Africa

Study Locations