NCT00331474

The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Stellenbosch · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

Summary

Background: Each year, more than half a million babies are infected with HIV by mother-to child transmission in developing countries. Many of these babies get sick and develop HIV disease (AIDS) at a very young age. Exposure to other infectious diseases may influence this early progression to AIDS. BCG is a live tuberculosis vaccine made from cow tuberculosis. It is routinely given at birth to most babies, also to babies born to HIV-positive mothers. BCG can cause disease (BCGosis) in HIV-infected babies. More importantly, BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS. Objective(s) and Hypothesis: The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial: babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age. In these 2 groups of babies, the researchers will compare: * The percentage of babies who progress to HIV disease * Blood markers of HIV disease (the amount of virus and protective white blood cells in the body) * The body's immune response to BCG vaccine and other childhood vaccines * The percentage of children who develop BCG scarring, BCG vaccine complications and tuberculosis. Potential Impact: BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries. Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	BCG delayed	early (birth) and delayed (14 weeks) intradermal BCG vaccination

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-12-01
• Completion: 2009-08-01
• First posted: 2006-05-31
• Last updated: 2009-02-16

Locations

1 site across 1 country: South Africa