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

Stellenbosch University (SU)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: HIV Infections

Treatments: Biological: BCG delayed

Study type: Interventional

Funder types: Other

Identifiers

NCT00331474

N06/04/071

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Maternal HIV status verified
• Study consent
• Uncomplicated singleton pregnancy with delivery planned at local health facility
• Resident in study area

Exclusion criteria

• Active tuberculosis or tuberculosis contact in mother
• No consent
• Planning to move out of study area
• Not planning on delivering at local maternal obstetric unit
• Not planning on attending local baby clinic

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)