The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
- Conditions
- HIV Infections
- Registration Number
- NCT00331474
- Lead Sponsor
- University of Stellenbosch
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Maternal HIV status verified
- Study consent
- Uncomplicated singleton pregnancy with delivery planned at local health facility
- Resident in study area
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method BCG-induced cellular immune responses 1 year
- Secondary Outcome Measures
Name Time Method Serum antibody responses 52 weeks Tuberculosis incidence 1 year BCG scarring 18 months
Trial Locations
- Locations (1)
Desmond Tutu TB Centre
🇿🇦Cape Town, Western Cape Province, South Africa