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