The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Sponsor||University of Stellenbosch|
|Collaborator||Thrasher Research Fund|
|Start date||May 2006|
|End date||December 2008|
|Trial size||180 participants|
|Trial identifier||NCT00331474, N06/04/071|
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.
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
BCG-induced cellular immune responses
time frame: 1 year
time frame: 18 months
Serum antibody responses
time frame: 52 weeks
time frame: 1 year
Male or female participants up to 48 hours old.
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
|Official title||The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants|
|Principal investigator||Anneke C Hesseling, MD|
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