The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00331474|
Recruitment Status : Unknown
Verified February 2009 by University of Stellenbosch.
Recruitment status was: Active, not recruiting
First Posted : May 31, 2006
Last Update Posted : February 16, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: BCG delayed||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||August 2009|
- Biological: BCG delayed
early (birth) and delayed (14 weeks) intradermal BCG vaccinationOther Name: early vs. delayed BCG
- BCG-induced cellular immune responses [ Time Frame: 1 year ]
- BCG scarring [ Time Frame: 18 months ]
- Serum antibody responses [ Time Frame: 52 weeks ]
- Tuberculosis incidence [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331474
|Desmond Tutu TB Centre|
|Cape Town, Western Cape Province, South Africa, 7505|
|Principal Investigator:||Anneke C Hesseling, MD||Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University|