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Sponsors and Collaborators: |
University of Stellenbosch Thrasher Research Fund |
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Information provided by: | University of Stellenbosch |
ClinicalTrials.gov Identifier: | NCT00331474 |
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:
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: BCG delayed |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1: The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants |
Estimated Enrollment: | 100 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | up to 48 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anneke C Hesseling, MD | 0027 21 938 ext 9177 | annekeh@sun.ac.za |
Contact: Nulda Beyers, PhD | 0027 21 938 ext 9062 | nb@sun.ac.za |
South Africa, Western Cape Province | |
Desmond Tutu TB Centre | Recruiting |
Cape Town, Western Cape Province, South Africa, 7505 | |
Contact: Nulda Beyers, PhD 0027 21 938 ext 9062 nb@sun.ac.za | |
Principal Investigator: Anneke C Hesseling, MD. MSc | |
Sub-Investigator: Nulda Beyers, MD PhD | |
Sub-Investigator: Gill Black, PhD | |
Sub-Investigator: Ben J Marais, MD, PhD | |
Sub-Investigator: Simon H Schaaf, MD, PhD | |
Sub-Investigator: Robert P Gie, MD | |
Sub-Investigator: Mark F Cotton, MD, PhD |
Principal Investigator: | Anneke C Hesseling, MD | Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University |
Study ID Numbers: | N06/04/071 |
Study First Received: | May 30, 2006 |
Last Updated: | January 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00331474 |
Health Authority: | South Africa: Medicines Control Council |
BCG HIV Immune responses Delayed vaccination |
Infant morbidity Nutritional status Morbidity Mortality |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |