This trial is active, not recruiting.

Condition hiv infections
Treatment bcg delayed
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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

BCG-induced cellular immune responses
time frame: 1 year

Secondary Outcomes

BCG scarring
time frame: 18 months
Serum antibody responses
time frame: 52 weeks
Tuberculosis incidence
time frame: 1 year

Eligibility Criteria

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

Additional Information

Official title The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Principal investigator Anneke C Hesseling, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Stellenbosch.