Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Stellenbosch.
Recruitment status was  Active, not recruiting
Thrasher Research Fund
Information provided by:
University of Stellenbosch Identifier:
First received: May 30, 2006
Last updated: February 13, 2009
Last verified: February 2009

May 30, 2006
February 13, 2009
May 2006
December 2008   (final data collection date for primary outcome measure)
BCG-induced cellular immune responses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00331474 on Archive Site
  • BCG scarring [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Serum antibody responses [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Tuberculosis incidence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants


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.

Not Provided
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Biological: BCG delayed
early (birth) and delayed (14 weeks) intradermal BCG vaccination
Other Name: early vs. delayed BCG
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
August 2009
December 2008   (final data collection date for primary outcome measure)

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
up to 48 Hours
Contact information is only displayed when the study is recruiting subjects
South Africa
Not Provided
Esther Steyn or Liesel Strauss, Stellenbosch University
University of Stellenbosch
Thrasher Research Fund
Principal Investigator: Anneke C Hesseling, MD Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
University of Stellenbosch
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP