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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. 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
Thrasher Research Fund
Information provided by:
University of Stellenbosch

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: BCG delayed Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Biological: BCG delayed
    early (birth) and delayed (14 weeks) intradermal BCG vaccination
    Other Name: early vs. delayed BCG

Primary Outcome Measures :
  1. BCG-induced cellular immune responses [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. BCG scarring [ Time Frame: 18 months ]
  2. Serum antibody responses [ Time Frame: 52 weeks ]
  3. Tuberculosis incidence [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00331474

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South Africa
Desmond Tutu TB Centre
Cape Town, Western Cape Province, South Africa, 7505
Sponsors and Collaborators
University of Stellenbosch
Thrasher Research Fund
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Principal Investigator: Anneke C Hesseling, MD Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
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Responsible Party: Esther Steyn or Liesel Strauss, Stellenbosch University Identifier: NCT00331474    
Other Study ID Numbers: N06/04/071
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009
Keywords provided by University of Stellenbosch:
Immune responses
Delayed vaccination
Infant morbidity
Nutritional status
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases