Case Western Reserve University Tuberculosis Research Unit
  Integrating research to combat the global TB epidemic

Immunity Induced by BCG Vaccination of HIV-infected Infants

Type of Study

Prospective observational study


Case control study

Project Site

Worcester region of the Western Cape, South Africa

Sample Size

total 81 subjects
Infants were assigned to 1 of 3 groups:

  • 31 HIV-infected infants cases
  • 25 non-HIV-exposed, non-infected infants controls
  • 25 HIV-exposed, non-infected infants controls


Infants born to HIV-infected and HIV-uninfected women were recruited at clinics or maternity wards

Study Period


Goal of Study:

To guide a more comprehensive assessment of the risks and benefits associated with BCG vaccination in HIV-infected infants, we assessed whether BCG induces the immune response thought to be required to protect infants against TB. The immune determinants of vaccination-induced protection against TB are not fully understood. However, the T helper type 1 (Th1) cytokine response, characterized by interferon (IFN)\x96γ, tumor necrosis factor (TNF)\x96α, and interleukin (IL)\x962 production, is widely thought to be essential. Recently, we have shown that, in HIV-uninfected infants, BCG induces CD4 and CD8 T cell populations that express combinations of IFN-γ, TNF-α, and IL-2.

Objectives of Study:
  1. To determine whether BCG vaccination is immunogenic in HIV-infected infants (immune response in HIV-infected infants are compared with those in infants not exposed or infected with HIV)
  2. To determine the effect of antiretroviral therapy on the BCG-induced immune response
  3. To compare BCG induced immunity between HIV-exposed, non-infected and non-HIV exposed infants
Research Activities: