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
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
University of Stellenbosch
ClinicalTrials.gov Identifier:
NCT00331474
First received: May 30, 2006
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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:

  • 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 Intervention Phase
HIV Infections
Biological: BCG delayed
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

Resource links provided by NLM:


Further study details as provided by University of Stellenbosch:

Primary Outcome Measures:
  • BCG-induced cellular immune responses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: May 2006
Estimated Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: BCG delayed
    early (birth) and delayed (14 weeks) intradermal BCG vaccination
    Other Name: early vs. delayed BCG
  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331474

Locations
South Africa
Desmond Tutu TB Centre
Cape Town, Western Cape Province, South Africa, 7505
Sponsors and Collaborators
University of Stellenbosch
Thrasher Research Fund
Investigators
Principal Investigator: Anneke C Hesseling, MD Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
  More Information

No publications provided

Responsible Party: Esther Steyn or Liesel Strauss, Stellenbosch University
ClinicalTrials.gov Identifier: NCT00331474     History of Changes
Other Study ID Numbers: N06/04/071
Study First Received: May 30, 2006
Last Updated: February 13, 2009
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Stellenbosch:
BCG
HIV
Immune responses
Delayed vaccination
Infant morbidity
Nutritional status
Morbidity
Mortality

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014