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

NCT ID: NCT00331474

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

BCG delayed

early (birth) and delayed (14 weeks) intradermal BCG vaccination

Intervention Type: BIOLOGICAL

Other Intervention Names

early vs. delayed BCG

Eligibility 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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

University of Stellenbosch

OTHER

Sponsor Role: lead

Responsible Party

Stellenbosch University

Principal Investigators

Anneke C Hesseling, MD

Role: PRINCIPAL_INVESTIGATOR

Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University

Locations

Desmond Tutu TB Centre

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

N06/04/071

Identifier Type: -

Identifier Source: org_study_id