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

HIV Infections Clinical Trial

Official title:

The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00331474
• Other study ID #: N06/04/071
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: May 30, 2006
• Last updated: February 13, 2009
• Start date: May 2006
• Est. completion date: August 2009

Study information

• Verified date: February 2009
• Source: University of Stellenbosch
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• BCG delayed
early (birth) and delayed (14 weeks) intradermal BCG vaccination

Locations

Country	Name	City	State
South Africa	Desmond Tutu TB Centre	Cape Town	Western Cape Province

Sponsors (2)

Lead Sponsor	Collaborator
University of Stellenbosch	Thrasher Research Fund

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCG-induced cellular immune responses		1 year	No
Secondary	BCG scarring		18 months	No
Secondary	Serum antibody responses		52 weeks	No
Secondary	Tuberculosis incidence		1 year	No