Clinical trial NCT00331474: The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Official title: The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: BCG
HIV
Immune responses
Delayed vaccination
Infant morbidity
Nutritional status
Morbidity
Mortality
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2006-05-31
Enrollment: 180
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: BCG-induced cellular immune responses
timeFrame: 1 year
Secondary outcomes:
measure: BCG scarring
timeFrame: 18 months
measure: Serum antibody responses
timeFrame: 52 weeks
measure: Tuberculosis incidence
timeFrame: 1 year
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu TB Centre
state: Western Cape Province
Study officials:
affiliation: Desmond Tutu TB Centre, Dept. Pediatrics and Child Health, Stellenbosch University
name: Anneke C Hesseling, MD
role: PRINCIPAL_INVESTIGATOR
References: