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

NCT00331474 | Unknown Phase 1

• 1 other identifier: N06/04/071
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

BCG; HIV; Immune responses; Delayed vaccination; Infant morbidity; Nutritional status; Morbidity; Mortality

Outcome Measures

Primary Outcomes (1)

• BCG-induced cellular immune responses

  1 year

Secondary Outcomes (3)

• BCG scarring

  18 months

• Serum antibody responses

  52 weeks

• Tuberculosis incidence

  1 year

Interventions

BCG delayed BIOLOGICAL

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

Also known as: early vs. delayed BCG

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Maternal HIV status verified
• Study consent
• Uncomplicated singleton pregnancy with delivery planned at local health facility
• Resident in study area

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Stellenbosch: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Desmond Tutu TB Centre

Cape Town, Western Cape, 7505, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Anneke C Hesseling, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

ZA (1)