Early Versus Delayed BCG Vaccination of HIV-exposed Infants

This study has been completed.
Seattle Biomedical Research Institute
University of Stellenbosch
Information provided by (Responsible Party):
Dr Heather Jaspan, University of Cape Town
ClinicalTrials.gov Identifier:
First received: February 12, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries. Bacille Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune system of neonates also responds differently to BCG that to other vaccines and infections. We hypothesize that the routine immunization of neonates with BCG contributes to generalized immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and infections and increased rates of disease progression in those infants that become HIV-infected. However, delaying BCG until HIV testing is completed would result in operational difficulties, and may not induce the appropriate immune response. Delayed BCG would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We plan to assess immune cells in infants to determine the impact of the timing of BCG vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare the immune activation and disease progression of those infants that become HIV-infected in the BCG or control arms. Our results will provide key insights into the effect of BCG vaccination on immune responses to HIV as well as inform the optimal timing of BCG vaccination for HIV-exposed infants.

Condition Intervention Phase
HIV Exposure
HIV Infection
Biological: BCG
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Influence of BCG Immunization on Immune Responses and Disease Progression in South African HIV Exposed and Infected Infants

Resource links provided by NLM:

Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • T cell activation [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine Immunogenicity [ Time Frame: 6, 8, and 14 weeks of age ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • HIV disease progression [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 151
Study Start Date: June 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed BCG
BCG delayed to 8 weeks of age
Biological: BCG
Early BCG
BCG at birth; standard of care
Biological: BCG


Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy neonate
  • Maternal HIV
  • > 36 weeks gestation
  • Birth weight > 2.4kg
  • Remaining in area 4 months

Exclusion Criteria:

  • Complications during pregnancy and delivery
  • Household TB contacts
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02062580

Sponsors and Collaborators
University of Cape Town
Seattle Biomedical Research Institute
University of Stellenbosch
Principal Investigator: Heather B Jaspan, MD, PHD University of Cape Town
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Heather Jaspan, Senior Lecturer, University of Cape Town
ClinicalTrials.gov Identifier: NCT02062580     History of Changes
Other Study ID Numbers: MV-00-9-900-01871 
Study First Received: February 12, 2014
Last Updated: February 12, 2014
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:
Vaccine immunogenicity
Immune activation

ClinicalTrials.gov processed this record on May 26, 2016