Early Versus Delayed BCG Vaccination of HIV-exposed Infants

This study has been completed.
Sponsor:
Collaborators:
Seattle Biomedical Research Institute
University of Stellenbosch
Information provided by (Responsible Party):
​Dr Heather Jaspan, University of Cape Town
ClinicalTrials.gov Identifier:
NCT02062580
First received: February 12, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

February 12, 2014
February 12, 2014
June 2010
April 2012   (final data collection date for primary outcome measure)
T cell activation [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Vaccine Immunogenicity [ Time Frame: 6, 8, and 14 weeks of age ] [ Designated as safety issue: No ]
Same as current
HIV disease progression [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
Influence of BCG Immunization on Immune Responses and Disease Progression in South African HIV Exposed and Infected Infants

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • HIV Exposure
  • HIV Infection
Biological: BCG
  • Active Comparator: Delayed BCG
    BCG delayed to 8 weeks of age
    Intervention: Biological: BCG
  • Early BCG
    BCG at birth; standard of care
    Intervention: Biological: BCG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
up to 24 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT02062580
MV-00-9-900-01871
No
​Dr Heather Jaspan, University of Cape Town
University of Cape Town
  • Seattle Biomedical Research Institute
  • University of Stellenbosch
Principal Investigator: Heather B Jaspan, MD, PHD University of Cape Town
University of Cape Town
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP