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Early Versus Delayed BCG Vaccination of HIV-exposed Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02062580
First Posted: February 13, 2014
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Seattle Biomedical Research Institute
University of Stellenbosch
Information provided by (Responsible Party):
Dr Heather Jaspan, University of Cape Town
  Purpose
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: None (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 Dr Heather Jaspan, University of Cape Town:

Primary Outcome Measures:
  • T Cell Activation [ Time Frame: at 6 weeks ]
    Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.


Secondary Outcome Measures:
  • Vaccine Immunogenicity [ Time Frame: 6 weeks after BCG vaccination ]
    Percent of CD4+ T cells expressing Ki67 after stimulation in vitro with BCG.


Enrollment: 149
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062580


Sponsors and Collaborators
University of Cape Town
Seattle Biomedical Research Institute
University of Stellenbosch
Investigators
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
First Submitted: February 12, 2014
First Posted: February 13, 2014
Results First Submitted: October 25, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: January 2017

Keywords provided by Dr Heather Jaspan, University of Cape Town:
Vaccine immunogenicity
Immune activation

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases