Abstract
Preventive immunization with whole inactivated Mycobacterium vaccae (MV) confers protection against HIV-associated tuberculosis (TB) in BCG-immunized adults with CD4 counts ≥200 cells/μl. We evaluated the immunogenicity of MV in the 2013 subjects of the phase III DarDarTrial using an interferon gamma (IFN-γ) enzyme linked immunosorbent assay (ELISA), tritiated thymidine lymphocyte proliferation assay (LPA) and an ELISA for antibodies to the TB glycolipid lipoarabinomannan (LAM). MV immunization boosts IFN-γ and LPA responses to MV sonicate, and antibody responses to LAM. Post-immunization immune responses to MV correlated with baseline clinical factors, but the responses did not predict protection from HIV-associated TB.
Trial registration:
ClinicalTrials.gov NCT00052195.
Copyright © 2010 Elsevier Ltd. All rights reserved.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
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Research Support, N.I.H., Extramural
MeSH terms
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Adult
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Antibodies, Bacterial / blood
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Antibody Formation
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Antigens, Bacterial / immunology
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Antitubercular Agents / administration & dosage
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BCG Vaccine / immunology
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Double-Blind Method
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Enzyme-Linked Immunosorbent Assay
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Female
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HIV Infections / complications*
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HIV Infections / immunology
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HIV Infections / microbiology
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Humans
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Interferon-gamma / immunology
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Isoniazid / administration & dosage
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Lipopolysaccharides / immunology
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Male
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Tanzania
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Tuberculin Test
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Tuberculosis / complications
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Tuberculosis / immunology
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Tuberculosis / prevention & control*
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Tuberculosis Vaccines / immunology*
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Viral Load
Substances
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Antibodies, Bacterial
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Antigens, Bacterial
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Antitubercular Agents
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BCG Vaccine
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Lipopolysaccharides
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Tuberculosis Vaccines
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lipoarabinomannan
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Interferon-gamma
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Isoniazid
Associated data
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ClinicalTrials.gov/NCT00052195