title: Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania.
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.
authors.affiliation: Dartmouth Medical School, Lebanon, NH 03756,USA. Timothy.Lahey@Dartmouth.edu
authors.forename: Timothy
authors.initials: T
authors.lastname: Lahey
authors.forename: Robert D
authors.initials: RD
authors.lastname: Arbeit
authors.forename: Muhammad
authors.initials: M
authors.lastname: Bakari
authors.forename: C Robert
authors.initials: CR
authors.lastname: Horsburgh
authors.forename: Mecky
authors.initials: M
authors.lastname: Matee
authors.forename: Richard
authors.initials: R
authors.lastname: Waddell
authors.forename: Lillian
authors.initials: L
authors.lastname: Mtei
authors.forename: Jenni M
authors.initials: JM
authors.lastname: Vuola
authors.forename: Kisali
authors.initials: K
authors.lastname: Pallangyo
authors.forename: C Fordham
authors.initials: CF
authors.lastname: von Reyn
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D000942:Antigens, Bacterial / Q000276:immunology; D000995:Antitubercular Agents / Q000008:administration & dosage; D001500:BCG Vaccine / Q000276:immunology; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000276:immunology / Q000382:microbiology; D006801:Humans; D007371:Interferon-gamma / Q000276:immunology; D007538:Isoniazid / Q000008:administration & dosage; D008070:Lipopolysaccharides / Q000276:immunology; D008297:Male; D013636:Tanzania; D014374:Tuberculin Test; D014376:Tuberculosis / Q000150:complications / Q000276:immunology / Q000517:prevention & control*; D032581:Tuberculosis Vaccines / Q000276:immunology*; D019562:Viral Load
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D000995:Antitubercular Agents; D001500:BCG Vaccine; D008070:Lipopolysaccharides; D032581:Tuberculosis Vaccines; C050016:lipoarabinomannan; D007371:Interferon-gamma; D007538:Isoniazid