title: Safety and immunogenicity of a five-dose series of inactivated Mycobacterium vaccae vaccination for the prevention of HIV-associated tuberculosis.
abstract: Five doses of inactivated Mycobacterium vaccae vaccine were administered intradermally to 22 human immunodeficiency virus (HIV)-infected patients (11 bacille Calmette-Guérin [BCG]-positive and 11 BCG-negative) in Zambia whose CD4 lymphocyte counts were >/=200 cells/mm(3). HIV viral load and lymphocyte proliferation responses were compared for vaccine recipients and 22 HIV-infected control patients (11 BCG-positive and 11 BCG-negative). Immunization was safe and well tolerated in all patients, and induration at the vaccine site decreased from dose 1 to dose 5. A transient decrease in HIV viral load was observed in BCG-positive vaccine recipients after dose 3 but not after subsequent doses. Median lymphocyte stimulation indices to M. vaccae were 6.0 in vaccine recipients and 2.3 in control patients (P<.001). Stimulation indices were >/=3.0 in 19 vaccine recipients (86%) and 7 control patients (32%; P=.001). A 5-dose series of vaccination with inactivated M. vaccae is safe in HIV-infected patients and induces lymphocyte proliferation responses to the vaccine antigen. M. vaccae vaccine is a candidate for the prevention of tuberculosis in HIV infection.
authors.affiliation: Infectious Disease Section, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Waddell
authors.forename: C
authors.initials: C
authors.lastname: Chintu
authors.forename: A D
authors.initials: AD
authors.lastname: Lein
authors.forename: A
authors.initials: A
authors.lastname: Zumla
authors.forename: M R
authors.initials: MR
authors.lastname: Karagas
authors.forename: K S
authors.initials: KS
authors.lastname: Baboo
authors.forename: J D
authors.initials: JD
authors.lastname: Habbema
authors.forename: A N
authors.initials: AN
authors.lastname: Tosteson
authors.forename: P
authors.initials: P
authors.lastname: Morin
authors.forename: S
authors.initials: S
authors.lastname: Tvaroha
authors.forename: R D
authors.initials: RD
authors.lastname: Arbeit
authors.forename: A
authors.initials: A
authors.lastname: Mwinga
authors.forename: C F
authors.initials: CF
authors.lastname: von Reyn
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D000328:Adult; D001500:BCG Vaccine / Q000008:administration & dosage; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007371:Interferon-gamma / Q000097:blood; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology*; D013183:Sputum / Q000382:microbiology; D014374:Tuberculin Test; D014397:Tuberculosis, Pulmonary / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology
chemical_list: D001500:BCG Vaccine; D001428:Bacterial Vaccines; D015164:Vaccines, Inactivated; D007371:Interferon-gamma