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Mycobacterium vaccae - DMID 94-120

Safety and Preliminary Evidence for Microbiologic and Immunologic Activity of Heat-Killed Mycobacterium vaccae Immunotherapeutic Agent as an Adjunct to Combination Chemotherapy for the Initial Treatment of Pulmonary Tuberculosis in HIV-non-infected Adults in Uganda

Information:

DMID Protocol Number: 94-120

Type of Study

Phase I/II Clinical Trial

Design

Randomized, placebo-control trial
Phase I is 8 week safety data, if NIH and FDA approved, subject will be rolled over into Phase II

Project Site

Kampala, Uganda

Sample Size

104 subjects

Population

HIV-non-infected, male or female, adults 18-60 years old, with newly diagnosed initial episodes of smear positive/culture confirmed pulmonary tuberculosis

  • 20 adults in phase I
  • 84 adults in phase II

Study Period

1994-2001

Goal of Study:

The study will assist with the identification of immunologic correlates of protective immunity in humans, and evaluate related microbiologic effects of heat-killed M. vaccae immunotherapy. The study will evaluate the short term and long term safety and activity of the heat-killed M. vaccae immunotherapeutic agent for the initial treatment of pulmonary tuberculosis in HIV-non-infected patients in Ugandan adults.

Objectives of Study:

  1. To determine rate of local and systemic adverse events
  2. To determine rate of sputum culture conversion during treatment with combination anti-TB chemotherapy
  3. To determine rate of increase of stimulated IFN-γ production by peripheral mononuclear cells
  4. To determine rate of decrease in serum IgG and IgM antibodies to M. tuberculosis culture filtrate

The results of this study can be found in:

Johnson JL, Kamya RM, Okwera A, Loughlin AM, Nyole S, Hom D, Wallis RS, Hirsch CM, Wolski KW, Foulds J, Mugerwa RD, Ellner JJ for the Uganda-Case Western Reserve Research Collaboration. Randomized controlled trial of Mycobacterimvaccae immunotherapy in non-Human Immunodeficiency Virus-infected Ugandan adults with newly diagnosed pulmonary tuberculosis. J Infect Dis 2000; 181:1304-1312.