Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People

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. Identifier: NCT00052195
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 19, 2016
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center

Brief Summary:
A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Condition or disease Intervention/treatment Phase
Tuberculosis HIV Infections Biological: SRL-172 Phase 2 Phase 3

Detailed Description:

Disseminated infection with Mycobacterium tuberculosis (dMTB) has been documented in 10% to 25% of patients with HIV infection in Africa. Unlike pulmonary tuberculosis (pMTB), most cases of dMTB are not recognized and death ensues rapidly. Therefore, dMTB may be a more important cause of HIV-associated mortality than pMTB in developing countries. Mycobacterium vaccae (MV) is an investigational vaccine prepared by heat inactivation of a nontuberculous mycobacteria. MV immunization may reduce the risk of HIV-associated dMTB. The purpose of this study is to define risk factors for HIV-associated dMTB and to assess the safety and effectiveness of an MV vaccine for the prevention of HIV-associated pulmonary and disseminated tuberculosis.

HIV positive patients with prior BCG immunization and HIV negative controls will be entered in a 5-year study in Tanzania. Participants will be randomized to receive a 5-dose series of MV or placebo over 12 months, with a repeat skin test at Month 14. Baseline evaluation will include medical history, chest x-ray, skin tests with purified protein derivative (PPD), and blood tests to evaluate interferon-gamma production. Participants with PPD reactions greater than or equal to 5 mm will receive 6 months of prophylaxis with isoniazid. Participants will be followed every 3 months for 3 to 5 years to assess new pMTB (microbiologic or clinical diagnosis) or dMTB (microbiologic diagnosis). Potential risk factors for dMTB will also be assessed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1975 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)
Study Start Date : September 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: B Biological: SRL-172
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months

Experimental: A Biological: SRL-172
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months

Primary Outcome Measures :
  1. safety and efficacy of a prime-boost immunization strategy for the prevention of HIV-associated dTB and pTB [ Time Frame: every six months ]

Secondary Outcome Measures :
  1. Risk factors for HIV-associated dTB and relative contributions of primary infection, reinfection, and reactivation in its pathogenesis [ Time Frame: every six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • HIV infection
  • CD4 count more than 200 cells/mm3
  • BCG scar

Exclusion Criteria:

  • Active tuberculosis. Patients will be deferred from study enrollment until they show no signs of active disease.
  • Serious underlying disease (e.g., congestive heart failure, advanced cancer)
  • Life expectancy of less than 2 years
  • Pregnancy. Women who are pregnant may be eligible for the study after they give birth.

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 identifier (NCT number): NCT00052195

Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: C. Fordham F von Reyn, MD Dartmouth-Hitchcock Medical Center

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: C. Fordham von Reyn, Professor of Medicine, Dartmouth-Hitchcock Medical Center Identifier: NCT00052195     History of Changes
Other Study ID Numbers: 1R01AI045407-01A2 ( U.S. NIH Grant/Contract )
1R01AI045407-01A2 ( U.S. NIH Grant/Contract )
3R01AI045407-02S1 ( U.S. NIH Grant/Contract )
5R01AI045407-03 ( U.S. NIH Grant/Contract )
U01AI045407-06 ( U.S. NIH Grant/Contract )
U01AI045407-07 ( U.S. NIH Grant/Contract )
U01AI045407-08 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center:
Mycobacterium vaccae
Disseminated tuberculosis

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections