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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00052195
First received: January 24, 2003
Last updated: May 28, 2008
Last verified: July 2007
  Purpose

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 Intervention Phase
Tuberculosis
HIV Infections
Biological: Mycobacterium vaccae
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Secondary Outcome Measures:
  • Risk factors for HIV-associated dTB and relative contributions of primary infection, reinfection, and reactivation in its pathogenesis [ Time Frame: every six months ] [ Designated as safety issue: No ]

Enrollment: 1975
Study Start Date: September 2001
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B Biological: Mycobacterium vaccae
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months
Experimental: A Biological: Mycobacterium vaccae
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052195

Locations
Tanzania
Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Investigators
Principal Investigator: C. Fordham F von Reyn, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: C. Fordham von Reyn, Professor of Medicine, Dartmouth Medical School
ClinicalTrials.gov Identifier: NCT00052195     History of Changes
Other Study ID Numbers: 1R01AI45407-01A2, 3R01AI045407-02S1, 5R01AI045407-03, U01 AI045407-06, U01 AI045407-07, U01 AI045407-08
Study First Received: January 24, 2003
Last Updated: May 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Mycobacterium vaccae
BCG
Disseminated tuberculosis

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

ClinicalTrials.gov processed this record on November 25, 2014