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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00052195
First received: January 24, 2003
Last updated: February 17, 2016
Last verified: February 2016

January 24, 2003
February 17, 2016
September 2001
December 2008   (final data collection date for primary outcome measure)
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 ]
  • Risk factors for HIV-associated dTB and relative contributions of primary infection, reinfection, and reactivation in its pathogenesis
  • safety and efficacy of a prime-boost immunization strategy for the prevention of HIV-associated dTB and pTB
Complete list of historical versions of study NCT00052195 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People
DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Tuberculosis
  • HIV Infections
Biological: SRL-172
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months
  • Placebo Comparator: B
    Intervention: Biological: SRL-172
  • Experimental: A
    Intervention: Biological: SRL-172

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1975
May 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00052195
1R01AI045407-01A2, 1R01AI045407-01A2, 3R01AI045407-02S1, 5R01AI045407-03, U01AI045407-06, U01AI045407-07, U01AI045407-08
Yes
Not Provided
Not Provided
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: C. Fordham F von Reyn, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP