Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People
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Study type
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,975 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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