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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine
AIDS, Volume 24, No. 5, Year 2010
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Description
Objective: To determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis. Design and Methods: The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/μl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints). Results: Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events. Conclusion: Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
von Reyn, Charles Fordham
United States, Lebanon
Dartmouth-hitchcock Medical Center
Mtei, Lillian N.
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Arbeit, Robert D.
United States, Boston
Tufts University School of Medicine
Waddell, R.
United States, Lebanon
Dartmouth-hitchcock Medical Center
Cole, Bernard F.
United States, Burlington
The University of Vermont
MacKenzie, Todd A.
United States, Hanover
Geisel School of Medicine at Dartmouth
Matee, Mecky Isaac N.
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Bakari, Muhammad
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Tvaroha, Susan
United States, Lebanon
Dartmouth-hitchcock Medical Center
Adams, Lisa V.
United States, Lebanon
Dartmouth-hitchcock Medical Center
Horsburgh, Charles Robert
United States, Boston
School of Public Health
Pallangyo, Kisali J.
Tanzania, Dar es Salaam
Muhimbili University of Health and Allied Sciences
Statistics
Citations: 209
Authors: 12
Affiliations: 6
Identifiers
Doi:
10.1097/QAD.0b013e3283350f1b
e-ISSN:
14735571
Research Areas
Disability
Environmental
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Tanzania