Showing 1–7 of 7 documents
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Dick Menzies, MD
… will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adult…
Dick Menzies, MD
The study is a pragmatic cluster randomized trial that is being conducted in 5 countries, with sites in 4 cities in Canada, Benin, Ghana, Indonesia and Vietnam. The unit of randomization is the health facility (24 health facilities randomized). The trial tests a complex intervent…
Gavin Churchyard, MD, PhD, Bernard Landry, MPH
…as a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10\^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to a second g…
Vanya Dhagat, MD
… tuberculosis infection. The study will be conducted at one clinical research site in India. The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "boost…
Souleymane Mboup, Robert Wilkinson, Bernard Landry
…(immunogenicity analysis set). This Phase II multi-country trial was conducted as a randomized, double-blind, placebo-controlled trial in 650 HIV-positive adults with no evidence of active TB disease. Subjects were stratified at the time of randomization by whether or not they w…
Amadou T LY
…mple size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children. MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M. tuberculosis. The clinical development consortium of this EDCTP program is preparin…
Angelique Luabeya, MD
…3 will enroll 9 subjects. This study is planned at a single clinical site in South Africa. The sizes specified for each study group were selected because they are judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I study rather than for stati…