کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10963148 1102673 2015 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine
چکیده انگلیسی
Vaccines interrupting Plasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens (SSM-VIMT) are currently under development to reduce malaria transmission. An international group of malaria experts was established to evaluate the feasibility and optimal design of a Phase III cluster randomized trial (CRT) that could support regulatory review and approval of an SSM-VIMT. The consensus design is a CRT with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. Trials should be conducted first in areas of moderate transmission, where SSM-VIMT impact should be greatest. Sample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 33, Issue 13, 24 March 2015, Pages 1518-1526
نویسندگان
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