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Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine

Delrieu, I. and Leboulleux, D. and Ivinson, K. and Gessner, B. D. and Chandramohan, D. and Churcher, T. and Drakeley, C. and Halloran, E. and Killen, G. and Kleinschmidt, I. and Milligan, P. and Robert, V. and Rogier, C. and Saul, A. and Sinden, R. and Smith, T.. (2015) Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine. Vaccine, Vol. 33, H. 13. S. 1518-1526.

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Official URL: http://edoc.unibas.ch/dok/A6373512

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Abstract

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.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Epidemiology and Public Health (EPH) > Health Systems Research and Dynamic Modelling > Dynamical Modelling (Smith)
UniBasel Contributors:Smith, Thomas A.
Item Type:Article, refereed
Bibsysno:Link to catalogue
Publisher:Elsevier ; [Online:] Amsterdam
ISSN:0264-410X
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:03 Jul 2015 08:53
Deposited On:03 Jul 2015 08:53

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