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


Delrieu, I; Leboulleux, D; Ivinson, K; Gessner, BD; Malaria Transmission Blocking Vaccine Technical Consultation Gro, ; (2015) Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine. Vaccine, 33 (13). pp. 1518-1526. ISSN 0264-410X DOI: 10.1016/j.vaccine.2015.01.050

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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.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
Faculty of Infectious and Tropical Diseases > Dept of Immunology and Infection
Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
PubMed ID: 25681064
Web of Science ID: 352045300003
URI: http://researchonline.lshtm.ac.uk/id/eprint/2137771

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