title: Preparing for future efficacy trials of severe malaria vaccines.
abstract: Severe malaria is a major cause of mortality in children, but comprises only a small proportion of Plasmodium falciparum infections in naturally exposed populations. The evaluation of vaccines that prevent severe falciparum disease will require clinical trials whose primary efficacy endpoint will be severe malaria risk during follow-up. Here, we show that such trials are feasible with fewer than 1000 participants in areas with intense malaria transmission during the age interval when severe malaria incidence peaks.
authors.affiliation: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States; Laboratory of Clinical Infectious Diseases-Epidemiology Unit, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States.
authors.forename: Bronner P
authors.initials: BP
authors.lastname: Gonçalves
authors.affiliation: Laboratory of Clinical Infectious Diseases-Epidemiology Unit, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States.
authors.forename: D Rebecca
authors.initials: DR
authors.lastname: Prevots
authors.affiliation: MOMS Project, Seattle Biomedical Research Institute (currently Center for Infectious Disease Research), Seattle, WA, United States; Muheza Designated District Hospital, Muheza, Tanzania.
authors.forename: Edward
authors.initials: E
authors.lastname: Kabyemela
authors.affiliation: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States; MOMS Project, Seattle Biomedical Research Institute (currently Center for Infectious Disease Research), Seattle, WA, United States; Muheza Designated District Hospital, Muheza, Tanzania.
authors.forename: Michal
authors.initials: M
authors.lastname: Fried
authors.affiliation: Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, United States; MOMS Project, Seattle Biomedical Research Institute (currently Center for Infectious Disease Research), Seattle, WA, United States; Muheza Designated District Hospital, Muheza, Tanzania. Electronic address: Patrick.duffy@mail.nih.gov.
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Duffy
mesh_terms: D002986:Clinical Trials as Topic; D005240:Feasibility Studies; D006801:Humans; D007223:Infant; D008137:Longitudinal Studies; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D016778:Malaria, Falciparum / Q000517:prevention & control*; D010963:Plasmodium falciparum; D011159:Population Surveillance; D012307:Risk Factors; D013636:Tanzania
chemical_list: D017780:Malaria Vaccines
keywords: Clinical trial; Immunity; Sample size; Severe malaria; Vaccine