title: Malaria vaccine efficacy: the difficulty of detecting and diagnosing malaria.
abstract: New sources of funding have revitalized efforts to control malaria. An effective vaccine would be a tremendous asset in the fight against this devastating disease and increasing financial and scientific resources are being invested to develop one. A few candidates have been tested in Phase I and II clinical trials, and several others are poised to begin trials soon. Some studies have been promising, and others disappointing. It is difficult to compare the results of these clinical trials; even independent trials of the same vaccine give highly discrepant results. One major obstacle in evaluating malaria vaccines is the difficulty of diagnosing clinical malaria. This analysis evaluates the impact of diagnostic error, particularly that introduced by microscopy, on the outcome of efficacy trials of malaria vaccines and make recommendations for improving future trials.
authors: Fogarty International Center, NIH, Bethesda, Maryland, USA. prudhomw@mail.nih.gov
authors: Wendy Prudhomme
authors: WP
authors: O'Meara
authors: B Fenton
authors: BF
authors: Hall
authors: F Ellis
authors: FE
authors: McKenzie
mesh_terms: D000328:Adult; D000367:Age Factors; D000818:Animals; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000706:statistics & numerical data; D003951:Diagnostic Errors; D005188:False Negative Reactions; D005189:False Positive Reactions; D005334:Fever / Q000209:etiology; D006801:Humans; D008018:Life Cycle Stages; D016015:Logistic Models; D008288:Malaria / Q000175:diagnosis*; D017780:Malaria Vaccines; D018512:Parasitemia / Q000097:blood / Q000175:diagnosis*; D018579:Patient Selection; D010961:Plasmodium / Q000254:growth & development / Q000302:isolation & purification / Q000502:physiology; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D035501:Uncertainty; D014611:Vaccination
chemical_list: D017780:Malaria Vaccines