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Reference: Roestenberg, M, O'Hara, GA, Duncan, CJA et al., (2012). Comparison of clinical and parasitological data from controlled human malaria infection trials. PloS one, 7 (6), Article: e38434.Citable link to this page:

 

Comparison of clinical and parasitological data from controlled human malaria infection trials.

Abstract: BACKGROUND: Exposing healthy human volunteers to Plasmodium falciparum-infected mosquitoes is an accepted tool to evaluate preliminary efficacy of malaria vaccines. To accommodate the demand of the malaria vaccine pipeline, controlled infections are carried out in an increasing number of centers worldwide. We assessed their safety and reproducibility. METHODS: We reviewed safety and parasitological data from 128 malaria-naïve subjects participating in controlled malaria infection trials conducted at the University of Oxford, UK, and the Radboud University Nijmegen Medical Center, The Netherlands. Results were compared to a report from the US Military Malaria Vaccine Program. RESULTS: We show that controlled human malaria infection trials are safe and demonstrate a consistent safety profile with minor differences in the frequencies of arthralgia, fatigue, chills and fever between institutions. But prepatent periods show significant variation. Detailed analysis of Q-PCR data reveals highly synchronous blood stage parasite growth and multiplication rates. CONCLUSIONS: Procedural differences can lead to some variation in safety profile and parasite kinetics between institutions. Further harmonization and standardization of protocols will be useful for wider adoption of these cost-effective small-scale efficacy trials. Nevertheless, parasite growth rates are highly reproducible, illustrating the robustness of controlled infections as a valid tool for malaria vaccine development.

Publication status:Published Funder: Top Institute Pharma   Funder: Dioraphte Foundation   Funder: Medical Research Council   Funder: Wellcome Trust   Funder: European Commission   Funder: European Vaccine Initiative   Funder: PATH Malaria Vaccine Initiative   Funder: National Institute for Health Research   Notes:This is an open-access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

Bibliographic Details

Publisher: Public Library of Science

Publisher Website: http://www.plos.org

Journal: PloS onesee more from them

Publication Website: http://www.plosone.org

Issue Date: 2012

pages:Article: e38434Identifiers

Urn: uuid:36bc8c57-8683-4fe8-83dc-deb1c2e8f0ef

Source identifier: 340152

Eissn: 1932-6203

Doi: https://doi.org/10.1371/journal.pone.0038434

Issn: 1932-6203 Item Description

Type: Journal article;

Language: eng Keywords: Humans Plasmodium falciparum Parasitemia Malaria, Falciparum Analysis of Variance Malaria Vaccines Statistics, Nonparametric Polymerase Chain Reaction Human Experimentation Adult Clinical Trials as Topic Middle Aged Female Male Tiny URL: pubs:340152

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Autor: Roestenberg, M - - - O'Hara, GA - institutionUniversity of Oxford - - - Duncan, CJA - institutionUniversity of Oxford - - - E

Fuente: https://ora.ox.ac.uk/objects/uuid:36bc8c57-8683-4fe8-83dc-deb1c2e8f0ef



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