Report of a Consultation on the Optimization of Clinical Challenge Trials for Evaluation of Candidate Blood Stage Malaria Vaccines, 18–19 March 2009, Bethesda, MD, USA

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Title Report of a Consultation on the Optimization of Clinical Challenge Trials for Evaluation of Candidate Blood Stage Malaria Vaccines, 18–19 March 2009, Bethesda, MD, USA
Author Moorthy, V.S.; Diggs, C.; Ferro, S.; Good, Michael Francis; Herrera, S.; Hill, A.V.; Imoukhuede, E.B.; Kumar, S.; Loucq, C.; Marsh, K.; Ockenhouse, C.F.; Richie, T.L.; Sauerwein, R.W.
Journal Name Vaccine
Year Published 2009
Place of publication United Kingdom
Publisher Elsevier Ltd
Abstract Development and optimization of first generation malaria vaccine candidates has been facilitated by the existence of a well-established Plasmodium falciparum clinical challenge model in which infectious sporozoites are administered to human subjects via mosquito bite. While ideal for testing pre-erythrocytic stage vaccines, some researchers believe that the sporozoite challenge model is less appropriate for testing blood stage vaccines. Here we report a consultation, co-sponsored by PATH MVI, USAID, EMVI and WHO, where scientists from all institutions globally that have conducted such clinical challenges in recent years and representatives from regulatory agencies and funding agencies met to discuss clinical malaria challenge models. Participants discussed strengthening and harmonizing the sporozoite challenge model and considered the pros and cons of further developing a blood stage challenge possibly better suited for evaluating the efficacy of blood stage vaccines. This report summarizes major findings and recommendations, including an update on the Plasmodium vivax clinical challenge model, the prospects for performing experimental challenge trials in malaria endemic countries and an update on clinical safety data. While the focus of the meeting was on the optimization of clinical challenge models for evaluation of blood stage candidate malaria vaccines, many of the considerations are relevant for the application of challenge trials to other purposes.
Peer Reviewed Yes
Published Yes
Alternative URI http://dx.doi.org/10.1016/j.vaccine.2009.07.049
Volume 27
Issue Number 42
Page from 5719
Page to 5725
ISSN 0264-410X
Date Accessioned 2011-07-14
Date Available 2011-09-22T06:52:30Z
Language en_AU
Research Centre Institute for Glycomics
Faculty Faculty of Science, Environment, Engineering and Technology
Subject Biological Sciences
URI http://hdl.handle.net/10072/40964
Publication Type Journal Articles (Refereed Article)
Publication Type Code c1x

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