Guidance on the evaluation of Plasmodium vivax vaccines in populations exposed to natural infection.

Details

Serval ID
serval:BIB_803D176A3F47
Type
Article: article from journal or magazin.
Collection
Publications
Title
Guidance on the evaluation of Plasmodium vivax vaccines in populations exposed to natural infection.
Journal
Vaccine
Author(s)
Mueller I., Moorthy V.S., Brown G.V., Smith P.G., Alonso P., Genton B.
Working group(s)
WHO Malaria Vaccine Advisory Committee (MALVAC)
ISSN
1873-2518[electronic], 0264-410X[linking]
Publication state
Published
Issued date
2009
Volume
27
Number
41
Pages
5633-5643
Language
english
Abstract
In this paper we give guidance for the design and conduct of vaccine trials against Plasmodium vivax malaria. The paper supplements earlier guidelines on the planning of vaccine trials against Plasmodium falciparum malaria [WHO. Guidelines for the evaluation of Plasmodium falciparum vaccines in populations exposed to natural infections. Geneva: World Health Organization; 1997, http://www.who.int/vaccine_research/feuill_1_4-2.pdf], with further considerations in two later documents [Moorthy VS, Reed Z, Smith PG. Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. Vaccine 2007 July 9;25(28):5115-23; Moorthy V, Reed Z, Smith P. MALVAC 2008: measures of efficacy of malaria vaccines in phase 2b and phase 3 trials - scientific, regulatory and public health perspectives. Vaccine 2009 January 29;27(5):624-8]. We deal specifically with study design and methodological issues for the assessment of pre-erythrocytic and blood-stage vaccines against P. vivax. The role of vaccines in blocking transmission of P. vivax is not considered as the methodological issues are similar to those for P. falciparum, though longer follow-up would be required because of the potential for relapse discussed below. In this paper we discuss the rationale and background to trials of P. vivax vaccines, requirements for Phase IIb and Phase III field trials, implementation of clinical trials, methods of measurement and analysis, and ethical aspects.
Keywords
Animals, Clinical Trials as Topic, Humans, Malaria Vaccines/immunology, Malaria, Vivax/prevention & control, Plasmodium falciparum, Plasmodium vivax/immunology, Research Design
Pubmed
Create date
02/07/2010 19:47
Last modification date
20/08/2019 15:40
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