Abstract
Development and Phase 3 testing of the most advanced malaria vaccine, RTS,S/AS01, indicates that malaria vaccine R&D is moving into a new phase. Field trials of several research malaria vaccines have also confirmed that it is possible to impact the host-parasite relationship through vaccine-induced immune responses to multiple antigenic targets using different platforms. Other approaches have been appropriately tested but turned out to be disappointing after clinical evaluation.As the malaria community considers the potential role of a first-generation malaria vaccine in malaria control efforts, it is an apposite time to carefully document terminated and ongoing malaria vaccine research projects so that lessons learned can be applied to increase the chances of success for second-generation malaria vaccines over the next 10 years.The most comprehensive resource of malaria vaccine projects is a spreadsheet compiled by WHO thanks to the input from funding agencies, sponsors and investigators worldwide. This spreadsheet, available from WHO's website, is known as "the rainbow table". By summarizing the published and some unpublished information available for each project on the rainbow table, the most comprehensive review of malaria vaccine projects to be published in the last several years is provided below.
Highlights
Few recent malaria vaccine review articles have attempted a comprehensive outline of all clinical trials that have occurred globally
Over two decades on from the first clinical trials of vaccines for malaria, much has been learned about the pipeline from discovery research in the laboratory to successful conduct and analysis of large-scale field studies, and one product is undergoing Phase 3 studies with a view to licensure
Substantial progress has been made in evaluating many antigens and scientists have learned much about the need to meet requirements of developers in establishing clear product profiles
Summary
Few recent malaria vaccine review articles have attempted a comprehensive outline of all clinical trials that have occurred globally. Phase 1b studies were underway in semiimmune populations in Kenya in 2010 [1] This project follows the previous studies of FMP001/AS02A, a vaccine based on the 3D7 allele of MSP1, and showing good immunogenicity but inadequate clinical efficacy in a Phase 2b trial [97], possibly because multiple vaccine alleles would be necessary to generate a sufficiently broad strain-transcending immune response. FMP2.1/AS02A A Phase 1a study with malaria naïve volunteers examining the effect of vaccination with FMP2.1, in which E. coli expressed AMA1 (3D7 strain) is adjuvanted with the GSK product AS02A, showed acceptable safety and induction of strong humoral and cell-mediated responses [109]. A Phase 1/2a challenge trial occurred in US volunteers at the end of 2010 [14]
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