The PATH Malaria Vaccine Initiative (MVI) presented a draft TPP f

The PATH Malaria Vaccine Initiative (MVI) presented a draft TPP for a stand-alone SSM-TBV against both P. falciparum and P. vivax that was used as the basis for discussion at the MVI-sponsored TBV workshop in 2010 and the malaria vaccine advisory committee (MALVAC) meeting the same year [15]. There was consensus among participants on a number of key elements, including that the vaccine would need to be amenable to campaign administration, and therefore safe for administration

to all who may transmit malaria parasites, effective in as few doses as possible for as long as possible, and low cost [16]. Temozolomide mw The WHO is currently leading an effort to develop consensus preferred product characteristics to guide the community’s progress toward developing a VIMT that meets the updated Roadmap goals; the characteristics Selleck Ruxolitinib with outstanding questions are described below. A critical gap in the TPP is the required vaccine effect (a combination of factors including efficacy and coverage) [20]

needed to support elimination efforts. Preliminary modeling data indicate that efficacy and coverage are equally important in the impact of a TBV [21]. Although the implications of this relationship on the required level of vaccine efficacy are not yet known, it is of critical importance to identify the minimally required efficacy (and coverage) to support defining stage-gate criteria that will inform early clinical decision-making.

In addition to mathematical models (reviewed in the Malaria Eradication Research Agenda [malERA] Consultative Group on Modeling, 2011 [8]), biological and population models may also help to inform these criteria [20]. There is general agreement that a vaccine designed to contribute to elimination would need to be suitable for for use in campaigns; however, it is still too early to have consensus on its exact formulation. In addition to the development of a stand-alone SSM-VIMT, which would not confer an immediate, direct benefit to the vaccine recipient, a vaccine targeting both SSM and other stage malaria antigens, a vaccine co-formulated with one targeting a different disease, and/or co-administration with another health intervention that targets the same population have been proposed. Strategies of combining antigens from different stages of the parasite lifecycle (such as RTS,S [22]) or of co-administering the vaccine with a transmission-blocking drug are some of those currently being explored and could prove to be synergistic, while leveraging the successes in product development to date.

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