European Vaccine Initiative: lessons from developing malaria vaccines

Figures & data

Figure 1. European Vaccine Initiative-funded projects and status at the end of 2010.

EDCTP: European and Developing Countries Clinical Trials Partnership; EMVDA: European Malaria Vaccine Development Association; EVI: European Vaccine Initiative; GMP: Good manufacturing practice.

Reproduced with permission from [112].

Figure 2. Growth inhibition assay titers in PfAMA1 vaccinated and control subjects (intention to treat) at 10 mg/ml total IgG.

Individual data points are plotted as well as a box indicating median and 25 and 75% quintiles.

Data taken from [Thera M, Unpublished Data].

Table 1. Assessment criteria for development of malaria vaccines: rationale for choice of antigen.

Attribute	Criteria	Comments
Stage of parasite	Must be defined
Accessibility	Specific antibodies must react with intact parasites by IFA
Functionality	Should have functional assay	Examples: erythrocyte binding, growth inhibition
In vivo protection after immunization with the vaccine antigen in an animal model	Demonstration is a strong justification for further development
In vitro inhibition	Demonstration bolsters rationale for further development
Sequence diversity	Must be characterized Rationale for development plan must be presented	Arguments can be mounted for promise of both high- and low-diversity antigens
Parasite dependence on antigen	Must be characterized Rationale for development plan must be presented	Parasite dependence on antigen best determined by ability (or inability) to knock out gene
Epidemiological association of antigen with protection	Available information must be present	Presence is encouraging, but subject to the fallacy of interpretation of association as causality Also consider vaccine potential that does not mimic nature
Antigenicity	Must react with antibodies or cells of infected and/or immunized individuals
Pre-existing clinical data	Must be considered in development plan	Data from any prior trials must be provided, if possible

IFA: Immunofluorescence assay.

Reproduced with permission from [104].

European Vaccine Initiative: vaccine Development. www.euvaccine.eu/portfolio/vaccine-development

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Assessment criteria for evaluation of malaria vaccine concepts prior to clinical lot production: rationale for choice of antigen. 2008. www.euvaccine.eu/sites/default/files/uploads/docs/Projects/2008_EURHAVAC_criteria.pdf

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