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Experimental infection and protection against ... - TI Pharma

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52 Chapter 2<br />

Although this phase I trial is limited with respect to the size <strong>and</strong> generalizibility<br />

to the target population, it met its objectives to outline a generalizable safety<br />

profile. Specifically the direct comparison of the safety profile of different<br />

adjuvants is valuable for future development of AMA1 <strong>and</strong> other malaria<br />

vaccines. Furthermore, the malaria vaccine c<strong>and</strong>idate AMA1 provides the<br />

possibility of assessing functionality of the immune response by a parasite<br />

growth inhibition assay. However, it must be noted that the growth inhibition<br />

assay is not validated as a correlate of <strong>protection</strong>, <strong>and</strong> is as such a limited<br />

predictor for efficacy.<br />

With this study we have shown that the PfAMA1 vaccine combined with<br />

different adjuvants, Alhydrogel, Montanide <strong>and</strong> AS02 provided distinct<br />

reactogenicity profiles. All vaccine formulation were immunogenic at both<br />

dosages. Growth inhibition results indicate that induction of functional immune<br />

responses is probably dependent on adjuvant, underscoring the need for strong<br />

immunopotentiators for malaria vaccines. Altogether, these results are<br />

promising for a future development of a PfAMA1 malaria vaccine.<br />

Acknowledgements<br />

We thank Dominique Lemoine <strong>and</strong> Natalie Imbault for their comments <strong>and</strong><br />

contribution to the manuscript<br />

Funding<br />

This work was supported by a grant from the European Malaria Vaccine<br />

Initiative.

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