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Abstract. Successful establishment of a Plasmodium vivax sporozoite challenge model in humans is described. Eighteen healthy adult, malaria-naïve volunteers were randomly allocated to Groups A-C and exposed to 3 ± 1, 6 ± 1, and 9 ± 1 bites of Anopheles albimanus mosquitoes infected with P. vivax , respectively. Seventeen volunteers developed signs and symptoms consistent with malaria, and geometric mean prepatent periods of 11.1 days (9.3-11) for Group A; 10.8 days (9.8-11.9) for Group B; and 10.6 days (8.7-12.4) for Group C, with no statistically significant difference among groups (Kruskal-Wallis, P = 0.70). One volunteer exposed to eight mosquito bites did not develop a parasitemia. No differences in parasite density were observed and all individuals successfully recovered after anti-malarial treatment. None of the volunteers developed parasite relapses within an 18-month follow-up. In conclusion, malaria-naive volunteers can be safely and reproducibly infected with bites of 2-10 An. albimanus mosquitoes carrying P. vivax sporozoites. This challenge method is suitable for vaccine and anti-malarial drug testing.

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Considerable efforts and funding are available to shift from laboratory experiments to field trials. Field trials remain the definitive method to assess the real impact of different vaccines in the target populations. More rigorous side-by-side comparisons are needed between the different vaccines using standardized in-vitro and in-vivo testing, so that the most promising candidates will be selected for further development.