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Am J Trop Med Hyg ; 110(5): 892-901, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38531102

RESUMEN

Malaria eradication efforts prioritize safe and efficient vaccination strategies, although none with high-level efficacy against malaria infection are yet available. Among several vaccine candidates, Sanaria® PfSPZ Vaccine and Sanaria PfSPZ-CVac are, respectively, live radiation- and chemo-attenuated sporozoite vaccines designed to prevent infection with Plasmodium falciparum, the leading cause of malaria-related morbidity and mortality. We are conducting a randomized normal saline placebo-controlled trial called IDSPZV1 that will analyze the safety, tolerability, immunogenicity, and efficacy of PfSPZ Vaccine and PfSPZ-CVac administered pre-deployment to malaria-naive Indonesian soldiers assigned to temporary duties in a high malaria transmission area. We describe the manifold challenges of enrolling and immunizing 345 soldier participants at their home base in western Indonesia before their nearly 6,000-km voyage to eastern Indonesia, where they are being monitored for incident P. falciparum and Plasmodium vivax malaria cases during 9 months of exposure. The unique regulatory, ethical, and operational complexities of this trial demonstrate the importance of thorough planning, frequent communication, and close follow-up with stakeholders. Effective engagement with the military community and the ability to adapt to unanticipated events have proven key to the success of this trial.


Asunto(s)
Vacunas contra la Malaria , Malaria Falciparum , Malaria Vivax , Personal Militar , Plasmodium falciparum , Esporozoítos , Vacunas Atenuadas , Humanos , Vacunas contra la Malaria/inmunología , Vacunas contra la Malaria/uso terapéutico , Vacunas contra la Malaria/administración & dosificación , Indonesia/epidemiología , Malaria Falciparum/prevención & control , Malaria Falciparum/epidemiología , Esporozoítos/inmunología , Vacunas Atenuadas/inmunología , Vacunas Atenuadas/uso terapéutico , Plasmodium falciparum/inmunología , Malaria Vivax/prevención & control , Malaria Vivax/epidemiología , Masculino , Adulto , Adulto Joven , Plasmodium vivax/inmunología , Femenino
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