%0 Journal Article
%T Implementation of a Randomized, Placebo-Controlled Trial of Live Attenuated Malaria Sporozoite Vaccines in an Indonesian Military Study Population.
%A Indrihutami K
%A Chand K
%A Fahmia R
%A Rachmat A
%A Rahardjani M
%A Wulandari F
%A Subekti D
%A Noviyanti R
%A Sutanto I
%A Soebandrio A
%A Mallisa NT
%A Mardika IM
%A Budiman W
%A Suriswan I
%A Ertanto Y
%A Chen MC
%A Murshedkar T
%A Abebe Y
%A James ER
%A Billingsley PF
%A Sim BKL
%A Hoffman SL
%A Richie TL
%A Chen S
%A Elyazar IRF
%A Ekawati LL
%A Baird JK
%A Nelwan EJ
%J Am J Trop Med Hyg
%V 110
%N 5
%D 2024 May 1
%M 38531102
%F 3.707
%R 10.4269/ajtmh.23-0597
%X 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.