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