| Title: |
Implementation of a randomized, placebo-controlled trial of live attenuated malaria sporozoite vaccines in an Indonesian military study population |
| Authors: |
Indrihutami, K; Chand, K; Fahmia, R; Rahardjani, M; Wulandari, F; Subekti, D; Noviyanti, R; Soebandrio, A; Mallisa, NT; Mardika, IM; Budiman, W; Suriswan, I; Ertanto, Y; Chen, M-C; Murshedkar, T; Abebe, Y; Sim, BKL; Hoffman, SL; Richie, TL; Chen, S; Elyazar, IRF; Ekawati, LL; Baird, JK; Nelwan, EJ |
| Publisher Information: |
American Society of Tropical Medicine and Hygiene |
| Publication Year: |
2025 |
| Collection: |
Oxford University Research Archive (ORA) |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.4269/ajtmh.23-0597 |
| Availability: |
https://doi.org/10.4269/ajtmh.23-0597; https://ora.ox.ac.uk/objects/uuid:a608138b-683f-4d92-a9af-3b920152f25e |
| Rights: |
info:eu-repo/semantics/openAccess ; CC Attribution (CC BY) |
| Accession Number: |
edsbas.397C006E |
| Database: |
BASE |