Journal article
Implementation of a randomized, placebo-controlled trial of live attenuated malaria sporozoite vaccines in an Indonesian military study population
- 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.3MB, Terms of use)
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- Publisher copy:
- 10.4269/ajtmh.23-0597
Authors
+ Congressionally Directed Medical Research Programs
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- Funder identifier:
- https://ror.org/03g2zjp07
- Publisher:
- American Society of Tropical Medicine and Hygiene
- Journal:
- American Journal of Tropical Medicine and Hygiene More from this journal
- Volume:
- 110
- Issue:
- 5
- Pages:
- 892-901
- Place of publication:
- United States
- Publication date:
- 2024-03-26
- Acceptance date:
- 2023-11-24
- DOI:
- EISSN:
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1476-1645
- ISSN:
-
0002-9637
- Pmid:
-
38531102
- Language:
-
English
- Pubs id:
-
1940989
- Local pid:
-
pubs:1940989
- Deposit date:
-
2025-01-14
- ARK identifier:
Terms of use
- Copyright holder:
- Indrihutami et al.
- Copyright date:
- 2024
- Rights statement:
- © 2024 The author(s). This is an open access article under a Creative Commons license.
- Licence:
- CC Attribution (CC BY)
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