{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:37:29Z","timestamp":1787499449361,"version":"build-2736575974"},"reference-count":13,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"5","license":[{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,5,1]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>\n                    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\n                    <jats:sup>\u00ae<\/jats:sup>\n                    PfSPZ Vaccine and Sanaria PfSPZ-CVac are, respectively, live radiation- and chemo-attenuated sporozoite vaccines designed to prevent infection with\n                    <jats:italic>Plasmodium falciparum<\/jats:italic>\n                    , 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\n                    <jats:italic>P. falciparum<\/jats:italic>\n                    and\n                    <jats:italic>Plasmodium vivax<\/jats:italic>\n                    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.\n                  <\/jats:p>","DOI":"10.4269\/ajtmh.23-0597","type":"journal-article","created":{"date-parts":[[2024,3,26]],"date-time":"2024-03-26T15:25:11Z","timestamp":1711466711000},"page":"892-901","source":"Crossref","is-referenced-by-count":1,"title":["Implementation of a Randomized, Placebo-Controlled Trial of Live Attenuated Malaria Sporozoite Vaccines in an Indonesian Military Study Population"],"prefix":"10.4269","volume":"110","author":[{"given":"Khoriah","family":"Indrihutami","sequence":"first","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisin","family":"Chand","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rizka","family":"Fahmia","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mutia","family":"Rahardjani","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fitria","family":"Wulandari","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Decy","family":"Subekti","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rintis","family":"Noviyanti","sequence":"additional","affiliation":[{"name":"Eijkman Research Center for Molecular Biology, National Research & Innovation Agency, Cibinong, West Java, Indonesia;"},{"name":"EXEINS Health Initiative, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amin","family":"Soebandrio","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noch T.","family":"Mallisa","sequence":"additional","affiliation":[{"name":"Presidential Staff Office, Republic of Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I Made","family":"Mardika","sequence":"additional","affiliation":[{"name":"Gatot Soebroto Army Hospital, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waras","family":"Budiman","sequence":"additional","affiliation":[{"name":"Muhammadiyah University, Surabaya, East Java, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irwan","family":"Suriswan","sequence":"additional","affiliation":[{"name":"Gatot Soebroto Army Hospital, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yogi","family":"Ertanto","sequence":"additional","affiliation":[{"name":"Army Medical Center, Army of the Republic of Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mei-Chun","family":"Chen","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tooba","family":"Murshedkar","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yonas","family":"Abebe","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. Kim Lee","family":"Sim","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen L.","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas L.","family":"Richie","sequence":"additional","affiliation":[{"name":"Sanaria Inc., Rockville, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sky","family":"Chen","sequence":"additional","affiliation":[{"name":"StatPlus, Inc. Taipei, Taiwan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iqbal R. F.","family":"Elyazar","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lenny L.","family":"Ekawati","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"},{"name":"Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Kevin","family":"Baird","sequence":"additional","affiliation":[{"name":"Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia;"},{"name":"Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erni J.","family":"Nelwan","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia;"},{"name":"Division of Tropical Medicine and Infectious Disease, Department of Internal Medicine, Cipto Mangunkusumo Hospital, Jakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"b1"},{"key":"b2","series-title":"J Physiol Anthropol","first-page":"1","article-title":"Plasmodium \u2013 a brief introduction to the parasites causing human malaria and their basic biology","volume":"40","author":"Sato","year":"2021"},{"key":"b3","series-title":"One Health","first-page":"100389","article-title":"Primate malaria: an emerging challenge of zoonotic malaria in Indonesia","volume":"14","author":"Lempang","year":"2022"},{"key":"b4","series-title":"Global Technical Strategy for Malaria, 2016\u20132030","year":"2021"},{"key":"b5","series-title":"WHO Review of Malaria Vaccine Clinical Development","year":"2022"},{"key":"b6","series-title":"Nature","first-page":"445","article-title":"Sterile protection against human malaria by chemoattenuated PfSPZ vaccine","volume":"542","author":"Mordm\u00fcller","year":"2017"},{"key":"b7","series-title":"Hum Vaccin","first-page":"97","article-title":"Development of a metabolically active, non-replicating sporozoite vaccine to prevent Plasmodium falciparum malaria","volume":"6","author":"Hoffman","year":"2010"},{"key":"b8","series-title":"Expert Rev Vaccines","first-page":"967","article-title":"Sporozoite immunization: innovative translational science to support the fight against malaria","volume":"22","author":"Richie","year":"2023"},{"key":"b9","series-title":"Sci Transl Med","first-page":"eabj3776","article-title":"A randomized controlled trial showing safety and efficacy of a whole sporozoite vaccine against endemic malaria","volume":"14","author":"Sirima","year":"2022"},{"key":"b10","series-title":"Nature","first-page":"289","article-title":"Two chemoattenuated PfSPZ malaria vaccines induce sterile hepatic immunity","volume":"595","author":"Mwakingwe-Omari","year":"2021"},{"key":"b11","year":"2022"},{"key":"b12","author":"Arifin","year":"2021"},{"key":"b13","year":"2021"}],"container-title":["The American Journal of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/110\/5\/article-p892.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/110\/5\/article-p892.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/110\/5\/article-p892.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T11:08:23Z","timestamp":1714561703000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/110\/5\/article-p892.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,1]]},"references-count":13,"journal-issue":{"issue":"5"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.23-0597","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,1]]}}}