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Publikasi Scopus 2024 per tanggal 30 Juni 2024 (499 artikel)
Publikasi Scopus 2024 per tanggal 30 Juni 2024 (499 artikel)
Indrihutami, Khoriah (59019138700); Chand, Krisin (15077006400); Fahmia, Rizka (59019138800); Rahardjani, Mutia (57397771600); Wulandari, Fitria (57397960200); Subekti, Decy (6603632507); Noviyanti, Rintis (6508241752); Soebandrio, Amin (8602893200); Mallisa, Noch T. (59015864400); Mardika, I. Made (59018327200); Budiman, Waras (57219944920); Suriswan, Irwan (59019961900); Ertanto, Yogi (57211856711); Chen, Mei-Chun (57679115300); Murshedkar, Tooba (57189236512); Abebe, Yonas (56472623000); Sim,
Implementation of a Randomized, Placebo-Controlled Trial of Live Attenuated Malaria Sporozoite Vaccines in an Indonesian Military Study Population
2024
American Journal of Tropical Medicine and Hygiene
110
5
892
901
9
0
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85192113869&doi=10.4269%2fajtmh.23-0597&partnerID=40&md5=b584381f8da125e76cef7c164bcbc56b
Oxford University Clinical Research Unit Indonesia, Jakarta, Indonesia; Eijkman Research Center for Molecular Biology, National Research & Innovation Agency, West Java, Cibinong, Indonesia; EXEINS Health Initiative, Jakarta, Indonesia; Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Presidential Staff Office, Republic of Indonesia, Jakarta, Indonesia; Gatot Soebroto Army Hospital, Jakarta, Indonesia; Muhammadiyah University, East Java, Surabaya, Indonesia; Army Medical Center, Army of the Republic of Indonesia, Jakarta, Indonesia; Sanaria Inc., Rockville, MD, United States; StatPlus, Inc, Taipei, Taiwan; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom; Division of Tropical Medicine and Infectious Disease, Department of Internal Medicine, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
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, SanariaVR 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. © 2024 The author(s)
Adult; Female; Humans; Indonesia; Malaria Vaccines; Malaria, Falciparum; Malaria, Vivax; Male; Military Personnel; Plasmodium falciparum; Plasmodium vivax; Sporozoites; Vaccines, Attenuated; Young Adult; chloroquine; live vaccine; malaria vaccine; placebo; sporozoite vaccine; live vaccine; malaria vaccine; adult; Article; clinical monitoring; clinical outcome; controlled study; disease transmission; double blind procedure; drug efficacy; drug exposure; drug safety; drug tolerability; eligibility; follow up; health care planning; human; immunization; incidence; Indonesian; informed consent; interpersonal communication; major clinical study; malaria falciparum; male; middle aged; military deployment; military personnel; phase 2 clinical trial; Plasmodium vivax malaria; randomization; randomi
Congressionally Directed Medical Research Programs, CDMRP
Financial support: This research is funded by an award from the Congressionally Directed Medical Research Program (CDMRP) to Sanaria Inc. and clinical trial agreement with University of Oxford. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the CDMRP.
American Society of Tropical Medicine and Hygiene
00029637
38531102
Article
Q1
1042
3942