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Koesnoe S.; Medise B.E.; Rengganis I.; Hadinegoro S.R.; Puspita M.; Sari R.M.; Yang J.S.; Sahastrabuddhe S.; Soedjatmiko; Gunardi H.; Sekartini R.; Wirahmadi A.; Kekalih A.; Mukhi S.; Satari H.I.; Bachtiar N.S. |
Koesnoe, Sukamto (26028015000); Medise, Bernie Endyarni (57226215370); Rengganis, Iris (8449988000); Hadinegoro, Sri Rezeki (57226218772); Puspita, Mita (57972960900); Sari, Rini Mulia (57191341371); Yang, Jae Seung (9738195400); Sahastrabuddhe, Sushant (59157739100); Soedjatmiko (56510278500); Gunardi, Hartono (56510252700); Sekartini, Rini (50162572300); Wirahmadi, Angga (57215184865); Kekalih, Aria (55633562200); Mukhi, Sreshta (58865425300); Satari, Hindra Irawan (57226214366); Bachtiar, Nov |
26028015000; 57226215370; 8449988000; 57226218772; 57972960900; 57191341371; 9738195400; 59157739100; 56510278500; 56510252700; 50162572300; 57215184865; 55633562200; 58865425300; 57226214366; 54879388400 |
A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity |
2024 |
Tropical Diseases, Travel Medicine and Vaccines |
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-85184141503&doi=10.1186%2fs40794-023-00210-z&partnerID=40&md5=edfdeeb086fab347d3a48efdc7a44d1f |
Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia; Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Community Medicine Department, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia; PT. Bio Farma, Bandung, Indonesia; International Vaccine Institute, Seoul, South Korea |
Koesnoe S., Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia; Medise B.E., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Rengganis I., Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia; Hadinegoro S.R., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Puspita M., PT. Bio Farma, Bandung, Indonesia; Sari R.M., PT. Bio Farma, Bandung, Indonesia; Yang J.S., International Vaccine Institute, Seoul, South Korea; Sahastrabuddhe S., International Vaccine Institute, Seoul, South Korea; Soedjatmiko, Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Gunardi H., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Sekartini R., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Wirahmadi A., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Kekalih A., Community Medicine Department, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia; Mukhi S., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Satari H.I., Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro no 71, Jakarta, 10340, Indonesia; Bachtiar N.S., PT. Bio Farma, Bandung, Indonesia |
Background: Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age. Methods: Subjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days. Results: Subjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001). Conclusions: Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years. Trial registration: Approved by ClinicalTrials.gov. Clinical trial registration number: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 . © 2024, The Author(s). |
Typhoid conjugate vaccine; Typhoid Fever; Vi-DT; Vi-PS |
conjugate vaccine; typhoid vaccine; adolescent; adolescent health; adult; Article; blood sampling; child; clinical effectiveness; clinical evaluation; controlled study; drug effect; drug safety; female; fever; gastrointestinal infection; human; human experiment; immunogenicity; Indonesian; infection prevention; male; myalgia; normal human; observational study; phase 2 clinical trial; randomized controlled trial; respiratory tract infection; seroconversion; systemic disease; typhoid fever; vaccination |
Amelia Rahman; Meily Uli Artha Harianja |
The authors acknowledge the following colleagues for their contributions to this study: dr. Otty Mitha Sevianti, SpA, dr. Kania Adhyanisitha, SpA, Emi Triana Putri, SKM, Dita Rachmalia, Amd.Kom, Yuni Yudha Aprilia, Amd.Keb, Romy Fadylla SE and Amelia Rahman, SE. Also, to the staff of Senen primary health center, drg. Lindawati, MKes, dr. Anna Hasnaini, dr. Edwinaditya Sekar Putri, Ifan Hanafi, Amd |
BioMed Central Ltd |
20550936 |
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