Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children
| العنوان: | Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children |
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| المؤلفون: | Sadiki Ismael, Joe Cohen, Eleanor M. Riley, Anangisye Malabeja, Marc Lievens, Karin Hallez, Jayne Gould, Tonya Villafana, Yolanda Guerra, Salum Msham, Barbara Savarese, Kevin Marsh, Ally Olotu, Neema Mturi, Martha M. Lemnge, Ken Awuondo, Trudie Lang, Omar Abdul, Amanda J. Leach, Lincoln Malle, John Lusingu, Patricia Njuguna, Chris Drakeley, Samwel Gesase, Johan Vekemans, Raimos Olomi, Sarah Benns, Philip Bejon, Aurélie Olivier, Denise Dekker, W. Ripley Ballou, Lorenz von Seidlein |
| المصدر: | PLoS ONE, Vol 5, Iss 11, p e14090 (2010) PLoS ONE |
| بيانات النشر: | Public Library of Science, 2010. |
| سنة النشر: | 2010 |
| مصطلحات موضوعية: | Pediatrics, medicine.medical_specialty, Fever, Plasmodium falciparum, Pediatrics and Child Health, Public Health and Epidemiology/Infectious Diseases, Pain, lcsh:Medicine, Tanzania, Rabies vaccine, Double-Blind Method, Malaria Vaccines, parasitic diseases, medicine, Humans, Malaria, Falciparum, Adverse effect, lcsh:Science, Vaccines, Multidisciplinary, Malaria vaccine, business.industry, Vaccination, lcsh:R, RTS,S, Infant, Alanine Transaminase, Public Health and Epidemiology/Global Health, Pneumonia, medicine.disease, Kenya, Gastroenteritis, Tolerability, Rabies Vaccines, Creatinine, Immunology, Rabies, lcsh:Q, Sleep Stages, business, Malaria, medicine.drug, Research Article, Infectious Diseases/Tropical and Travel-Associated Diseases |
| الوصف: | The malaria vaccine candidate, RTS,S/AS01E, showed promising protective efficacy in a trial of Kenyan and Tanzanian children aged 5 to 17 months. Here we report on the vaccine's safety and tolerability. The experimental design was a Phase 2b, two-centre, double-blind (observer- and participant-blind), randomised (1∶1 ratio) controlled trial. Three doses of study or control (rabies) vaccines were administered intramuscularly at 1 month intervals. Solicited adverse events (AEs) were collected for 7 days after each vaccination. There was surveillance and reporting for unsolicited adverse events for 30 days after each vaccination. Serious adverse events (SAEs) were recorded throughout the study period which lasted for 14 months after dose 1 in Korogwe, Tanzania and an average of 18 months post-dose 1 in Kilifi, Kenya. Blood samples for safety monitoring of haematological, renal and hepatic functions were taken at baseline, 3, 10 and 14 months after dose 1. A total of 894 children received RTS,S/AS01E or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01E had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01E recipient and nine episodes among eight rabies vaccine recipients met the criteria for severe malaria. Unsolicited AEs were reported in 78% of subjects in the RTS,S/AS01E group and 74% of subjects in the rabies vaccine group. In both vaccine groups, gastroenteritis and pneumonia were the most frequently reported unsolicited AE. Fever was the most frequently observed solicited AE and was recorded after 11% of RTS,S/AS01E doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01E showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01E will become available from the Phase 3 programme. Trial Registration ClinicalTrials.gov NCT00380393 |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0038-0393 1932-6203 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::94c48c4445f4752f3bedfc5717a37071 https://researchonline.lshtm.ac.uk/id/eprint/1221/1/Safety-of-the-Malaria-Vaccine-Candidate.PDF |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....94c48c4445f4752f3bedfc5717a37071 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00380393 19326203 |
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