Interchangeability of two Enterovirus 71 inactivated vaccines in Chinese children: A phase IV,open-label,and randomized controlled trial |
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| Institution: | 1. Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, China;2. Academy of Preventive Medicine, Shandong University, Jinan, China;3. Rushan City Center for Disease Control and Prevention, Rushan, Shandong, China;4. Sinovac Biotech Co., Ltd., Beijing, China;1. Universidad de Buenos Aires, Facultad de Farmacia y Bioquímica, Instituto de Investigaciones en Bacteriología y Virología Molecular (IBaViM), Buenos Aires, Argentina;2. Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Ciudad Autónoma de Buenos Aires, Argentina;3. Fundación Hemocentro, Ciudad Autónoma de Buenos Aires, Argentina;4. Centro Regional de Hemoterapia Jujuy, San Salvador de Jujuy, Jujuy, Argentina;5. Centro Regional de Hemoterapia de Mendoza, Mendoza, Mendoza, Argentina;6. Hospital Regional Rio Grande, Rio Grande, Tierra del Fuego, Argentina;7. Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Córdoba, Córdoba, Argentina;8. Fundación Banco Central de Sangre, Córdoba, Córdoba, Argentina;9. Sección Virología, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno “CEMIC”, Ciudad Autónoma de Buenos Aires, Argentina;10. Instituto de Investigaciones Biomédicas en Retrovirus y Síndrome de Inmunodeficiencia Adquirida (INBIRS)-Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Universidad de Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina;1. Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming 650118, China;2. Aimei Convac BioPharm (Jiangsu) Co., Ltd., Taizhou 225300, Jiangsu, China;1. National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam;2. The Research Foundation for Microbial Diseases of Osaka University, Japan;3. Vietnam Research Station, Center for Infectious Disease Research in Asia and Africa, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan;4. Hanoi Medical University, Hanoi, Viet Nam;5. National Children’s Hospital, Hanoi, Viet Nam;6. Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan |
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| Abstract: | BackgroundIn China, three inactivated Enterovirus 71 (EV71) vaccines have been approved. Although the vaccines in an immunization series should be from a single manufacture, children sometimes have to receive EV71 vaccines from more than one manufacturers. The aim of this study was to evaluate the interchangeability and safety of vaccination with EV71 vaccines from two manufacturers among Chinese children.MethodsWe conducted an open label and randomized controlled study among children aged 6–35 months from November 2018 to January 2019. The participants were randomly assigned (1:1:1:1) to receive EV71 vaccines in one of the four different schedules (two using a single vaccine for all doses from one manufacture, and two mixed schedules using vaccines from two manufactures). Blood samples were collected pre-vaccination (Day 0) and one month after the second dose (Day 60) for neutralizing antibody assay. Immunogenicity was assessed in the per-protocol cohort and safety was assessed in the total vaccinated cohort.ResultsA total of 300 children were enrolled and randomized, of whom 89.0% (267/300) were included in the per-protocol cohort for immunogenicity analysis. The seroconversion rates of the EV71 neutralizing antibody in four groups ranged from 98.4% to 100.0%, and were not significantly different among the groups. Compared with other groups, geometric mean titer was higher in group D, in which the participants received Institute of Medical Biology Chinese Academy of Medical Sciences (CAMS) vaccine in the first dose and the Sinovac vaccine in the second dose. Safety profiles were similar among the four groups and no serious adverse events related to the vaccination were reported.ConclusionsInterchangeability of EV71 vaccines from two manufactures to complete an immunization series showed good immunogenicity and safety. The antibody response levels may vary by vaccination sequences of EV71 vaccines from the two manufacturers.Trial registration: ClinicalTrials.govNCT03873740. |
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| Keywords: | Interchangeability EV71 vaccine Immunogenicity Safety |
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