Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized,controlled, open-label,phase IV clinical trial in China |
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| Affiliation: | 1. China National Biotec Group Company Limited, Beijing, China;2. Inner Mongolia Autonomous Region Disease Prevention and Control Center, Huhhot, China;3. Shanxi Provincial Center for Disease Control and Prevention, Taiyuan, China;4. Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China;5. Beijing Institute of Biological Products Company Limited, Beijing, China;1. Department of Pediatrics, Institute of Postgraduate Education, I. Horbachevsky Ternopil National Medical University, Ukraine;2. Department of Internal Medicine, I. Horbachevsky Ternopil National Medical University and “Multysono” Medical Center, Ternopil, Ukraine;1. Serum Institute of India Private Ltd, 212/2, Off Soli Poonawalla Road, Hadapsar, Pune, Maharashtra 411028, India;2. Viroclinics Xplore, Viroclinics Biosciences B.V. Nistelrooise Baan 3, 5374RE Schaijk, the Netherlands;3. PATH, 2201 Westlake Avenue, Seattle, WA 98121, USA;1. Jiangsu Provincial Centre of Disease Control and Prevention, Jiangsu Province, China;2. Beijing Tiantan Biological Products Co., Ltd, Beijing, China;3. Chinese Centre of Disease Control and Prevention, Beijing, China;4. Xiangshui County Centre of Disease Control and Prevention, Jiangsu Province, China;1. Clinical Trials Assessment Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China;2. Division of Respiratory Virus Vaccines, National Institutes for Food and Drug Control, Beijing 102629, China;3. Clinical Research Department, Sinovac Biotech Co., LTD., Beijing 100085, China;1. Instituto de Medicina Experimental (IMEX)-Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Academia Nacional de Medicina, J.A. Pacheco de Melo 3081, CABA, 1425, Buenos Aires, Argentina;2. Instituto de Investigaciones Hematológicas (IIHEMA), Academia Nacional de Medicina, J.A. Pacheco de Melo 3081, CABA, 1425, Buenos Aires, Argentina;3. Instituto de Investigaciones Epidemiológicas (IIE), Academia Nacional de Medicina, J.A. Pacheco de Melo 3081, CABA, 1425, Buenos Aires, Argentina;1. Department of Infectious Disease Surveillance Center, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku, Tokyo 162-8640, Japan;2. Department of Virology II, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan;3. Hokkaido Institute of Public Health, North-19, West-12, Kita-ku, Sapporo, Hokkaido 060-0819, Japan;4. Yamagata Prefectural Institute of Public Health, 1-6-6 Tokamachi, Yamagata, Yamagata 990-0031, Japan;5. Gunma Prefectural Institute of Public Health and Environmental Sciences, 378 Kamiokimachi, Maebashi, Gunma 371-0052, Japan;6. Chiba Prefectural Institute of Public Health, 666-2 Nitonacho, Chuo-ku, Chiba, Chiba 260-8715, Japan;7. Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku, Tokyo 169-0073, Japan;8. Toyama Institute of Health, 17-1 Nakataikoyama, Imizu, Toyama 939-0363, Japan;9. Aichi Prefectural Institute of Public Health, 7-6 Nagare, Tsujicho, Kita-ku, Nagoya, Aichi 462-8576, Japan;10. Yamaguchi Prefectural Institute of Public Health and Environment, 2-5-67 Aoi, Yamaguchi, Yamaguchi 753-0821, Japan;11. Ehime Prefectural Institute of Public Health and Environmental Science, 8-234 Sanbancho, Matsuyama, Ehime 790-0003, Japan |
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| Abstract: | BackgroundThe immunogenicity and safety of the sequential schedule of Sabin strain-based inactivated poliovirus vaccine (sIPV) and bivalent oral poliovirus vaccine (bOPV) remains poorly understood in Chinese population.MethodsA multi-center, open-label, randomized controlled trial was performed involving 648 healthy infants aged 2 months from Inner Mongolia, Shanxi, and Hebei provinces. These participants were divided into three groups: sIPV-bOPV-bOPV, sIPV-sIPV-bOPV, and sIPV-sIPV-sIPV. Doses were administered sequentially at age 2, 3, and 4 months. Neutralisation assays were tested using sera collected at 2 months and 5 months.ResultsA total of 569 were included in the per-protocol analysis. The seroconversion rates of poliovirus type 1 and 3 were 100% in all three groups, the seroconversion rate of poliovirus type 2 was 91.53% (173/189) (95% CI: 86.62–95.08) in the sIPV-bOPV-bOPV group, 98.38% (182/185) (95% CI: 95.33–99.66) in the sIPV-sIPV-bOPV group, and 99.49% (194/195) (95% CI: 97.18–99.99) in the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus types 1 and 3, the sIPV-bOPV-bOPV and sIPV-sIPV-bOPV groups were non-inferior to the sIPV-sIPV-sIPV group. For the seroconversion rate of poliovirus type 2, the sIPV-sIPV-bOPV group was non-inferior to the sIPV-sIPV-sIPV group, and the sIPV-bOPV-bOPV group was inferior to the sIPV-sIPV-sIPV group. All three groups exhibited good safety, with two serious adverse events reported, that were unrelated to vaccine.ConclusionsIn china, a new vaccination schedule that including 2 doses of IPV in the national immunization programs is essential.Trial registration ClinicalTrials.govNCT04054492. |
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| Keywords: | Poliovirus Sabin strain Inactivated poliovirus vaccine Bivalent oral poliovirus vaccine |
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