Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months
ABSTRACT: Objectives: To evaluate the safety, immunogenicity, and lot-to-lot consistency of Sabin strain-based inactivated polio vaccine (sIPV) in a five-dose vial presentation. Methods: Stage I was an open-label safety observation, in which 72 healthy subjects (including 24 adults, children, and i...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-05-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223000206 |
| _version_ | 1797850531730817024 |
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| author | Guangwei Feng Deyu Jiang Weixiao Han Zhiqiang Xie Zhiwei Jiang Lili Huang Jianfeng Wang Wei Zhang Li Xu Jiebing Tan Wangyang You Guoliang Cui Changgui Li Yanxia Wang |
| author_facet | Guangwei Feng Deyu Jiang Weixiao Han Zhiqiang Xie Zhiwei Jiang Lili Huang Jianfeng Wang Wei Zhang Li Xu Jiebing Tan Wangyang You Guoliang Cui Changgui Li Yanxia Wang |
| author_sort | Guangwei Feng |
| collection | DOAJ |
| description | ABSTRACT: Objectives: To evaluate the safety, immunogenicity, and lot-to-lot consistency of Sabin strain-based inactivated polio vaccine (sIPV) in a five-dose vial presentation. Methods: Stage I was an open-label safety observation, in which 72 healthy subjects (including 24 adults, children, and infants each) were given one or three doses of the five-dose vial sIPV; stage II was a randomized, blinded, and positive-control study, in which 1500 infants were randomized at the ratio of 1: 1: 1: 1: 1 into five groups to receive either three doses of the five-dose sIPV three lots, a conventional inactivated poliovirus vaccine, or a single-dose sIPV as controls, for primary immunization. Safety, immunogenicity, and lot-to-lot consistency were assessed. Results: Among 1456 subjects who completed the primary immunization, the geometric mean titer ratios of types 1, 2, and 3 of each pair of lots were all within the equivalence criteria margin (0.67-1.50). The seroconversion rates of types 1, 2, and 3 in the combined test group were 98.02%, 94.07%, and 98.77%, respectively, which were noninferior to both control groups. The overall incidence of adverse reactions was 29.68% and erythema was the most common adverse reaction with incidences of 10.47%,9.33%, and 9.73% in the combined test group and control groups (P >0.05). Conclusion: The five-dose sIPV demonstrated good safety, immunogenicity, and lot-to-lot consistency. |
| first_indexed | 2024-04-09T19:01:32Z |
| format | Article |
| id | doaj.art-d0be7cecfa744464b5969ca6aebff923 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-04-09T19:01:32Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-d0be7cecfa744464b5969ca6aebff9232023-04-08T05:10:38ZengElsevierInternational Journal of Infectious Diseases1201-97122023-05-011302027Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 monthsGuangwei Feng0Deyu Jiang1Weixiao Han2Zhiqiang Xie3Zhiwei Jiang4Lili Huang5Jianfeng Wang6Wei Zhang7Li Xu8Jiebing Tan9Wangyang You10Guoliang Cui11Changgui Li12Yanxia Wang13Henan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaSinovac Life Sciences Co., Ltd. Beijing, ChinaSinovac Biotech Co., Ltd., Beijing, ChinaHenan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaBeijing Key Tech Statistics Technology, Beijing, 100025, ChinaHenan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaSinovac Biotech Co., Ltd., Beijing, ChinaHenan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaSinovac Biotech Co., Ltd., Beijing, ChinaHenan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaHenan Provincial Center for Disease Control and Prevention, Zhengzhou, ChinaSinovac Life Sciences Co., Ltd. Beijing, China; Corresponding authors: Tel: +86-53852132; Fax: +86-53852132National Institute for Food and Drug Control, Beijing, China; Corresponding authors: Tel: +86-53852132; Fax: +86-53852132Henan Provincial Center for Disease Control and Prevention, Zhengzhou, China; Corresponding authors: Tel: +86-53852132; Fax: +86-53852132ABSTRACT: Objectives: To evaluate the safety, immunogenicity, and lot-to-lot consistency of Sabin strain-based inactivated polio vaccine (sIPV) in a five-dose vial presentation. Methods: Stage I was an open-label safety observation, in which 72 healthy subjects (including 24 adults, children, and infants each) were given one or three doses of the five-dose vial sIPV; stage II was a randomized, blinded, and positive-control study, in which 1500 infants were randomized at the ratio of 1: 1: 1: 1: 1 into five groups to receive either three doses of the five-dose sIPV three lots, a conventional inactivated poliovirus vaccine, or a single-dose sIPV as controls, for primary immunization. Safety, immunogenicity, and lot-to-lot consistency were assessed. Results: Among 1456 subjects who completed the primary immunization, the geometric mean titer ratios of types 1, 2, and 3 of each pair of lots were all within the equivalence criteria margin (0.67-1.50). The seroconversion rates of types 1, 2, and 3 in the combined test group were 98.02%, 94.07%, and 98.77%, respectively, which were noninferior to both control groups. The overall incidence of adverse reactions was 29.68% and erythema was the most common adverse reaction with incidences of 10.47%,9.33%, and 9.73% in the combined test group and control groups (P >0.05). Conclusion: The five-dose sIPV demonstrated good safety, immunogenicity, and lot-to-lot consistency.http://www.sciencedirect.com/science/article/pii/S1201971223000206Sabin strainInactivated poliovirus vaccineLot-to-lot consistencyPhase-III trial |
| spellingShingle | Guangwei Feng Deyu Jiang Weixiao Han Zhiqiang Xie Zhiwei Jiang Lili Huang Jianfeng Wang Wei Zhang Li Xu Jiebing Tan Wangyang You Guoliang Cui Changgui Li Yanxia Wang Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months International Journal of Infectious Diseases Sabin strain Inactivated poliovirus vaccine Lot-to-lot consistency Phase-III trial |
| title | Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months |
| title_full | Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months |
| title_fullStr | Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months |
| title_full_unstemmed | Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months |
| title_short | Safety, immunogenicity, and lot-to-lot consistency of a multidose Sabin strain-based inactivated polio vaccine: a phase III, randomized, blinded, positive-control clinical trial in infants aged 2 months |
| title_sort | safety immunogenicity and lot to lot consistency of a multidose sabin strain based inactivated polio vaccine a phase iii randomized blinded positive control clinical trial in infants aged 2 months |
| topic | Sabin strain Inactivated poliovirus vaccine Lot-to-lot consistency Phase-III trial |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223000206 |
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