A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine
This phase Ⅱ, randomized, controlled trial aimed to evaluate the safety and immunogenicity of a various Sabin IPV preparations. Six hundred infants aged 60 ~ 90 days received one of five different vaccines: low- (group A), medium- (group B) or high-D antigen content (group C) of an experimental Sabi...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2020.1745593 |
| _version_ | 1797677274042990592 |
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| author | Rong Tang Guifan Li Chengfu Zhang Hengkui Zhi Jiahong Zhu Jianjun Wang Qi Liang Yuemei Hu Changgui Li |
| author_facet | Rong Tang Guifan Li Chengfu Zhang Hengkui Zhi Jiahong Zhu Jianjun Wang Qi Liang Yuemei Hu Changgui Li |
| author_sort | Rong Tang |
| collection | DOAJ |
| description | This phase Ⅱ, randomized, controlled trial aimed to evaluate the safety and immunogenicity of a various Sabin IPV preparations. Six hundred infants aged 60 ~ 90 days received one of five different vaccines: low- (group A), medium- (group B) or high-D antigen content (group C) of an experimental Sabin IPV, control Sabin IPV (group D) or control Salk IPV (group E), on a 0-1-2 month schedule. Participants were observed and followed up within 30 days of each dose to assess safety. Serum samples were collected before the first dose and 30 days after the third dose to assess immunogenicity. After three doses, type-1 seroconversion rates of groups A–E were 99.1%, 100.0%, 99.1%, 99.0%, and 93.4%, respectively; type-2 seroconversion rates were 93.5%, 97.1%, 98.1%, 95.1%, and 91.5%, respectively; and type-3 seroconversion rates were 95.4%, 98.1%, 98.1%, 95.1%, and 100.0%, respectively. Only type-1 seroconversion rates differed significantly for group E. The incidences of injection-site redness (A: 21.9%, B: 23.7%, C: 29.4%, D: 16.2%, E: 12.7%), swelling (A: 6.7%, B: 6.8%, C: 5.0%, D: 0.0%, E: 1.7%) and pain (A: 5.0%, B: 6.8%, C: 7.6%, D: 0.0%, E: 0.9%) all were significantly higher for experimental vaccines relative to control groups. No SAEs were detected related to vaccination, and most adverse reactions were mild or moderate in severity. In conclusion, the experimental Sabin IPVs with low-, medium-, and high-D antigen content all revealed good safety and immunogenicity profiles although being more reactogenic than the control vaccines. |
| first_indexed | 2024-03-11T22:42:59Z |
| format | Article |
| id | doaj.art-44da982d72d74e018d7e26b74175e17e |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:42:59Z |
| publishDate | 2020-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-44da982d72d74e018d7e26b74175e17e2023-09-22T08:51:48ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-11-0116112641264810.1080/21645515.2020.17455931745593A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccineRong Tang0Guifan Li1Chengfu Zhang2Hengkui Zhi3Jiahong Zhu4Jianjun Wang5Qi Liang6Yuemei Hu7Changgui Li8Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)Beijing Minhai Biotechnology Co. LtdLianshui County Center for Disease Control and PreventionDafeng County Center for Disease Control and PreventionLianshui County Center for Disease Control and PreventionDafeng County Center for Disease Control and PreventionJiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)National Institute for Food and Drug ControlThis phase Ⅱ, randomized, controlled trial aimed to evaluate the safety and immunogenicity of a various Sabin IPV preparations. Six hundred infants aged 60 ~ 90 days received one of five different vaccines: low- (group A), medium- (group B) or high-D antigen content (group C) of an experimental Sabin IPV, control Sabin IPV (group D) or control Salk IPV (group E), on a 0-1-2 month schedule. Participants were observed and followed up within 30 days of each dose to assess safety. Serum samples were collected before the first dose and 30 days after the third dose to assess immunogenicity. After three doses, type-1 seroconversion rates of groups A–E were 99.1%, 100.0%, 99.1%, 99.0%, and 93.4%, respectively; type-2 seroconversion rates were 93.5%, 97.1%, 98.1%, 95.1%, and 91.5%, respectively; and type-3 seroconversion rates were 95.4%, 98.1%, 98.1%, 95.1%, and 100.0%, respectively. Only type-1 seroconversion rates differed significantly for group E. The incidences of injection-site redness (A: 21.9%, B: 23.7%, C: 29.4%, D: 16.2%, E: 12.7%), swelling (A: 6.7%, B: 6.8%, C: 5.0%, D: 0.0%, E: 1.7%) and pain (A: 5.0%, B: 6.8%, C: 7.6%, D: 0.0%, E: 0.9%) all were significantly higher for experimental vaccines relative to control groups. No SAEs were detected related to vaccination, and most adverse reactions were mild or moderate in severity. In conclusion, the experimental Sabin IPVs with low-, medium-, and high-D antigen content all revealed good safety and immunogenicity profiles although being more reactogenic than the control vaccines.http://dx.doi.org/10.1080/21645515.2020.1745593inactivated poliovirus vaccinesabin strainphase ⅱ trialsafetyimmunogenicity |
| spellingShingle | Rong Tang Guifan Li Chengfu Zhang Hengkui Zhi Jiahong Zhu Jianjun Wang Qi Liang Yuemei Hu Changgui Li A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine Human Vaccines & Immunotherapeutics inactivated poliovirus vaccine sabin strain phase ⅱ trial safety immunogenicity |
| title | A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine |
| title_full | A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine |
| title_fullStr | A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine |
| title_full_unstemmed | A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine |
| title_short | A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine |
| title_sort | phase ii randomized controlled trial to evaluate the safety and immunogenicity of a sabin strain based inactivated polio vaccine |
| topic | inactivated poliovirus vaccine sabin strain phase ⅱ trial safety immunogenicity |
| url | http://dx.doi.org/10.1080/21645515.2020.1745593 |
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