Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls
The study assessed long-term immunopersistence and safety of the Escherichia coli (E. coli)-produced HPV-16/18 bivalent vaccine. In total, 979 participants in the initial immunogenicity noninferiority study, including girls aged 9-14 years who were randomized in a 1:1 ratio to receive 2 doses at mon...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2061248 |
| _version_ | 1797673207362224128 |
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| author | Xingmei Yao Wengang He Xianghong Wu Jianxiang Gu Jing Zhang Bizhen Lin Zhaofeng Bi Yingying Su Shoujie Huang Yuemei Hu Ting Wu Jun Zhang Ningshao Xia |
| author_facet | Xingmei Yao Wengang He Xianghong Wu Jianxiang Gu Jing Zhang Bizhen Lin Zhaofeng Bi Yingying Su Shoujie Huang Yuemei Hu Ting Wu Jun Zhang Ningshao Xia |
| author_sort | Xingmei Yao |
| collection | DOAJ |
| description | The study assessed long-term immunopersistence and safety of the Escherichia coli (E. coli)-produced HPV-16/18 bivalent vaccine. In total, 979 participants in the initial immunogenicity noninferiority study, including girls aged 9-14 years who were randomized in a 1:1 ratio to receive 2 doses at months 0 and 6 (n = 301) or 3 doses at months 0, 1 and 6 (n = 304); girls aged 15-17 years (n = 149) and women aged 18–26 years (n = 225) who received 3 doses of the vaccine, were invited to participate in follow-up to 30 months post vaccination (NCT03206255). Serum samples were collected at months 18 and 30, and anti-HPV-16/18 IgG antibodies were measured by enzyme-linked immunosorbent assay. Serious adverse events (SAEs) occurred from month 7 through month 30 were recorded. At month 30, in the per-protocol set, all participants remained seropositive, except for one girl in the 9-14 years (2 doses) group who seroconverted to negative for HPV-18. HPV-16 and HPV-18 antibody levels were higher in girls aged 9-17 years who received 3 doses (125.3 and 60.2 IU/ml) than in women aged 18-26 years who received 3 doses (72.6 and 28.3 IU/ml), and those in girls aged 9-14 years who received 2 doses (73.2 and 24.9 IU/ml) were comparable to those in women aged 18-26 years who received 3 doses. No SAEs were reported to be causally related to vaccination. The E. coli-produced bivalent HPV-16/18 vaccine is safe and induces persistent protective antibodies for up to 30 months after vaccination in girls aged 9-17 years receiving 2 or 3 doses. |
| first_indexed | 2024-03-11T21:40:59Z |
| format | Article |
| id | doaj.art-bd3c4a04d89f416c97bc94384f9686b2 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:40:59Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-bd3c4a04d89f416c97bc94384f9686b22023-09-26T13:19:06ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118510.1080/21645515.2022.20612482061248Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girlsXingmei Yao0Wengang He1Xianghong Wu2Jianxiang Gu3Jing Zhang4Bizhen Lin5Zhaofeng Bi6Yingying Su7Shoujie Huang8Yuemei Hu9Ting Wu10Jun Zhang11Ningshao Xia12Xiamen UniversityXiamen UniversitySheyang Center for Disease Control and PreventionSheyang Center for Disease Control and PreventionSheyang Center for Disease Control and PreventionXiamen Innovax Biotech CompanyXiamen UniversityXiamen UniversityXiamen UniversityJiangsu Provincial Center for Disease Control and PreventionXiamen UniversityXiamen UniversityXiamen UniversityThe study assessed long-term immunopersistence and safety of the Escherichia coli (E. coli)-produced HPV-16/18 bivalent vaccine. In total, 979 participants in the initial immunogenicity noninferiority study, including girls aged 9-14 years who were randomized in a 1:1 ratio to receive 2 doses at months 0 and 6 (n = 301) or 3 doses at months 0, 1 and 6 (n = 304); girls aged 15-17 years (n = 149) and women aged 18–26 years (n = 225) who received 3 doses of the vaccine, were invited to participate in follow-up to 30 months post vaccination (NCT03206255). Serum samples were collected at months 18 and 30, and anti-HPV-16/18 IgG antibodies were measured by enzyme-linked immunosorbent assay. Serious adverse events (SAEs) occurred from month 7 through month 30 were recorded. At month 30, in the per-protocol set, all participants remained seropositive, except for one girl in the 9-14 years (2 doses) group who seroconverted to negative for HPV-18. HPV-16 and HPV-18 antibody levels were higher in girls aged 9-17 years who received 3 doses (125.3 and 60.2 IU/ml) than in women aged 18-26 years who received 3 doses (72.6 and 28.3 IU/ml), and those in girls aged 9-14 years who received 2 doses (73.2 and 24.9 IU/ml) were comparable to those in women aged 18-26 years who received 3 doses. No SAEs were reported to be causally related to vaccination. The E. coli-produced bivalent HPV-16/18 vaccine is safe and induces persistent protective antibodies for up to 30 months after vaccination in girls aged 9-17 years receiving 2 or 3 doses.http://dx.doi.org/10.1080/21645515.2022.2061248human papillomavirusvaccineescherichia coli-producedadolescent girlimmunopersistence |
| spellingShingle | Xingmei Yao Wengang He Xianghong Wu Jianxiang Gu Jing Zhang Bizhen Lin Zhaofeng Bi Yingying Su Shoujie Huang Yuemei Hu Ting Wu Jun Zhang Ningshao Xia Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls Human Vaccines & Immunotherapeutics human papillomavirus vaccine escherichia coli-produced adolescent girl immunopersistence |
| title | Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls |
| title_full | Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls |
| title_fullStr | Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls |
| title_full_unstemmed | Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls |
| title_short | Long-Term immunopersistence and safety of the Escherichia coli-produced HPV-16/18 bivalent vaccine in Chinese adolescent girls |
| title_sort | long term immunopersistence and safety of the escherichia coli produced hpv 16 18 bivalent vaccine in chinese adolescent girls |
| topic | human papillomavirus vaccine escherichia coli-produced adolescent girl immunopersistence |
| url | http://dx.doi.org/10.1080/21645515.2022.2061248 |
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