Safety and immunogenicity of a bivalent HPV16/18 vaccine in Chinese females
As global supply is still inadequate to address the worldwide requirements for HPV vaccines, we assessed the safety and immunogenicity of a new bivalent HPV16/18 vaccine. In this randomized, double-blind, placebo-controlled, phase 2 trial, healthy 9-45-year-old Chinese females in three age cohorts (600 aged 9-17 years; 240 aged 18-26 years; 360 aged 27-45 years) were randomized 1:1 to receive three doses (0,2,6 months) of HPV16/18 vaccine or placebo. We measured neutralizing antibodies against HPV 16 and 18 at 7 months and monitored safety to 12 months in all age cohorts; 9-17-year-old girls were monitored for safety and immunogenicity to 48 months. In vaccinees, 99.8% seroconverted for HPV 16 and 18 types at 7 months; respective GMTs of 5827 (95% CI: 5249, 6468) and 4223 (3785, 4713) were significantly (p < .001) higher than controls for all comparisons. GMTs in the 9-17-year-olds, which were significantly higher than in older women at 7 months, gradually declined to 48 months but remained higher than placebo with seropositivity rates maintained at 98.5% and 97.6% against HPV 16 and 18, respectively. Adverse events occurred at similar rates after vaccine and placebo (69.8% vs. 72.5%, p = .308), including solicited local reactions and systemic adverse events which were mainly mild-to-moderate. The bivalent HPV16/18 vaccine was well tolerated and induced high levels of neutralizing antibodies in all age groups which persisted at high levels to 48 months in the 9-17-year-old age group which would be the target for HPV vaccination campaigns.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
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| Enthalten in: |
Human vaccines & immunotherapeutics - 19(2023), 1 vom: 31. Dez., Seite 2209001 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shi, Li-Wei [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 30.06.2023 Date Revised 01.07.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/21645515.2023.2209001 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357514785 |
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| 100 | 1 | |a Shi, Li-Wei |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and immunogenicity of a bivalent HPV16/18 vaccine in Chinese females |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 30.06.2023 | ||
| 500 | |a Date Revised 01.07.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a As global supply is still inadequate to address the worldwide requirements for HPV vaccines, we assessed the safety and immunogenicity of a new bivalent HPV16/18 vaccine. In this randomized, double-blind, placebo-controlled, phase 2 trial, healthy 9-45-year-old Chinese females in three age cohorts (600 aged 9-17 years; 240 aged 18-26 years; 360 aged 27-45 years) were randomized 1:1 to receive three doses (0,2,6 months) of HPV16/18 vaccine or placebo. We measured neutralizing antibodies against HPV 16 and 18 at 7 months and monitored safety to 12 months in all age cohorts; 9-17-year-old girls were monitored for safety and immunogenicity to 48 months. In vaccinees, 99.8% seroconverted for HPV 16 and 18 types at 7 months; respective GMTs of 5827 (95% CI: 5249, 6468) and 4223 (3785, 4713) were significantly (p < .001) higher than controls for all comparisons. GMTs in the 9-17-year-olds, which were significantly higher than in older women at 7 months, gradually declined to 48 months but remained higher than placebo with seropositivity rates maintained at 98.5% and 97.6% against HPV 16 and 18, respectively. Adverse events occurred at similar rates after vaccine and placebo (69.8% vs. 72.5%, p = .308), including solicited local reactions and systemic adverse events which were mainly mild-to-moderate. The bivalent HPV16/18 vaccine was well tolerated and induced high levels of neutralizing antibodies in all age groups which persisted at high levels to 48 months in the 9-17-year-old age group which would be the target for HPV vaccination campaigns | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a HPV | |
| 650 | 4 | |a Human papilloma virus | |
| 650 | 4 | |a immunogenicity | |
| 650 | 4 | |a neutralizing antibodies | |
| 650 | 4 | |a reactogenicity | |
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| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Papillomavirus Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Combined |2 NLM | |
| 700 | 1 | |a Li, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Bang-Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Li-Rong |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Ke |e verfasserin |4 aut | |
| 700 | 1 | |a Ji, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Ling-Yun |e verfasserin |4 aut | |
| 700 | 1 | |a Yuan, Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Shu-Yuan |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jing-Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Ling |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Zhi-Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Rong-Cheng |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Yan-Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Xia, Jie-Lai |e verfasserin |4 aut | |
| 700 | 1 | |a Mo, Zhao-Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Chang-Gui |e verfasserin |4 aut | |
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