Eintrag weiter verarbeiten
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial...
Gespeichert in:
Zeitschriftentitel: | Cancer Medicine |
---|---|
Personen und Körperschaften: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
In: | Cancer Medicine, 8, 2019, 14, S. 6195-6211 |
Format: | E-Article |
Sprache: | Englisch |
veröffentlicht: |
Wiley
|
Schlagwörter: |
author_facet |
Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank |
---|---|
author |
Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank |
spellingShingle |
Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank Cancer Medicine Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial Cancer Research Radiology, Nuclear Medicine and imaging Oncology |
author_sort |
zhu, feng‐cai |
spelling |
Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank 2045-7634 2045-7634 Wiley Cancer Research Radiology, Nuclear Medicine and imaging Oncology http://dx.doi.org/10.1002/cam4.2399 <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Cervical cancer is a major public health concern in China. We report the end‐of‐study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04‐human papillomavirus (HPV)‐16/18 vaccine in Chinese women aged 18‐25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Healthy 18‐25‐year‐old women (N = 6051) were randomized (1:1) to receive three doses of AS04‐HPV‐16/18 vaccine or Al(OH)<jats:sub>3</jats:sub> (control) at Months 0‐1‐6. Vaccine efficacy against HPV‐16/18 infection and cervical intraepithelial neoplasia (CIN), cross‐protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according‐to‐protocol efficacy (ATP‐E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC‐E; vaccine N = 2987; control N = 2985) and TVC‐naïve (vaccine N = 1660; control N = 1587).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In initially HPV‐16/18 seronegative/DNA‐negative women, vaccine efficacy against HPV‐16/18‐associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP‐E, 88.7% (95% CI: 18.5, 99.7) in the TVC‐E, and 100% (95% CI: 17.9, 100) in the TVC‐naïve. Cross‐protective efficacy against incident infection with HPV‐31, HPV‐33 and HPV‐45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP‐E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti‐HPV‐16/18 antibodies; anti‐HPV‐16 and anti‐HPV‐18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This is the first large‐scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV‐16/18‐associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>NCT00779766.</jats:p></jats:sec> Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial Cancer Medicine |
doi_str_mv |
10.1002/cam4.2399 |
facet_avail |
Online Free |
finc_class_facet |
Medizin |
format |
ElectronicArticle |
fullrecord |
blob:ai-49-aHR0cDovL2R4LmRvaS5vcmcvMTAuMTAwMi9jYW00LjIzOTk |
id |
ai-49-aHR0cDovL2R4LmRvaS5vcmcvMTAuMTAwMi9jYW00LjIzOTk |
institution |
DE-15 DE-Rs1 DE-Pl11 DE-105 DE-14 DE-Ch1 DE-L229 DE-D275 DE-Bn3 DE-Brt1 DE-Zwi2 DE-D161 DE-Gla1 DE-Zi4 |
imprint |
Wiley, 2019 |
imprint_str_mv |
Wiley, 2019 |
issn |
2045-7634 |
issn_str_mv |
2045-7634 |
language |
English |
mega_collection |
Wiley (CrossRef) |
match_str |
zhu2019efficacyimmunogenicityandsafetyoftheas04hpv1618vaccineinchinesewomenaged1825yearsendofstudyresultsfromaphaseiiiiirandomisedcontrolledtrial |
publishDateSort |
2019 |
publisher |
Wiley |
recordtype |
ai |
record_format |
ai |
series |
Cancer Medicine |
source_id |
49 |
title |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_unstemmed |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_full |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_fullStr |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_full_unstemmed |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_short |
Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_sort |
efficacy, immunogenicity and safety of the as04‐hpv‐16/18 vaccine in chinese women aged 18‐25 years: end‐of‐study results from a phase ii/iii, randomised, controlled trial |
topic |
Cancer Research Radiology, Nuclear Medicine and imaging Oncology |
url |
http://dx.doi.org/10.1002/cam4.2399 |
publishDate |
2019 |
physical |
6195-6211 |
description |
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Cervical cancer is a major public health concern in China. We report the end‐of‐study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04‐human papillomavirus (HPV)‐16/18 vaccine in Chinese women aged 18‐25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Healthy 18‐25‐year‐old women (N = 6051) were randomized (1:1) to receive three doses of AS04‐HPV‐16/18 vaccine or Al(OH)<jats:sub>3</jats:sub> (control) at Months 0‐1‐6. Vaccine efficacy against HPV‐16/18 infection and cervical intraepithelial neoplasia (CIN), cross‐protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according‐to‐protocol efficacy (ATP‐E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC‐E; vaccine N = 2987; control N = 2985) and TVC‐naïve (vaccine N = 1660; control N = 1587).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In initially HPV‐16/18 seronegative/DNA‐negative women, vaccine efficacy against HPV‐16/18‐associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP‐E, 88.7% (95% CI: 18.5, 99.7) in the TVC‐E, and 100% (95% CI: 17.9, 100) in the TVC‐naïve. Cross‐protective efficacy against incident infection with HPV‐31, HPV‐33 and HPV‐45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP‐E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti‐HPV‐16/18 antibodies; anti‐HPV‐16 and anti‐HPV‐18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This is the first large‐scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV‐16/18‐associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>NCT00779766.</jats:p></jats:sec> |
container_issue |
14 |
container_start_page |
6195 |
container_title |
Cancer Medicine |
container_volume |
8 |
format_de105 |
Article, E-Article |
format_de14 |
Article, E-Article |
format_de15 |
Article, E-Article |
format_de520 |
Article, E-Article |
format_de540 |
Article, E-Article |
format_dech1 |
Article, E-Article |
format_ded117 |
Article, E-Article |
format_degla1 |
E-Article |
format_del152 |
Buch |
format_del189 |
Article, E-Article |
format_dezi4 |
Article |
format_dezwi2 |
Article, E-Article |
format_finc |
Article, E-Article |
format_nrw |
Article, E-Article |
_version_ |
1792346890135666688 |
geogr_code |
not assigned |
last_indexed |
2024-03-01T17:46:18.132Z |
geogr_code_person |
not assigned |
openURL |
url_ver=Z39.88-2004&ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fvufind.svn.sourceforge.net%3Agenerator&rft.title=Efficacy%2C+immunogenicity+and+safety+of+the+AS04%E2%80%90HPV%E2%80%9016%2F18+vaccine+in+Chinese+women+aged+18%E2%80%9025%C2%A0years%3A+End%E2%80%90of%E2%80%90study+results+from+a+phase+II%2FIII%2C+randomised%2C+controlled+trial&rft.date=2019-10-01&genre=article&issn=2045-7634&volume=8&issue=14&spage=6195&epage=6211&pages=6195-6211&jtitle=Cancer+Medicine&atitle=Efficacy%2C+immunogenicity+and+safety+of+the+AS04%E2%80%90HPV%E2%80%9016%2F18+vaccine+in+Chinese+women+aged+18%E2%80%9025%C2%A0years%3A+End%E2%80%90of%E2%80%90study+results+from+a+phase+II%2FIII%2C+randomised%2C+controlled+trial&aulast=Struyf&aufirst=Frank&rft_id=info%3Adoi%2F10.1002%2Fcam4.2399&rft.language%5B0%5D=eng |
SOLR | |
_version_ | 1792346890135666688 |
author | Zhu, Feng‐Cai, Hu, Shang‐Ying, Hong, Ying, Hu, Yue‐Mei, Zhang, Xun, Zhang, Yi‐Ju, Pan, Qin‐Jing, Zhang, Wen‐Hua, Zhao, Fang‐Hui, Zhang, Cheng‐Fu, Yang, Xiaoping, Yu, Jia‐Xi, Zhu, Jiahong, Zhu, Yejiang, Chen, Feng, Zhang, Qian, Wang, Hong, Wang, Changrong, Bi, Jun, Xue, Shiyin, Shen, Lingling, Zhang, Yan‐Shu, He, Yunkun, Tang, Haiwen, Karkada, Naveen, Suryakiran, Pemmaraju, Bi, Dan, Struyf, Frank |
author_facet | Zhu, Feng‐Cai, Hu, Shang‐Ying, Hong, Ying, Hu, Yue‐Mei, Zhang, Xun, Zhang, Yi‐Ju, Pan, Qin‐Jing, Zhang, Wen‐Hua, Zhao, Fang‐Hui, Zhang, Cheng‐Fu, Yang, Xiaoping, Yu, Jia‐Xi, Zhu, Jiahong, Zhu, Yejiang, Chen, Feng, Zhang, Qian, Wang, Hong, Wang, Changrong, Bi, Jun, Xue, Shiyin, Shen, Lingling, Zhang, Yan‐Shu, He, Yunkun, Tang, Haiwen, Karkada, Naveen, Suryakiran, Pemmaraju, Bi, Dan, Struyf, Frank, Zhu, Feng‐Cai, Hu, Shang‐Ying, Hong, Ying, Hu, Yue‐Mei, Zhang, Xun, Zhang, Yi‐Ju, Pan, Qin‐Jing, Zhang, Wen‐Hua, Zhao, Fang‐Hui, Zhang, Cheng‐Fu, Yang, Xiaoping, Yu, Jia‐Xi, Zhu, Jiahong, Zhu, Yejiang, Chen, Feng, Zhang, Qian, Wang, Hong, Wang, Changrong, Bi, Jun, Xue, Shiyin, Shen, Lingling, Zhang, Yan‐Shu, He, Yunkun, Tang, Haiwen, Karkada, Naveen, Suryakiran, Pemmaraju, Bi, Dan, Struyf, Frank |
author_sort | zhu, feng‐cai |
container_issue | 14 |
container_start_page | 6195 |
container_title | Cancer Medicine |
container_volume | 8 |
description | <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Cervical cancer is a major public health concern in China. We report the end‐of‐study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04‐human papillomavirus (HPV)‐16/18 vaccine in Chinese women aged 18‐25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Healthy 18‐25‐year‐old women (N = 6051) were randomized (1:1) to receive three doses of AS04‐HPV‐16/18 vaccine or Al(OH)<jats:sub>3</jats:sub> (control) at Months 0‐1‐6. Vaccine efficacy against HPV‐16/18 infection and cervical intraepithelial neoplasia (CIN), cross‐protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according‐to‐protocol efficacy (ATP‐E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC‐E; vaccine N = 2987; control N = 2985) and TVC‐naïve (vaccine N = 1660; control N = 1587).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In initially HPV‐16/18 seronegative/DNA‐negative women, vaccine efficacy against HPV‐16/18‐associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP‐E, 88.7% (95% CI: 18.5, 99.7) in the TVC‐E, and 100% (95% CI: 17.9, 100) in the TVC‐naïve. Cross‐protective efficacy against incident infection with HPV‐31, HPV‐33 and HPV‐45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP‐E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti‐HPV‐16/18 antibodies; anti‐HPV‐16 and anti‐HPV‐18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This is the first large‐scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV‐16/18‐associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>NCT00779766.</jats:p></jats:sec> |
doi_str_mv | 10.1002/cam4.2399 |
facet_avail | Online, Free |
finc_class_facet | Medizin |
format | ElectronicArticle |
format_de105 | Article, E-Article |
format_de14 | Article, E-Article |
format_de15 | Article, E-Article |
format_de520 | Article, E-Article |
format_de540 | Article, E-Article |
format_dech1 | Article, E-Article |
format_ded117 | Article, E-Article |
format_degla1 | E-Article |
format_del152 | Buch |
format_del189 | Article, E-Article |
format_dezi4 | Article |
format_dezwi2 | Article, E-Article |
format_finc | Article, E-Article |
format_nrw | Article, E-Article |
geogr_code | not assigned |
geogr_code_person | not assigned |
id | ai-49-aHR0cDovL2R4LmRvaS5vcmcvMTAuMTAwMi9jYW00LjIzOTk |
imprint | Wiley, 2019 |
imprint_str_mv | Wiley, 2019 |
institution | DE-15, DE-Rs1, DE-Pl11, DE-105, DE-14, DE-Ch1, DE-L229, DE-D275, DE-Bn3, DE-Brt1, DE-Zwi2, DE-D161, DE-Gla1, DE-Zi4 |
issn | 2045-7634 |
issn_str_mv | 2045-7634 |
language | English |
last_indexed | 2024-03-01T17:46:18.132Z |
match_str | zhu2019efficacyimmunogenicityandsafetyoftheas04hpv1618vaccineinchinesewomenaged1825yearsendofstudyresultsfromaphaseiiiiirandomisedcontrolledtrial |
mega_collection | Wiley (CrossRef) |
physical | 6195-6211 |
publishDate | 2019 |
publishDateSort | 2019 |
publisher | Wiley |
record_format | ai |
recordtype | ai |
series | Cancer Medicine |
source_id | 49 |
spelling | Zhu, Feng‐Cai Hu, Shang‐Ying Hong, Ying Hu, Yue‐Mei Zhang, Xun Zhang, Yi‐Ju Pan, Qin‐Jing Zhang, Wen‐Hua Zhao, Fang‐Hui Zhang, Cheng‐Fu Yang, Xiaoping Yu, Jia‐Xi Zhu, Jiahong Zhu, Yejiang Chen, Feng Zhang, Qian Wang, Hong Wang, Changrong Bi, Jun Xue, Shiyin Shen, Lingling Zhang, Yan‐Shu He, Yunkun Tang, Haiwen Karkada, Naveen Suryakiran, Pemmaraju Bi, Dan Struyf, Frank 2045-7634 2045-7634 Wiley Cancer Research Radiology, Nuclear Medicine and imaging Oncology http://dx.doi.org/10.1002/cam4.2399 <jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Cervical cancer is a major public health concern in China. We report the end‐of‐study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04‐human papillomavirus (HPV)‐16/18 vaccine in Chinese women aged 18‐25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Healthy 18‐25‐year‐old women (N = 6051) were randomized (1:1) to receive three doses of AS04‐HPV‐16/18 vaccine or Al(OH)<jats:sub>3</jats:sub> (control) at Months 0‐1‐6. Vaccine efficacy against HPV‐16/18 infection and cervical intraepithelial neoplasia (CIN), cross‐protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according‐to‐protocol efficacy (ATP‐E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC‐E; vaccine N = 2987; control N = 2985) and TVC‐naïve (vaccine N = 1660; control N = 1587).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In initially HPV‐16/18 seronegative/DNA‐negative women, vaccine efficacy against HPV‐16/18‐associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP‐E, 88.7% (95% CI: 18.5, 99.7) in the TVC‐E, and 100% (95% CI: 17.9, 100) in the TVC‐naïve. Cross‐protective efficacy against incident infection with HPV‐31, HPV‐33 and HPV‐45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP‐E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti‐HPV‐16/18 antibodies; anti‐HPV‐16 and anti‐HPV‐18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This is the first large‐scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV‐16/18‐associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>NCT00779766.</jats:p></jats:sec> Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial Cancer Medicine |
spellingShingle | Zhu, Feng‐Cai, Hu, Shang‐Ying, Hong, Ying, Hu, Yue‐Mei, Zhang, Xun, Zhang, Yi‐Ju, Pan, Qin‐Jing, Zhang, Wen‐Hua, Zhao, Fang‐Hui, Zhang, Cheng‐Fu, Yang, Xiaoping, Yu, Jia‐Xi, Zhu, Jiahong, Zhu, Yejiang, Chen, Feng, Zhang, Qian, Wang, Hong, Wang, Changrong, Bi, Jun, Xue, Shiyin, Shen, Lingling, Zhang, Yan‐Shu, He, Yunkun, Tang, Haiwen, Karkada, Naveen, Suryakiran, Pemmaraju, Bi, Dan, Struyf, Frank, Cancer Medicine, Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial, Cancer Research, Radiology, Nuclear Medicine and imaging, Oncology |
title | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_full | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_fullStr | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_full_unstemmed | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_short | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
title_sort | efficacy, immunogenicity and safety of the as04‐hpv‐16/18 vaccine in chinese women aged 18‐25 years: end‐of‐study results from a phase ii/iii, randomised, controlled trial |
title_unstemmed | Efficacy, immunogenicity and safety of the AS04‐HPV‐16/18 vaccine in Chinese women aged 18‐25 years: End‐of‐study results from a phase II/III, randomised, controlled trial |
topic | Cancer Research, Radiology, Nuclear Medicine and imaging, Oncology |
url | http://dx.doi.org/10.1002/cam4.2399 |