View in EDS

Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.

Saved in:
Bibliographic Details
Title: Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.
Authors: Zhao FH; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Wu T; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Hu YM; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Wei LH; Peking University People's Hospital, Beijing, China., Li MQ; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China., Huang WJ; National Institute for Food and Drug Control, Beijing, China., Chen W; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Huang SJ; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Pan QJ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Zhang X; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Hong Y; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China., Zhao C; Peking University People's Hospital, Beijing, China., Li Q; Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China., Chu K; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Jiang YF; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China., Li MZ; Peking University People's Hospital, Beijing, China., Tang J; Funing Center for Disease Control and Prevention, Funing, Jiangsu, China., Li CH; Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China., Guo DP; Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China., Ke LD; Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China., Wu X; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China., Yao XM; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Nie JH; National Institute for Food and Drug Control, Beijing, China., Lin BZ; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhao YQ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Guo M; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Zhao J; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China., Zheng FZ; Xiamen Innovax Biotech Xiamen, Fujian, China., Xu XQ; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China., Su YY; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Zhang QF; Xiamen Innovax Biotech Xiamen, Fujian, China., Sun G; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhu FC; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China., Li SW; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China., Li YM; Beijing Wantai Biological Pharmacy Enterprise, Beijing, China., Pan HR; Xiamen Innovax Biotech Xiamen, Fujian, China., Zhang J; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China. Electronic address: zhangj@xmu.edu.cn., Qiao YL; School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China., Xia NS; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China; Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences, China.
Source: The Lancet. Infectious diseases [Lancet Infect Dis] 2022 Dec; Vol. 22 (12), pp. 1756-1768. Date of Electronic Publication: 2022 Aug 26.
Publication Type: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Science Country of Publication: United States NLM ID: 101130150 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-4457 (Electronic) Linking ISSN: 14733099 NLM ISO Abbreviation: Lancet Infect Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
FullText Text:
  Availability: 0
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 36037823
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Zhao+FH%22">Zhao FH</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Wu+T%22">Wu T</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Hu+YM%22">Hu YM</searchLink>; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Wei+LH%22">Wei LH</searchLink>; Peking University People's Hospital, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Li+MQ%22">Li MQ</searchLink>; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.<br /><searchLink fieldCode="AU" term="%22Huang+WJ%22">Huang WJ</searchLink>; National Institute for Food and Drug Control, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Chen+W%22">Chen W</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Huang+SJ%22">Huang SJ</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Pan+QJ%22">Pan QJ</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Zhang+X%22">Zhang X</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Hong+Y%22">Hong Y</searchLink>; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Zhao+C%22">Zhao C</searchLink>; Peking University People's Hospital, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Li+Q%22">Li Q</searchLink>; Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, Guangdong, China.<br /><searchLink fieldCode="AU" term="%22Chu+K%22">Chu K</searchLink>; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Jiang+YF%22">Jiang YF</searchLink>; the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Li+MZ%22">Li MZ</searchLink>; Peking University People's Hospital, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Tang+J%22">Tang J</searchLink>; Funing Center for Disease Control and Prevention, Funing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Li+CH%22">Li CH</searchLink>; Xinmi Maternal and Child Health Hospital, Xinmi, Henan, China.<br /><searchLink fieldCode="AU" term="%22Guo+DP%22">Guo DP</searchLink>; Yangcheng Maternal and Child Health Hospital, Yangcheng, Shanxi, China.<br /><searchLink fieldCode="AU" term="%22Ke+LD%22">Ke LD</searchLink>; Fengning Hospital of Traditional Chinese Medicine, Fengning, Hebei, China.<br /><searchLink fieldCode="AU" term="%22Wu+X%22">Wu X</searchLink>; Liuzhou Center for Disease Control and Prevention, Liuzhou, Guangxi, China.<br /><searchLink fieldCode="AU" term="%22Yao+XM%22">Yao XM</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Nie+JH%22">Nie JH</searchLink>; National Institute for Food and Drug Control, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Lin+BZ%22">Lin BZ</searchLink>; Xiamen Innovax Biotech Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zhao+YQ%22">Zhao YQ</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Guo+M%22">Guo M</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zhao+J%22">Zhao J</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zheng+FZ%22">Zheng FZ</searchLink>; Xiamen Innovax Biotech Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Xu+XQ%22">Xu XQ</searchLink>; National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Su+YY%22">Su YY</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zhang+QF%22">Zhang QF</searchLink>; Xiamen Innovax Biotech Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Sun+G%22">Sun G</searchLink>; Xiamen Innovax Biotech Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zhu+FC%22">Zhu FC</searchLink>; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.<br /><searchLink fieldCode="AU" term="%22Li+SW%22">Li SW</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Li+YM%22">Li YM</searchLink>; Beijing Wantai Biological Pharmacy Enterprise, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Pan+HR%22">Pan HR</searchLink>; Xiamen Innovax Biotech Xiamen, Fujian, China.<br /><searchLink fieldCode="AU" term="%22Zhang+J%22">Zhang J</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China. Electronic address: zhangj@xmu.edu.cn.<br /><searchLink fieldCode="AU" term="%22Qiao+YL%22">Qiao YL</searchLink>; School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.<br /><searchLink fieldCode="AU" term="%22Xia+NS%22">Xia NS</searchLink>; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, Fujian, China; Xiang An Biomedicine Laboratory, Xiamen, Fujian, China; Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences, China.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22101130150%22">The Lancet. Infectious diseases</searchLink> [Lancet Infect Dis] 2022 Dec; Vol. 22 (12), pp. 1756-1768. <i>Date of Electronic Publication: </i>2022 Aug 26.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101130150 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1474-4457 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214733099%22">14733099 </searchLink><i>NLM ISO Abbreviation: </i>Lancet Infect Dis <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=36037823
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S1473-3099(22)00435-2
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 1756
    Titles:
      – TitleFull: Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Zhao FH
      – PersonEntity:
          Name:
            NameFull: Wu T
      – PersonEntity:
          Name:
            NameFull: Hu YM
      – PersonEntity:
          Name:
            NameFull: Wei LH
      – PersonEntity:
          Name:
            NameFull: Li MQ
      – PersonEntity:
          Name:
            NameFull: Huang WJ
      – PersonEntity:
          Name:
            NameFull: Chen W
      – PersonEntity:
          Name:
            NameFull: Huang SJ
      – PersonEntity:
          Name:
            NameFull: Pan QJ
      – PersonEntity:
          Name:
            NameFull: Zhang X
      – PersonEntity:
          Name:
            NameFull: Hong Y
      – PersonEntity:
          Name:
            NameFull: Zhao C
      – PersonEntity:
          Name:
            NameFull: Li Q
      – PersonEntity:
          Name:
            NameFull: Chu K
      – PersonEntity:
          Name:
            NameFull: Jiang YF
      – PersonEntity:
          Name:
            NameFull: Li MZ
      – PersonEntity:
          Name:
            NameFull: Tang J
      – PersonEntity:
          Name:
            NameFull: Li CH
      – PersonEntity:
          Name:
            NameFull: Guo DP
      – PersonEntity:
          Name:
            NameFull: Ke LD
      – PersonEntity:
          Name:
            NameFull: Wu X
      – PersonEntity:
          Name:
            NameFull: Yao XM
      – PersonEntity:
          Name:
            NameFull: Nie JH
      – PersonEntity:
          Name:
            NameFull: Lin BZ
      – PersonEntity:
          Name:
            NameFull: Zhao YQ
      – PersonEntity:
          Name:
            NameFull: Guo M
      – PersonEntity:
          Name:
            NameFull: Zhao J
      – PersonEntity:
          Name:
            NameFull: Zheng FZ
      – PersonEntity:
          Name:
            NameFull: Xu XQ
      – PersonEntity:
          Name:
            NameFull: Su YY
      – PersonEntity:
          Name:
            NameFull: Zhang QF
      – PersonEntity:
          Name:
            NameFull: Sun G
      – PersonEntity:
          Name:
            NameFull: Zhu FC
      – PersonEntity:
          Name:
            NameFull: Li SW
      – PersonEntity:
          Name:
            NameFull: Li YM
      – PersonEntity:
          Name:
            NameFull: Pan HR
      – PersonEntity:
          Name:
            NameFull: Zhang J
      – PersonEntity:
          Name:
            NameFull: Qiao YL
      – PersonEntity:
          Name:
            NameFull: Xia NS
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 12
              Text: 2022 Dec
              Type: published
              Y: 2022
          Identifiers:
            – Type: issn-electronic
              Value: 1474-4457
          Numbering:
            – Type: volume
              Value: 22
            – Type: issue
              Value: 12
          Titles:
            – TitleFull: The Lancet. Infectious diseases
              Type: main
ResultId 1