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Research Paper

Lot-to-lot consistency study of an Escherichia coli-produced bivalent human papillomavirus vaccine in adult women: a randomized trial

Ying-Ying Sua The 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, ChinaView further author information

Bi-Zhen Linb Vaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, ChinaView further author information

Hui Zhaoc National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines, Beijing, ChinaView further author information

Juan Lic National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines, Beijing, ChinaView further author information

Zhi-Jie Linb Vaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, ChinaView further author information

You-Lin Qiaod National Cancer Center, National Center for Cancer Clinical Research, the Cancer Institute, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, ChinaView further author information

Li-Hui Weie Department of Obstetrics and Gynecology, Peking University People’s Hospital, Beijing, ChinaView further author information

Yue-Mei Huf Department of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, ChinaView further author information

Rong-Cheng Lig Center for Vaccine Clinical Research, Guangxi Center for Disease Control and Prevention, Nanning, Guangxi, ChinaView further author information

Si-Jie Zhuanga The 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, ChinaView further author information

Guang Sunb Vaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, ChinaView further author information

Zi-Zheng Zhenga The 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, ChinaView further author information

Shou-Jie Huanga The 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, ChinaView further author information

Ting Wua The 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, ChinaCorrespondence[email protected]
View further author information

Jun Zhanga The 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, ChinaView further author information

Hui-Rong Panb Vaccine R&D Department, Xiamen Innovax Biotech Company, Xiamen, Fujian, ChinaCorrespondence[email protected]
View further author information

Chang-Gui Lic National Institute for Food and Drug Control, Division of Respiratory Virus Vaccines, Beijing, ChinaCorrespondence[email protected]
View further author information

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Figures & data

Table 1. Baseline characteristics of participants in the three vaccine lot groups.

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Figure 1. Study flow chart. PPS: per-protocol set.

Table 2. Immuno-response at month 7 among the three lot groups (PPS for immunogenicity).

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Table 3. Equivalence analysis of GMC at month 7 (PPS for immunogenicity).

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Table 4. Immuno-response at month 7 and 42 among three lots groups in participants who were seropositive at baseline^*.

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Figure 2. Reverse cumulative curves for IgG and neutralizing antibody levels of the three lot groups (per-protocol set) at month 7. Panel A: HPV-16 IgG antibody; Panel B: HPV-18 IgG antibody; Panel C: HPV-16 neutralizing antibody; Panel D: HPV-18 neutralizing antibody.

Table 5. Incidence of adverse events (safety analysis).

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Lot-to-lot consistency study of an Escherichia coli-produced bivalent human papillomavirus vaccine in adult women: a randomized trial

Table 1. Baseline characteristics of participants in the three vaccine lot groups.

Table 2. Immuno-response at month 7 among the three lot groups (PPS for immunogenicity).

Table 3. Equivalence analysis of GMC at month 7 (PPS for immunogenicity).

Table 4. Immuno-response at month 7 and 42 among three lots groups in participants who were seropositive at baseline^*.

Table 5. Incidence of adverse events (safety analysis).

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Lot-to-lot consistency study of an Escherichia coli-produced bivalent human papillomavirus vaccine in adult women: a randomized trial

Figures & data

Table 1. Baseline characteristics of participants in the three vaccine lot groups.

Table 2. Immuno-response at month 7 among the three lot groups (PPS for immunogenicity).

Table 3. Equivalence analysis of GMC at month 7 (PPS for immunogenicity).

Table 4. Immuno-response at month 7 and 42 among three lots groups in participants who were seropositive at baseline*.

Table 5. Incidence of adverse events (safety analysis).

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Table 4. Immuno-response at month 7 and 42 among three lots groups in participants who were seropositive at baseline^*.