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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV vaccine | Experimental | This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant |
|
| HEV vaccine | Placebo Comparator | commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine | Biological | 3 doses at month 0,1 and 6 |
| |
| HEV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection | expected 5-6 years | |
| Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) | expected 2-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Local and General Symptoms | Within 7 days after each vaccination | |
| Number of Subjects Reporting Unsolicited Adverse Events | Month 7 | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types | Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR). | expected 5-6 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, Master | Xiamen University | Study Chair |
| Youlin Qiao, Ph.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Ting Wu, Ph. D | Xiamen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41407728 | Derived | Liao M, Quan J, Zhu K, Hu X, Shen S, Xu J, Nie C, Xu W, Jiang H, Wu X, Zhong Y, Peng Y, Cai S, Chen J, Zhang C, Lin B, Su Y, Huang S, Chen Q, Wu T, Zhang J, Xia N. Immunopersistence of one or two doses of an Escherichia coli produced bivalent HPV vaccine. NPJ Vaccines. 2025 Dec 17;11(1):16. doi: 10.1038/s41541-025-01335-2. | |
| 36037823 |
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| Biological |
3 doses at month 0,1 and 6 |
|
|
| Number of Subjects Reporting Serious Adverse Events (SAEs) |
| expected 5-6 years |
| number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 | expected 5-6 years |
| number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection | expected 5-6 years |
| number of subjects with incidence infection associated with HPV-16 and/or HPV-18 | expected 2-3 years |
| Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 | month 7 |
| Zhao FH, Wu T, Hu YM, Wei LH, Li MQ, Huang WJ, Chen W, Huang SJ, Pan QJ, Zhang X, Hong Y, Zhao C, Li Q, Chu K, Jiang YF, Li MZ, Tang J, Li CH, Guo DP, Ke LD, Wu X, Yao XM, Nie JH, Lin BZ, Zhao YQ, Guo M, Zhao J, Zheng FZ, Xu XQ, Su YY, Zhang QF, Sun G, Zhu FC, Li SW, Li YM, Pan HR, Zhang J, Qiao YL, Xia NS. 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. Lancet Infect Dis. 2022 Dec;22(12):1756-1768. doi: 10.1016/S1473-3099(22)00435-2. Epub 2022 Aug 26. |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| D000088562 | Persistent Infection |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| C577000 | hecolin |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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