Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

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.

Sex

Female

Minimum age

18 Years

Maximum age

45 Years

Inclusion Criteria:

1. Female subjects between, and including, 18 and 45 years of age at the first vaccination;
2. Healthy subjects as established by medical history and history-oriented clinical examination;
3. Be able to understand and comply with the request of the protocol;
4. Without acute cervicitis;
5. Not pregnant;
6. Have intact cervix.

Exclusion Criteria:

1. Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
2. Are using immunosuppressants;
3. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
5. Fever;
6. Concurrently participating another clinical trial;
7. Has received vaccines against HPV 16/18 ;
8. Immunodeficient;
9. History of allergic disease;
10. Serious medical disorders;
11. Blood coagulation disorders;
12. Epilepsy;
13. Unable to comply with protocol due to the mental illness;
14. Visible Condyloma;
15. Pregnant or breast-feeding women;
16. vergins;
17. Have more than 4 sexual partners.

• DERIVEDLiao 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. PMID 41407728
• DERIVEDChen Q, Yao X, Quan J, Jia X, Li Y, Zhu K, Hu X, Huang X, Zhong G, Qiu L, Bi Z, Liao M, Chen L, Kuang X, Wang Z, Hu S, Zhuang C, Huang S, Wei L, Chen W, Su Y, Zhao F, Wu T, Qiao Y, Zhang J, Xia N. The variations in the natural history of high-risk human papillomavirus infections in Chinese healthy women aged 27-45 years compared with 18-26 years: A prospective cohort study. Int J Cancer. 2025 Mar 1;156(5):1043-1054. doi: 10.1002/ijc.35290. Epub 2024 Dec 13. PMID 39670565
• DERIVEDZhao 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. PMID 36037823