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

Conditions

Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection

Keywords

Human Papillomavirus 16, Human Papillomavirus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia

Brief summary

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.

Chen Q, Quan J, Zhu K, Lan L, Lu J, Zhu L, Zhang B, Zhong G, Bi Z, Huang S, Su Y, Wei L, Qiao Y, Zhang J, Wu T, Xia N.

2026-01-14

10.1038/s41467-026-68379-3

Immunopersistence of one or two doses of an Escherichia coli produced bivalent HPV vaccine.

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.

2025-12-17

10.1038/s41541-025-01335-2

Long-term efficacy and immunopersistence of an Escherichia coli-produced HPV-16/18 bivalent vaccine: an observational extension study following a randomised, double-blind Phase III clinical trial cohort.

Zhao F, Chen Q, Zhao C, Nie L, Hu S, Yin J, Qiu L, Bi Z, Quan J, Li Y, Li M, Zhang X, Pan Q, Li C, Ke L, Liu X, Zheng F, Dai C, Wang Z, Kuang X, Jia X, Su Y, Huang S, Zhang Q, Huang W, Wei L, Zhang J, Wu T, Qiao Y, Xia N.

2025-08-21

10.1016/j.lanwpc.2025.101668

Long-term protective efficacy of the Escherichia coli-produced HPV-16/18 bivalent human papillomavirus vaccine in women vaccinated at 18-45 years: A 9-year follow-up study.

Jia X, Hu S, Kuang X, Qiao Y.

2025-01-10

10.1016/j.imj.2025.100164

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.

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.

2022-08-2657 citations

10.1016/s1473-3099(22)00435-2

Long-Term immunopersistence and safety of the Escherichia coli -produced HPV-16/18 bivalent vaccine in Chinese adolescent girls

Xingmei Yao, Wengang He, Xiànghóng Wú, Jianxiang Gu, Jing Zhang et al. (13 authors)

Human Vaccines & Immunotherapeutics2022-04-135 citations

10.1080/21645515.2022.2061248

Interventions

BIOLOGICALHPV Vaccine

3 doses at month 0,1 and 6

BIOLOGICALHEV vaccine

3 doses at month 0,1 and 6

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)	expected 2-3 years
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

Secondary

Measure	Time frame
Number of Subjects Reporting Unsolicited Adverse Events	Month 7
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 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
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 Reporting Solicited Local and General Symptoms	Within 7 days after each vaccination

Other

Measure	Time frame	Description
Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types	expected 5-6 years	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).

Countries

China

Outcome results

None listed