Clinical trial NCT01735006: Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine
Official title: A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2012-11-28
Enrollment: 7372
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection
timeFrame: expected 5-6 years
measure: Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)
timeFrame: expected 2-3 years
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local and General Symptoms
timeFrame: Within 7 days after each vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: Month 7
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: expected 5-6 years
measure: number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18
timeFrame: expected 5-6 years
measure: number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection
timeFrame: expected 5-6 years
measure: number of subjects with incidence infection associated with HPV-16 and/or HPV-18
timeFrame: expected 2-3 years
measure: Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7
timeFrame: month 7
Other outcomes:
measure: Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types
timeFrame: expected 5-6 years
Locations:
city: Beijing
country: China
facility: Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Xiamen University
name: Jun Zhang, Master
role: STUDY_CHAIR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Youlin Qiao, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiamen University
name: Ting Wu, Ph. D
role: STUDY_DIRECTOR
References:
citation: 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.