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

Phase 3

Completed

• Conditions: Vaginal Intraepithelial Neoplasia; Cervical Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection; Cervical Cancer
• Interventions: Biological: HEV vaccine; Biological: HPV Vaccine

• Registration Number: NCT01735006
• Lead Sponsor: Xiamen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-18
• Study Start: 2012-11-22
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-28
• Primary Completion: 2019-08-01
• Study Completion: 2019-10-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7372

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEV vaccine	HEV vaccine	commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
HPV vaccine	HPV Vaccine	This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Unsolicited Adverse Events	Month 7
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 Reporting Solicited Local and General Symptoms	Within 7 days after each vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)	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

Trial Locations

Locations (1)

Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China