Overview

This trial is active, not recruiting.

Conditions cervical intraepithelial neoplasia, cervical cancer, vaginal intraepithelial neoplasia, vulvar intraepithelial neoplasia, persistent infection
Treatments hpv vaccine, hev vaccine
Phase phase 3
Sponsor Xiamen University
Collaborator Xiamen Innovax Biotech Co., Ltd
Start date November 2012
End date September 2016
Trial size 6000 participants
Trial identifier NCT01735006, HPV-PRO-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
hpv vaccine
3 doses at month 0,1 and 6
(Placebo Comparator)
commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
hev vaccine Hecolin
3 doses at month 0,1 and 6

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
time frame: expected 5-6 years
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)
time frame: expected 2-3 years

Secondary Outcomes

Measure
Number of Subjects Reporting Solicited Local and General Symptoms
time frame: Within 7 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
time frame: Month 7
Number of Subjects Reporting Serious Adverse Events (SAEs)
time frame: expected 5-6 years
number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18
time frame: 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
time frame: expected 5-6 years
number of subjects with incidence infection associated with HPV-16 and/or HPV-18
time frame: expected 2-3 years
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7
time frame: month 7

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

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
Principal investigator Youlin Qiao, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Xiamen University.