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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735006
• Other study ID #: HPV-PRO-003
• Status: Completed
• Phase: Phase 3
• Start date: November 22, 2012
• Est. completion date: October 18, 2019

Study information

• Verified date: February 2020
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7372
• Est. completion date: October 18, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Persistent Infection
• Uterine Cervical Neoplasms
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia

Intervention

Biological:
• HPV Vaccine
3 doses at month 0,1 and 6
• HEV vaccine
3 doses at month 0,1 and 6

Locations

Country	Name	City	State
China	Cancer Institute & Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Xiamen University	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Ministry of Science and Technology of the People´s Republic of China, Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types	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).	expected 5-6 years
Primary	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
Primary	Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)		expected 2-3 years
Secondary	Number of Subjects Reporting Solicited Local and General Symptoms		Within 7 days after each vaccination
Secondary	Number of Subjects Reporting Unsolicited Adverse Events		Month 7
Secondary	Number of Subjects Reporting Serious Adverse Events (SAEs)		expected 5-6 years
Secondary	number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18		expected 5-6 years
Secondary	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
Secondary	number of subjects with incidence infection associated with HPV-16 and/or HPV-18		expected 2-3 years
Secondary	Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7		month 7