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

Cervical Intraepithelial Neoplasia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Intraepithelial Neoplasia

Cervical Cancer

Vaginal Intraepithelial Neoplasia

Vulvar Intraepithelial Neoplasia

Persistent Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:HPV Vaccine3 doses at month 0,1 and 6

Biological:HEV vaccine3 doses at month 0,1 and 6

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HPV vaccineThis dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant

HEV vaccinecommercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant

Study Status

Active, not recruiting

Start Date: November 22, 2012

Completed Date: February 28, 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection

Secondary Outcome: Number of Subjects Reporting Solicited Local and General Symptoms

Study sponsors, principal investigator, and references

Principal Investigator: Jun Zhang, Master

Lead Sponsor: Xiamen University

Collaborator: Xiamen Innovax Biotech Co., Ltd

More information:https://clinicaltrials.gov/show/NCT01735006

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