Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

Cervical Cancer Clinical Trial

Official title:

A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782895
• Other study ID #: HPV-PRO-011
• Status: Completed
• Phase: Phase 3
• Start date: March 14, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: June 2023
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: July 25, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

1. Subject is female, between and including 18-26 years of age at the first vaccination;

2. Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;

3. Subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;

4. No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);

5. No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);

Exclusion Criteria:

1. Axillary temperature > 37.0?;

2. Subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;

3. Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;

4. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.

5. Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.

6. Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;

7. Fever (Axillary temperature =38.0?) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days prior to vaccination;

8. Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;

9. Subject has immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).

10. History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.

11. Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;

12. Subject has Serious medical disorders;

13. Self-report coagulation disorders or abnormal coagulation function;

14. Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;

15. Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Related Conditions & MeSH terms

• Cervical Cancer
• Condylomata Acuminata
• Uterine Cervical Neoplasms

Intervention

Biological:
• Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Three doses administered intramuscularly at 0, 45 day and 6 month.
• Gardasil®9
Three doses administered intramuscularly at 0, 45 day and 6 month.

Locations

Country	Name	City	State
China	Jiangsu Provincial Centre for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at months 7(type specific IgG antibody)	7 months after the first dose
Primary	Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level	Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7	7 months after the first dose
Secondary	safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.	Local and systematic adverse events/reactions occurred within 7 days after each vaccination.	During the 7-day period following each vaccination
Secondary	safety2:Adverse events/reactions occurred within 30 days after each vaccination.	Adverse events/reactions occurred within 30 days after each vaccination.	Within 30 days (Day 0-30) after any vaccination
Secondary	safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.	Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.	Up to 8 month
Secondary	safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.	Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.	Up to 8 month