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

Phase 3

Completed

• Conditions: Cervical Cancer; Condylomata Acuminata
• Interventions: Biological: Gardasil®9; Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

• Registration Number: NCT04782895
• Lead Sponsor: Xiamen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Study Start: 2021-03-14
• Primary Completion: 2022-05-30
• Study Completion: 2022-07-25
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 488

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gardasil®9 group	Gardasil®9	Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .
Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group	Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)	Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .

Primary Outcome Measures

Name	Time	Method
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level	7 months after the first dose	Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7

Secondary Outcome Measures

Name	Time	Method
safety2:Adverse events/reactions occurred within 30 days after each vaccination.	Within 30 days (Day 0-30) after any vaccination	Adverse events/reactions occurred within 30 days after each vaccination.
safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.	Up to 8 month	Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.
safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.	Up to 8 month	Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.
safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.	During the 7-day period following each vaccination	Local and systematic adverse events/reactions occurred within 7 days after each vaccination.

Trial Locations

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention; 🇨🇳 Nanjing, Jiangsu, China