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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Provincial Centre for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group; 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) .	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.
Active Comparator: Gardasil®9 group; Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .	Biological: Gardasil®9; Three doses administered intramuscularly at 0, 45 day and 6 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xiamen University
• Collaborators: Xiamen Innovax Biotech Co., Ltd; Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
• Investigators: Principal Investigator: Feng-cai Zhu, master, Jiangsu Provincial Centre for Disease Control and Prevention; Study Chair: Jun Zhang, master, Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: immunogenicity; human papillomavirus vaccine
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: HPV-PRO-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No