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

NCT ID: NCT04782895

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-14
• Study Completion Date: 2022-07-25

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.

Conditions

Cervical Cancer; Condylomata Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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) .

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Intervention Type: BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Gardasil®9 group

Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .

Group Type: ACTIVE_COMPARATOR

Gardasil®9

Intervention Type: BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Interventions

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.

Intervention Type: BIOLOGICAL

Gardasil®9

Three doses administered intramuscularly at 0, 45 day and 6 month.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang, master

Role: STUDY_CHAIR

Xiamen University

Feng-cai Zhu, master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Centre for Disease Control and Prevention

Locations

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Countries

China

References

Zhu FC, Zhong GH, Huang WJ, Chu K, Zhang L, Bi ZF, Zhu KX, Chen Q, Zheng TQ, Zhang ML, Liu S, Xu JB, Pan HX, Sun G, Zheng FZ, Zhang QF, Yi XM, Zhuang SJ, Huang SJ, Pan HR, Su YY, Wu T, Zhang J, Xia NS. Head-to-head immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil 9 in women aged 18-26 years in China: a randomised blinded clinical trial. Lancet Infect Dis. 2023 Nov;23(11):1313-1322. doi: 10.1016/S1473-3099(23)00275-X. Epub 2023 Jul 17.

Reference Type: DERIVED

PMID: 37475116 (View on PubMed)

Other Identifiers

HPV-PRO-011

Identifier Type: -

Identifier Source: org_study_id