Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Phase 3Active Not RecruitingNCT04537156

Xiamen University9,327 enrolled

Overview

This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

9,327

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer Condylomata Acuminata

Interventions

Nonavalent HPV vaccineBIOLOGICAL

Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Bivalent HPV vaccineBIOLOGICAL

Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female aged between 18 and 45 years at the first vaccination; 2. Be able to understand and comply with the request of the protocol(e.g. biological specimen collection, diary card entry and attend regular follow-up), and sign written informed consent; 3. Women who agree to use effective contraception within 8 months after the first vaccination, or women who have undergone tubal ligation, benign subtotal hysterectomy, benign ovarian tumor removal, or postmenopausal women; 4. The number of sexual partners so far less than four; 5. Have intact cervix and have no history of physical or surgical treatment; 6. No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.); 7. No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN), and no abnormality in gynecological examination; 8. Sexual intercourse has occurred. Exclusion Criteria: 1. Participants with acute cervicitis and acute lower genital tract infection, or with obvious condyloma; 2. Participants during menstruation, or have vaginal medication, sexual behavior (including anal, vaginal or external genital contact, regardless of the sex of parterner) within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection. 3. Axillary temperature \> 37.0℃; 4. Participants who have positive urine pregnancy test, or are pregnant or breastfeeding; 5. Have used other investigational or unregistered products (drugs or vaccines) within 30 days before receiving the research vaccine or have participated in another clinical research in the past two years, or plan to use other research or unregistered products or participate in other research during the research period; 6. Long-term use (more than 14 continuous days) of immunosuppressors and other Immunoregulatory agents or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) 6 months prior to vaccination. 7. Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them during the study. 8. Administration of inactivated vaccine within 14 days before vaccination or live vaccine within 21 days; 9. Fever (Axillary temperature \>38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents (Anti-flu agents include but are not limited to Tamiflu, Tamiflu, Symmetrel and Flumadine) 5 days prior to vaccination. 10. Have received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously; 11. 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 autoimmune diseases that investigators believe may influence the immune response). 12. History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccines, or allergy to any of the components of investigational vaccine. 13. Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids; 14. Suffered from a serious medical illness; 15. Self-report past coagulation disorders or abnormal coagulation function; 16. Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that did not require treatment in the past 3 years; 17. According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the clinical trial.

Locations (2)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Sichuan Provincial Centre for Disease Control and Prevention

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Non-inferiority of anti-HPV 16 and 18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) in the PPS-I set

Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the third dose to determine whether nine-valent HPV vaccine is non-inferior to the control bivalent HPV vaccine

Time frame: Specific neutralizing antibodies at 7 months after first dose

Persistent infection of HPV31, 33, 45, 52 and 58 (over 12 months) (Combined analysis of the 5 types) in the mITT-PI set

To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine

Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose

Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58 (Combined analysis of the 5 types) in the mITT-E when the first two endpoints are satisfied

To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine

Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose

Secondary Outcomes

Efficacy1: Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)

To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine

Time frame: Cumulative incidence of this endpoint events in 78 months after the first dose

Efficacy2: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type)

To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine

Data from ClinicalTrials.gov

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