A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

NCT ID: NCT05262010

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 13500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-04
• Study Completion Date: 2028-06-30

Brief Summary

A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Conditions

HPV InfectioN; HPV-Related Carcinoma

Study Design

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

Study Groups

experiment group

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

Group Type: EXPERIMENTAL

11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)

Intervention Type: BIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

placebo

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Interventions

11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

Intervention Type: BIOLOGICAL

placebo

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• non-gynecological related

1. *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;

2. *Axillary body temperature <37.3℃ on the day of enrollment;

3. The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;

4. Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;

5. No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;

6. The subject has a negative urine pregnancy test on the day before vaccination.

• Gynecology related

7. *Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.

8. *Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.

Exclusion Criteria

(Visits may be rescheduled if the criteria described in the "*" option are met at screening)

• Non-gynecological related

1. * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;

2. *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;

3. *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;

4. *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);

5. History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);

6. Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;

7. 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;

8. Previous splenectomy or impaired spleen function;

9. Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;

10. Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;

11. Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;

12. Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;

13. The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).

• Gynecology related

14. *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;

15. *The subject is in the menstrual period;

16. *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;

17. Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);

18. Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);

19. Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.

If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.

• Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chengdu Institute of Biological Products Co.,Ltd.

INDUSTRY

Sponsor Role: collaborator

Simoon Record Pharma Information Consulting Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Beijing Kantorico Statistical Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Hunan Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Sichuan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: collaborator

National Vaccine and Serum Institute, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hechi Yizhou District Center for Disease Control and Prevention

Hechi, Guangxi, China

Site Status: NOT_YET_RECRUITING

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, China

Site Status: NOT_YET_RECRUITING

Lianyuan Center for Disease Control and Prevention

Lianyuan, Hunan, China

Site Status: RECRUITING

Qiyang Center for Disease Control and Prevention

Wuxi, Hunan, China

Site Status: RECRUITING

Yongji Center for Disease Control and Prevention

Yongji, Shanxi, China

Site Status: NOT_YET_RECRUITING

Yuanqu Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Site Status: NOT_YET_RECRUITING

Mianyang Youxian District Center for Disease Control and Prevention

Mianyang, Sichuan, China

Site Status: NOT_YET_RECRUITING

Neijiang Shizhong District Center for Disease Control and Prevention

Neijiang, Sichuan, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Zhaojun Mo

Role: CONTACT

mozhj@126.com

（+86）15177771508

Facility Contacts

ming han

Role: primary

（+86）18934923075

Jian biao Li

Role: primary

（+86）18978463935

Hui Deng

Role: primary

（+86）13789255955

Ling Tan

Role: primary

（+86）18974676669

Yong Yan

Role: primary

（+86）15835919188

Xiaohong Cui

Role: primary

（+86）13903488150

gang Xie

Role: primary

（+86）13778031535

Ling zhong

Role: primary

（+86）18981435233

Other Identifiers

GXIRB2021-0029-1

Identifier Type: -

Identifier Source: org_study_id