A vaccine for preventing HPV in Chinese women aged 9-45

A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

This study is testing a new HPV vaccine to see if it can help prevent infections and related cancers in Chinese women aged 9 to 45.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13500 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: National Vaccine and Serum Institute, China (Industry-sponsored)
• Drugs / interventions: radiation, prednisone
• Locations: 8 sites (Hechi, Guangxi and 7 other locations)
• Trial ID: NCT05262010 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of an 11-valent recombinant human papillomavirus vaccine in preventing HPV infections and related carcinomas among Chinese women aged 18-45. A total of 13,500 participants are randomly assigned to receive either the vaccine or a placebo in a 1:1 ratio, with three doses administered over six months. The study aims to assess the vaccine's safety and effectiveness across different age groups within the target population.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese women aged 18-45 who have a history of sexual activity and meet specific health criteria.

Not a fit: Patients who have previously received an HPV vaccine or are currently pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of HPV infections and related cancers in the targeted demographic.

How similar studies have performed: Previous studies on HPV vaccines have shown significant success in reducing HPV-related diseases, indicating a promising outlook for this approach.

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:

First dose 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.

Exclusion criteria for 2nd and 3rd dose vaccination：

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

* Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
* Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.

Where this trial is running

Hechi, Guangxi and 7 other locations

• Hechi Yizhou District Center for Disease Control and Prevention — Hechi, Guangxi, China (Not_yet_recruiting)
• Hezhou Center for Disease Control and Prevention — Hezhou, Guangxi, China (Not_yet_recruiting)
• Lianyuan Center for Disease Control and Prevention — Lianyuan, Hunan, China (Recruiting)
• Qiyang Center for Disease Control and Prevention — Wuxi, Hunan, China (Recruiting)
• Yongji Center for Disease Control and Prevention — Yongji, Shanxi, China (Not_yet_recruiting)
• Yuanqu Center for Disease Control and Prevention — Yuncheng, Shanxi, China (Not_yet_recruiting)
• Mianyang Youxian District Center for Disease Control and Prevention — Mianyang, Sichuan, China (Not_yet_recruiting)
• Neijiang Shizhong District Center for Disease Control and Prevention — Neijiang, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Zhaojun Mo

Conditions HPV InfectioN; HPV-Related Carcinoma; HPV Infection HPV vaccine