Evaluating a 9-valent HPV vaccine in young Chinese females

Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

This study is testing a new 9-valent HPV vaccine in young Chinese girls and women aged 9 to 19 to see how well it works and if it's safe compared to older women.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 9 Years to 45 Years
• Sex: Female
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. (industry)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT04895020 on ClinicalTrials.gov

What this trial studies

This phase 3 study assesses the immunogenicity and safety of a 9-valent HPV recombinant vaccine in Chinese females aged 9 to 19 years, comparing their immune response to that of older participants aged 20 to 45 years. The study will involve administering a three-dose schedule of the vaccine and monitoring both the immune response and safety profile. Participants will be required to provide informed consent, and those who are minors will need consent from a legal guardian. Regular follow-ups will be conducted to ensure adherence to study protocols.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy Chinese females aged 9 to 19 years who meet the inclusion criteria.

Not a fit: Patients outside the age range of 9 to 19 years or those with existing health conditions that may affect vaccine response may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance HPV vaccination strategies and improve protection against HPV-related cancers in young females.

How similar studies have performed: Other studies have shown positive outcomes with similar HPV vaccine approaches, indicating a promising avenue for immunization.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria for the first stage:

1. Healthy Chinese females aged 9 to 45 years; Provide legal identification;
2. The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
3. Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
4. Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
5. No fever symptoms on the day of enrollment (aged\> 14 years old, axillary temperature\<37.3°C; aged ≤ 14 years old, axillary temperature\<37.5°C );

   Inclusion Criteria for the second stage:
6. Received all 3 doses of trial vaccination;
7. Subjects aged 9 to 19 years at the first stage.

Exclusion Criteria:

1. Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
2. History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, AIS, and cervical cancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), or history of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
3. Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
4. Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from day 0 to month 7 after the last dose;
5. Had chronic diseases or congenital malformations, which might interfere with the process and completion of this study, such as Down Syndrome, heart diseases, liver diseases, chronic diabetes complications, and malignant tumor;
6. Enrolling or plan to enroll in other clinical trials (drug or vaccine);
7. Had infectious diseases such as TB, viral hepatitis, and/or HIV infection;
8. Had convulsions, epilepsy, encephalopathy, and mental illness or family history;
9. With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
10. Asplenic, functionally asplenic, or splenectomy caused by any condition;
11. Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
12. Receipt of inactivated or recombinant vaccines within 14 days, live vaccines within 28 days;
13. Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period;
14. Had fever symptoms within 24 hours on the first day (aged\> 14 years old, axillary temperature ≥ 37.3°C; aged ≤ 14 years old, axillary temperature ≥37.5°C );
15. Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP\>120mmHg and/or diastolic BP\>80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
16. Plan to permanently relocate from the area before the end of the study or leave the local area for a long time during the study visit (affecting the scheduled visit time);
17. According to the investigator's judgment, the subject has any condition may interfere with process of evaluation or participating in this study cannot guarantee the object's maximum benefit.

Where this trial is running

Hangzhou

• Huakun Lv — Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Huakun Lv

Conditions: HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3, VaIN1