Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Shanghai Bovax Biotechnology

Status and phase: Enrolling; Phase 3

Conditions: CIN1; CIN2; HPV Infections; Vaginal Cancer; CIN3; Genital Wart; Cervical Cancer Stage IIa

Treatments: Biological: 3-doses Group among 20-26 years; Biological: 3-doses Group among 9-19 years; Biological: 2-doses Group among 9-14 years

Study type: Interventional

Funder types: Industry

Identifiers

NCT05027776

4-HPV-3002

Details and patient eligibility

About

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Full description

This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits.

This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.

Enrollment: 1,348 estimated patients

Sex: Female

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy Chinese females aged 9 to 26 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. 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;
4. 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 );
5. Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;

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. Enrolling or plan to enroll in other clinical trials (drug or vaccine);
3. History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
4. History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
5. 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.;
6. Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
7. History of epilepsy and convulsions (except fever convulsions in children under 5 years of age);
8. Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy;
9. 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);
10. With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
11. Asplenic, functionally asplenic, or splenectomy caused by any condition;
12. 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 month 0 to month 7；
13. Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period（month 0 to month 7）;
14. 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.);
15. Receipt of inactivated, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days;
16. Subjects with existing mental illness, History of mental illness, or Family History;
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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,348 participants in 3 patient groups

Experimental: 2-doses Group

Experimental group

Description:

Subjects aged 9-14 years, received 2 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 6-month schedule.

Treatment:

Biological: 2-doses Group among 9-14 years

Experimental: 3-doses Group

Experimental group

Description:

Subjects aged 9-19 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.

Treatment:

Biological: 3-doses Group among 9-19 years

Acitve Group

Active Comparator group

Description:

Subjects aged 20-26 years, received 3 doses of q-HPV vaccine, which was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 2，6-month schedule.

Treatment:

Biological: 3-doses Group among 20-26 years