Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

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Brief Title

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Official Title

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

Brief Summary

      This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant
      vaccine in Chinese females aged 9 to 45 years
    

Detailed Description

      This study (protocol 9-HPV-3003) is an immunogenicity and safety study in the subjects (9-19
      years of age) who received the 9-valent HPV recombinant vaccine compared with the subjects
      (20-45 years of age). In this study, we will assess whether the immunogenicity of the
      9-valent HPV vaccine given 3-dose schedule in the subjects (9-19 years of age) in noninferior
      to that in the subjects (20-45 years of age) receiving 3 doses, while assessing the safety of
      this vaccine.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The primary immunogenicity objective

Secondary Outcome

 Number of patients with postive antibodies after the whole schedule vaccination from the former negative subjects

Condition

HPV Infections

Intervention

9-valent HPV vaccine

Study Arms / Comparison Groups

 9-valent HPV vaccine
Description:  9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1200

Start Date

May 28, 2021

Completion Date

May 2026

Primary Completion Date

December 2021

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.
      

Gender

Female

Ages

9 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Person(s) responsible for the overall scientific leadership of Lv, 13588458021, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04895020

Organization ID

9-HPV-3003


Responsible Party

Sponsor

Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Collaborators

 Chongqing Bovax Biopharmaceutical Co., Ltd.

Study Sponsor

Person(s) responsible for the overall scientific leadership of Lv, Study Director, Zhejiang Provincial Center for Disease Control and Prevention


Verification Date

May 2021