Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

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Brief Title

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Official Title

A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

Brief Summary

      The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV
      recombinant vaccine in Chinese healthy females 20 to 45 years of age.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.

Secondary Outcome

 The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

Condition

Cervical Cancer

Intervention

4-valent HPV Vaccine

Study Arms / Comparison Groups

 4-valent HPV Vaccine
Description:  Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)

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

1680

Start Date

May 28, 2020

Completion Date

December 28, 2021

Primary Completion Date

December 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Chinese women aged 20-45 who can provide legal identification;

          2. The subject agreed to participate in the study, and voluntarily signs the informed
             consent;

          3. Subjects are able to understand the study procedures and participate in follow-up
             according to the study requirements;

          4. When the subjects were enrolled, the urine pregnancy test was negative, they were not
             in the lactation period and had no family planning within 7 months after enrollment.2
             weeks before included in the study, effective contraceptive measures has been adopted
             and agreed to in the first seven months after the study (vaccinations after 1 months
             ago) continue to adopt effective contraceptive measures (effective contraceptive
             measures including the pill or condoms, etc );

        Exclusion Criteria:

          1. Have been vaccinated with commercially available HPV vaccine in the past or planned to
             be vaccinated with commercially available HPV vaccine during the study period;Or have
             participated in a clinical trial of the HPV vaccine;

          2. Has a history of cervical diseases, such as cervical screening showing abnormal
             results including CIN or a history of hysterectomy (vaginal or total abdominal
             hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as
             vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,
             vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history
             (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma
             inguinal);

          3. A history of severe allergies requiring medical intervention, such as anaphylactic
             shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local
             allergic necrosis reaction (Arthus reaction), etc;

          4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to
             vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g.,
             acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);

          5. Subjects received inactivated or recombinant vaccines within 14 days prior to study
             enrollment, or attenuated live vaccines within 28 days prior to study enrollment;

          6. Subjects present with immune impairment or have been diagnosed with congenital or
             acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus
             erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA),
             inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive
             therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g.,
             prednisone or similar drugs);

          7. Has been diagnosed with a severe congenital malformation or chronic disease such as
             Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may
             interfere with the conduct or completion of the study;

          8. Subject receives any immunoglobulin or blood product within 3 months prior to the
             first dose of vaccination;

          9. Participating in other (drug or vaccine) clinical trials prior to enrollment or
             planning to participate during the study;

         10. Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis
             and/or HIV infection;

         11. A history or family history of convulsions, epilepsy, encephalopathy and mental
             illness;

         12. Have contraindications to intramuscular injection, such as having been diagnosed with
             thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;

         13. Absence of a spleen, functional absence of a spleen, and absence or removal of a
             spleen in any case;

         14. Body temperature ≥37.3℃ (underarm body temperature);

         15. Subjects may be unable to comply with the study procedure, comply with the agreement,
             or plan to permanently relocate from the region prior to completion of the study, or
             may be permanently absent from the region during the scheduled visit;

         16. In the opinion of the investigators, the subjects had any other factors that made them
             unsuitable to participate in the clinical trial.
      

Gender

Female

Ages

20 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +8613631315751, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04425291

Organization ID

4-HPV-3001


Responsible Party

Sponsor

Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Collaborators

 Chongqing Bovax Biopharmaceutical Co., Ltd.

Study Sponsor

, , 


Verification Date

June 2020