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

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Brief Title

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

Official Title

A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 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

      This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the
      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 .
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3

Secondary Outcome

 The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3

Condition

Cervical Cancer

Intervention

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

Study Arms / Comparison Groups

 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52
Description:  Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) 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

9600

Start Date

April 28, 2020

Completion Date

September 15, 2029

Primary Completion Date

September 15, 2027

Eligibility Criteria

        Inclusion Criteria:

        (If the "*" option is not met during screening, the visit can be rescheduled)

          -  Chinese women aged 20-45 who can provide legal identification and have a sexual life
             history;

          -  The subject fully understands the study procedures, understands the risks and benefits
             associated with participating in the study, and voluntarily signs the informed
             consent;

          -  Subjects are able to read, understand and fill in application forms such as diary
             CARDS and contact CARDS, and participate in follow-up according to the study
             requirements;

          -  Subjects have not been screened for cervical cancer, or have been screened for
             cervical cancer but the results are normal;

          -  *0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal
             cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to
             refrain from sexual intercourse (including anal, vaginal, or genital/genital contact
             of the same or opposite sex) for 48 hours prior to any visit that includes
             gynecological sample collection, and to refrain from vaginal flushing, vaginal
             cleansing, or use of vaginal medications or preparations for 72 hours;

          -  When the subjects were enrolled, the urine pregnancy test was negative (sensitivity
             was 25mIU/ml cox-hcg), they were not in the lactation period and had no family
             planning within 7 months after enrollment (1 month before whole-course inoculation).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 include: the pill, injection or embedded contraception, slow-release local
             birth control pills, hormone patch, the intrauterine device (IUD), sterilization,
             abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and
             emergency contraception is unacceptable contraception;

          -  *body temperature <37.3℃ (underarm body temperature)

        Exclusion Criteria:

        First dose exclusion criteria(If the "*" option is met during screening, the visit can be
        rescheduled)

          -  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 and have received a
             vaccine/placebo vaccination;

          -  Previous positive history of HPV;

          -  Has a history of abnormal cervical cytology, including squamous intraepithelial
             lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except
             the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H),
             atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia
             (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;

          -  Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia,
             vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and
             anal cancer, etc.);

          -  Received total hysterectomy or pelvic radiotherapy;

          -  Cervical insufficiency or abnormal cervical structure (judged by the results of
             routine gynecological examination);

          -  Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic
             granuloma, granuloma inguinal) or have obvious condyloma;

          -  A history of seizures, convulsions or convulsions, or a family history of mental
             illness;

          -  Have participated in other gynecology-related clinical trials within 6 months, and
             have used or plan to use other investigational or unregistered products (drugs or
             vaccines) other than the vaccine in this study within 3 months;

          -  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.A history of severe adverse
             reactions to previous vaccinations or a history of severe allergies to any of the
             components of the vaccine under study (histidine, polysorbate, aluminum phosphate,
             sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection)
             (such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe
             urticaria, etc.);

          -  Subject receives any immunoglobulin or blood product within 3 months prior to the
             first dose of vaccination, or plans to receive such product within the next 7 months
             (1 month prior to the full course of vaccination);

          -  Subjects present/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;

          -  Immunosuppressant therapy within 1 month before the first dose of vaccination, such as
             long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks,
             such as prednisone or similar drugs;Topical administration (such as ointment, eye
             drops, inhalant or nasal spray) not exceeding the recommended dosage in the directions
             or showing any signs of systemic exposure) or planning to receive such treatment
             within the next 7 months (1 month before the full course of inoculation);

          -  Absence of spleen or functional absence of spleen, and absence of spleen or
             splenectomy in any case;

          -  Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant
             tumor with complications;

          -  Patients with thrombocytopenia or any coagulation disorders that may be
             contraindications to intramuscular injection;

          -  * subjects received inactivated or recombinant vaccines within 14 days prior to study
             enrollment, or attenuated live vaccines within 28 days prior to study enrollment;

          -  * 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.);

          -  * the first dose of vaccine was in pregnancy at the time of vaccination, or the end of
             pregnancy had not exceeded 6 weeks;

          -  * after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3℃)
             before the first day of vaccination (within 24 hours before vaccination);

          -  * the subject is in the menstrual period;

          -  * severe acute vaginitis and suppurative cervicitis found by naked eye during
             gynecological examination (purulent secretion visible by naked eye);

          -  Blood pressure on physical examination before the first dose of vaccination was higher
             than normal or increased (systolic blood pressure ≥140mmHg and/or diastolic blood
             pressure ≥90mmHg);

          -  Gynecological examination before the first dose of vaccination suspected genital
             warts, or on the basis of clinical symptoms and signs suspected vulva, vagina or
             cervical precancerous lesions and the possibility of cancer;

          -  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;

          -  In the opinion of the investigators, the subjects had any other factors that made them
             unsuitable to participate in the clinical trial, so that continued participation in
             the study could not guarantee the maximum benefit of the subjects.

        Second and third doses of vaccine were excluded criteria

          -  new discoveries or new occurrences that meet the first dose exclusion criteria (except
             for articles 2, 3, 4, 21);

          -  other serious adverse events: the investigator decides whether to terminate the
             experimental vaccination according to its treatment needs;

          -  the investigator assays for any other reasons that may be considered necessary to
             terminate the trial vaccination.

        Second and third doses of vaccine were delayed criteria

        Vaccination may be postponed if:

          -  fever (underarm body temperature ≥37.3℃);

          -  before inoculation (on the day of inoculation), the urine pregnancy test was positive
             (sensitivity was 25mIU/ml n-hcg);

          -  acute illness or acute attack of a chronic disease or use of antipyretic, analgesic
             and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine,
             cetirizine, etc.) within 3 days before vaccination;

          -  insufficient interval between other vaccines (inactivated or recombinant vaccines
             received within 14 days prior to vaccination, or any live attenuated vaccine received
             within 28 days);

          -  any immunoglobulin or blood products received during vaccination should be
             administered at least 3 months after the vaccination;

          -  other circumstances that can be postponed as judged by the researcher.
      

Gender

Female

Ages

20 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, +8615177771508, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04422366

Organization ID

9-HPV-3001


Responsible Party

Sponsor

Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.


Study Sponsor

, , 


Verification Date

May 2020