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

  • STATUS
    Recruiting
  • End date
    Sep 15, 2029
  • participants needed
    8000
  • sponsor
    Shanghai Bovax Biotechnology Co., Ltd.
Updated on 13 March 2022
cancer
primary cancer
human papillomavirus
hpv vaccine
recombinant vaccine
gardasil
human papilloma virus vaccine
intrauterine device (iud)
lab tests
cancer of the cervix
Accepts healthy volunteers

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 .

Details
Condition Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN3, VaIN1, VaIN2, VaIN3, Genital Wart, VIN 1, VIN 2, VIN 3, AIS
Treatment 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha), GARDASIL®
Clinical Study IdentifierNCT04422366
SponsorShanghai Bovax Biotechnology Co., Ltd.
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
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
Previous positive history of HPV
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
Received total hysterectomy or pelvic radiotherapy
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.)
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
the subject is in the menstrual period
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
Second and third doses of vaccine were excluded criteria
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
Second and third doses of vaccine were delayed criteria
urticaria, etc.)
Vaccination may be postponed if
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)
other circumstances that can be postponed as judged by the researcher
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)
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
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
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
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