NCT05262010招募中3 期
A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
National Vaccine and Serum Institute, China8 个研究点 分布在 1 个国家目标入组 13,500 人开始时间: 2022年6月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 13,500
- 试验地点
- 8
- 主要终点
- Person-years incidence of CIN2+ associated with HPV6/11/16/18.
研究概览
简要总结
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- non-gynecological related
- •*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- •*Axillary body temperature <37.3℃ on the day of enrollment;
- •The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- •Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
- •No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
- •The subject has a negative urine pregnancy test on the day before vaccination.
- •- Gynecology related
- •*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
- •*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.
排除标准
- •First dose exclusion criteria:
- •(Visits may be rescheduled if the criteria described in the "*" option are met at screening)
- •- Non-gynecological related
- •* Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
- •*3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- •*Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
- •*3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
- •History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
- •Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
- •1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
- •Previous splenectomy or impaired spleen function;
- •Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
- •Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
- •Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
- •Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
- •The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).
- •- Gynecology related
- •*Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
- •*The subject is in the menstrual period;
- •*Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
- •Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);
- •Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
- •Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.
- •Exclusion criteria for 2nd and 3rd dose vaccination：
- •If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.
- •Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
- •Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
研究组 & 干预措施
experiment group
Experimental
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
干预措施: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) (Biological)
placebo
Placebo Comparator
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo
干预措施: placebo (Biological)
结局指标
主要结局
Person-years incidence of CIN2+ associated with HPV6/11/16/18.
时间窗: 1 month after 3 doses of vaccine
Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68
时间窗: 1 month after 3 doses of vaccine
次要结局
- Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68(After at least 1 dose of vaccine)
- Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.(1 month after 3 doses of vaccine)
- Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6(1 month after 3 doses of vaccine)
- Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58(1 month after 3 doses of vaccine)
- Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).(After at least 1 dose of vaccine)
- Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18(After at least 1 dose of vaccine)
- Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types.(After at least 1 dose of vaccine)
- AE incidence and severity distribution(0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days))
- SAE incidence(During the study，an average of 6 year)
- Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form)(The first dose of vaccination to within 6 months after the full vaccination)
- To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)(7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination)
- To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula)(7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination)
- Number of pregnant(The first dose of vaccination to within 6 months after the full vaccination)
- Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).(1 month after 3 doses of vaccine)
- AE incidence and severity distribution(The first dose of vaccination to within 1 month after the full vaccination)
研究者
研究点 (8)
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