A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Reporting Solicited Local Symptoms
研究概览
简要总结
A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females, 9 to 45 years old (inclusive).
- •9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
- •Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
- •18 to 45 years old participants: able to prove their legal identities.
- •18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
- •Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period.
排除标准
- •History of cervical cancer or genital warts.
- •History HPV vaccination or history of participation in HPV vaccine trial.
- •History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
- •Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
- •History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination.
- •Medical history of epilepsy, convulsions, seizures , or family history of mental illness.
- •Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination.
- •History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy.
- •Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy
- •Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder
- •Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days.
- •Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination.
- •Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination.
- •Fever before vaccine administration with axillary temperature higher than 37.0°C.
- •Currently breastfeeding, and being pregnant including pregnancy test positive.
- •History of hypertension: Participants of 13 to 45 years of age have their respective systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg; or participants of 9 to 12 years of age demonstrate their respective systolic blood pressure higher than 120 mmHg and/or diastolic blood pressure higher than 80 mmHg.
- •Exhibits of abnormal lab test parameters.
- •Any other factors which might affect any individual to be enrolled in the study according to the investigator's judgment.
研究组 & 干预措施
HPV vaccine
Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
干预措施: HPV Vaccine (Biological)
Placebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Reporting Solicited Local Symptoms
时间窗: During a 8-day period (Day 0-7) following each vaccination
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Percentage of Subjects Reporting Solicited General Symptoms
时间窗: During a 8-day period (Day 0-7) following each vaccination
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
时间窗: Within 31 days (Day 0-30) after any vaccination
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Percentage of Subjects Reporting Serious Adverse Events (SAE)
时间窗: Throughout the study period (up to Month 12)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
次要结局
- Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(30 days after the third dose (Month 7))
- Geometric Mean Titers (GMT) of HPV serotype-specific antibody(30 days after the third dose (Month 7))