An Open-Label, Single-Center Phase I Clinical Trial to Estimate Safety of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Unsolicited adverse events
研究概览
简要总结
This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
详细描述
The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the participants would be actively monitored for adverse reactions/events for 1 month after each injection. SAE during the trial were followed up. And blood, liver and kidney function changes will be monitored before and 2 days after the first and third vaccination. Serum samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity as exploratory analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health people aged between 18 and 45 years.
- •Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- •Able to comply with the requests of the study.
- •Written informed consent obtained from the participants.
- •Axillary temperature not higher than 37.0°C
- •Men, or non-pregnant women verified by a urine pregnancy test.
排除标准
- •Pregnant or breastfeeding or plan to be pregnant within 7 months.
- •Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
- •Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
- •Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine or plan to use within 7 months.
- •Administration of any attenuated live vaccines within 21 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.
- •Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
- •Having the plan to participate another clinical trial during the study period.
- •Received another HPV vaccine.
- •Immunodeficiency , primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
- •History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
- •Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.
- •Having serious disease of internal medicine, such as hypertension(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al.
- •Diagnosed coagulant function abnormality or blood coagulation disorder. 14) The results of blood routine test and blood biochemical test were abnormal. The grade was 2 or above.
- •Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.
- •Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.
- •Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.
结局指标
主要结局
Unsolicited adverse events
时间窗: Within 30 days (Day 0-29) after any vaccination
Unsolicited adverse reactions occurred within 30 days after each vaccination;
Solicited local adverse reactions
时间窗: During the 7-day (Day 0-6) period following each vaccination
Solicited local adverse reactions occurred within 7 days after each vaccination;
Solicited systematic adverse reactions
时间窗: During the 7-day (Day 0-6) period following each vaccination
Solicited systematic adverse reactions occurred within 7 days after each vaccination;
Serious adverse events
时间窗: throughout the study period, an average of 7 months
Serious adverse events occurred throughout the study;
次要结局
- Clinically Relevant Abnormalities in Hematological Parameters(Before and the second day after the first and third vaccination)
- Clinically Relevant Abnormalities in Blood Biochemistry(Before and the second day after the first and third vaccination)
研究者
Jun Zhang
Professor
Xiamen University