NCT02603055已完成1 期
A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China
Jiangsu Province Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年7月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of adverse reactions after vaccination
研究概览
简要总结
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine.
This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 16 and 65 years with normal intelligence.
- •Negative in antibody against hepatitis E test.
- •No plan to go out for a long time within 9 months.
- •Able to understand the content of informed consent and willing to sign the informed consent
- •General good health as established by medical history and physical examination.
- •Able and willing to complete all the secluded study process during the whole study follow-up period.
- •No history of hepatitis B, hepatitis C and hepatitis E(Patients diagnosed as hepatitis B, hepatitis C and hepatitis E by town or above)
- •Axillary temperature ≤37.0°C on the day of enrollment
排除标准
- •Woman who is pregnant, breast-feeding or planning to be pregnant during the study period
- •Allergic history of any vaccination or drugs, or allergic to any ingredient of the Hepatitis E vaccine
- •History of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain
- •Autoimmune disease or immunodeficiency
- •Asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years
- •Type I or II diabetes, not including gestational diabetes
- •History of thyroidectomy, or need treatment for thyroid disease in the past 12 months
- •History of serious angioneurotic edema in the past 3 years, or need treatment for it in the past 2 years
- •Severe hypertension, with the blood pressure still more than 150/100 mmHg after drug maintenance treatment
- •Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by the doctor.
- •Patients who are active or not have a definite cure of malignant tumors, or who may recur in the study period.
- •Epilepsy, not including alcohol epilepsy in the first 3 years abstinence or simple epilepsy without the need of treatment in the past 3 years
- •Asplenia or functional asplenia, or asplenia and splenectomy under any circumstances
- •Guillain Barre Syndrome
- •Prior administration of immunodepressant, cytotoxic or corticosteroids (not including corticosteroid therapy for allergic rhinitis and acute non concurrent dermatitis )treatment in last 6 months
- •Prior administration of immune globulin in last 3 months
- •Prior administration of other research medicines in last 1 month
- •Prior administration of attenuated vaccine in last 1 month
- •Prior administration of subunit or inactivated vaccine in last 14 days, such as pneumococcal Vaccine
- •Current anti-tuberculosis prophylaxis or therapy
- •Fever (axillary temperature 38.0℃) in 3 days before vaccination or any acute disease, systemic application of antibiotics or antiviral therapy in the past five days
- •Unable to comply with the study requirements due to the psychological situation, a past or present history of mental disease, two-stage affective psychosis which were not well controlled in the past two years; mental disease need medical treatment, and have suicidal tendency over the past five years
- •Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
结局指标
主要结局
Occurrence of adverse reactions after vaccination
时间窗: within 7 days after each vaccination
Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
时间窗: 7 months after the first vaccination
Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination
次要结局
- Occurrence of adverse events after each vaccination(within 28 days after each vaccination)
- The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.(7 months after the first vaccination)
- Occurrence of serious adverse events after the vaccination.(within 12 months after the first vaccination)
研究者
研究点 (1)
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