Double Blind, Randomized, Multicenter, Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine Together With Polyarginine, HCV Peptide Vaccine Alone, or Polyarginine Alone, in Patients With Chronic HCV Having Not Responded to or Relapsed From Primary Standard HCV Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Immunological assays
研究概览
简要总结
The objectives are
- to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
- to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
- to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
详细描述
This is a double blind, randomized, parallel group, controlled, multicenter phase II study.
60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.
Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.
The volume of each injection will be 0.5 ml in all groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic hepatitis C
- •Non-response to or relapse from primary standard HCV therapy
- •HLA A2 positive
- •HCV-RNA positive
- •HCV antibodies positive
- •Liver biopsy within 30 months prior to inclusion
- •Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
- •Male and female
- •From 18 to 65 years
- •Written informed consent obtained prior to study entry
排除标准
- •Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
- •Any liver disease other than hepatitis C
- •History of autoimmune disease
- •Immunodeficiency including post-organ-transplantation
- •HIV infection
- •Immunosuppressive therapy
- •Any acute infections within 4 weeks prior to inclusion
- •History of severe hypersensitivity reactions, anaphylaxis or atopy
- •Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
- •Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
- •Pregnancy or lactation
- •Unreliable contraception
- •Alcohol consumption
- •Drug abuse or addiction within 12 months prior to inclusion
- •Participation in a methadone program
- •Participation in another study within 1 month prior to enrolment
研究组 & 干预措施
IC41-G-01/02
peptide dose: 2.50 mg, polyarginine dose: 1.25 mg
干预措施: IC41 (Biological)
IC41-K-01/02
peptide dose: 5.00 mg, polyarginine dose: 2.00 mg
干预措施: IC41 (Biological)
IC41-H-01/02
peptide dose: 2.50 mg, polyarginine dose: 2.00 mg
干预措施: IC41 (Biological)
IC41-C-01/02
peptide dose: 5.00 mg, polyarginine dose: 0.00 mg
干预措施: IC41 (Biological)
IC41-B-01/02
peptide dose 0.00 mg, polyarginine dose 2.00 mg
干预措施: IC41 (Biological)
结局指标
主要结局
Immunological assays
时间窗: study duration
次要结局
- Safety(study duration)