NCT01070407已完成1 期
A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ReiThera Srl
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- To assess the safety of AdCh3NSmut and Ad6NSmut, when administered in a prime/boost regimen to healthy volunteers. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
研究概览
简要总结
HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region).
The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies.
The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •Healthy adults aged 18 to 50 years (inclusive)
- •Resident in or near the trial sites for the duration of the vaccination study
- •Able and willing (in the Investigator's opinion) to comply with all study requirements
- •Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- •For females only, willingness to practice continuous effective barrier contraception during the study and a negative pregnancy test on the day(s) of vaccination
- •For men to use barrier contraception until three months after the last vaccination
- •Agreement to refrain from blood donation during the course of the study
- •Written informed consent
排除标准
- •The volunteer may not enter the study if any of the following apply:
- •Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- •Prior receipt of a recombinant simian or human adenoviral vaccine
- •Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., Kathon
- •History of clinically significant contact dermatitis
- •Any history of anaphylaxis in reaction to vaccination
- •Pregnancy, lactation or willingness/intention to become pregnant during the study
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •History of serious psychiatric condition
- •Any other serious chronic illness requiring hospital specialist supervision
- •Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- •Suspected or known injecting drug abuse
- •Seropositive for hepatitis B surface antigen (HBsAg)
- •Seropositive for HIV (antibodies to HIV) at screening
- •Seropositive for hepatitis C virus (antibodies to HCV) at screening
- •Seropositive for simian adenovirus 3 (antibodies to AdCh3) at titres >200, at screening
- •Seropositive for human adenovirus 6 (antibodies to Ad6) at titres >200, at screening
- •Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study
- •Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- •Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol
- •Individuals who have had a temperature >38°C in the 3 days preceding vaccination.
- •Vulnerable subjects (according to the ICH E6 GCP)
结局指标
主要结局
To assess the safety of AdCh3NSmut and Ad6NSmut, when administered in a prime/boost regimen to healthy volunteers. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
时间窗: Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
次要结局
- To assess the immunogenicity of AdCh3NSmut and Ad6NSmut, when administered in prime/boost regimen to healthy volunteers. The specific endpoint of cellular immune response will be collected via IFNγ ELIspot assay and other exploratory immunological tests.(Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups)
研究者
研究点 (4)
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