A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)
A Phase I Study to Assess the Safety and Immunogenicity of New Hepatitis C Virus Vaccine Candidates AdCh3NSmut and Ad6NSmut
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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX3 7LJ
- Centre for Clinical Vaccinology and Tropical Medicine
-
-
West Midlands
-
Birmingham、West Midlands、英国、B15 2TH
- Wellcome Clinical Research Facility, Queen Elizabeth's Hospital, University Hospital Birmingham NHS Foundation Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm A, group 1
4 volunteers
|
2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
|
实验性的:Arm A, group 2
4 volunteers
|
2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
|
实验性的:Arm A, group 3
5 volunteers
|
2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
|
实验性的:Arm B, group 5
4 volunteers
|
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
|
实验性的:Arm B, group 6
4 volunteers
|
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
|
实验性的:Arm B, group 7
5 volunteers
|
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
|
实验性的:Arm C, group 9
5 volunteers
|
2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
|
实验性的:Arm C, group 10
5 volunteers
|
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
|
实验性的:Arm C, group 11
4 volunteers
|
2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
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.
大体时间:Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
|
Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
|
次要结果测量
结果测量 |
大体时间 |
---|---|
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.
大体时间:Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
|
Different time points depending on the study groups with a 6-months follow-up after last vaccination for all groups
|
合作者和调查者
赞助
调查人员
- 学习椅:Paul Klenerman, Professor、University of Oxford, UK
- 首席研究员:David Adams, Professor、University of Birmingham
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
丙型肝炎的临床试验
-
Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
-
Haisco Pharmaceutical Group Co., Ltd.完全的
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
Ad6NSmut; AdCh3NSmut的临床试验
-
ReiThera SrlUniversity of Oxford; Oxford University Hospitals NHS Trust; University Hospital Birmingham完全的
-
ReiThera SrlEuropean Commission完全的