A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Occurrence of solicited and unsolicited local and systemic adverse events
研究概览
简要总结
A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers.
Volunteers will be recruited and vaccinated in Oxford, England.
All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp). MVA HAV will be assessed at 2 different doses (5x10^7 and 2x10^8 pfu)
The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.
详细描述
This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity of the ChAdOx2 and MVA HAV vaccines against Mycobacterium avium subspecies paratuberculosis (MAP) in healthy volunteers
There will be 5 study groups with a total of 28 volunteers. ChAdOx2 HAV will be administered intramuscularly as a single vaccination at 3 different doses: 5x10^9 vp (group 1), 2.5x10^10 (group 2) and 5x10^10 vp (group 3) and as a prime vaccine in group 6 (prime/boost group). MVA HAV will be administered intramuscularly as a single vaccination at 2 different doses: 5x10^7 pfu (group 4), 2x10^8 pfu (group 5) and as a boost vaccine in group 6 (prime/boost group)
Vaccination of groups will be sequential from Group 1 to Group 6 with interim safety reviews prior to dose escalation
Volunteers will be recruited and undergo screening visits, vaccination and clinic visits post-vaccination at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances.
Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Healthy adults aged 18 to 50 years
- •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 contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- •Agreement to refrain from blood donation during the course of the study
- •Provide written informed consent
排除标准
- •Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- •Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
- •Prior receipt of an adenoviral vectored vaccine in the last 12 months
- •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
- •Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- •Any history of anaphylaxis in relation 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 likely to affect participation in the study
- •Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •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 in the 5 years preceding enrolment
- •Seropositive for hepatitis C (antibodies to HCV)
- •Seropositive for hepatitis B surface antigen(HBsAg)
- •Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
- •Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- •Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.
结局指标
主要结局
Occurrence of solicited and unsolicited local and systemic adverse events
时间窗: up to 28 days following vaccination
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. Change from baseline for safety laboratory measures will also be collected. Occurrence of serious adverse events will be collected during the whole study duration
次要结局
- Measures of Immunogenicity of ChAdOx2 HAV and MVA HAV(Approximately 2 months post each vaccination)