ISRCTN72157798招募中1 期
A Phase Ia randomised double-blinded placebo-controlled study of a Bundibugyo virus disease vaccine, ChAdOx1 Ebola BDBV Vaccine (Recombinant), in healthy volunteers aged 18–55 years in the UK
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Adults aged between 18 and 55 years (inclusive) at the time of screening.
- •Medically healthy, such that according to investigator judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable.
- •Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diary cards.
- •Willing and able to give informed consent for participation in the study.
- •Willing to allow confirmation of past medical history either through provision of or access to a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical history from their GP practice or access it via electronic patient records.
- •Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study.
- •Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS).
- •Agreement to refrain from blood donation during the study.
- •For participants of childbearing potential only: willing to use highly effective contraception for the duration of the study AND to have a pregnancy test on the days of screening and vaccination and at the final visit. The pregnancy tests taken prior to vaccination must be negative.
排除标准
- •Receipt of an investigational product within 12 weeks prior to enrolment or planned within the trial period.
- •Participation in another research study, in which procedures performed could compromise the integrity of this study, such as exposure to a different study IMP or significant volumes of blood taken, or are planning to do so within the trial period.
- •History of previous confirmed or suspected filovirus infection.
- •History of travel within 42 days of enrolment, or planned travel within study period, to countries currently reporting filovirus outbreaks as declared by the WHO (e.g., the Democratic Republic of the Congo and Uganda)
- •Prior receipt of a vaccine targeting filoviruses, including licensed and investigational vaccines
- •Prior receipt of a ChAdOx1- or ChAdOx2-vectored vaccine
- •Administration of immunoglobulins and/or any blood products within 3 months preceding the planned administration of the vaccine candidate.
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months; or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate).
- •History of anaphylaxis or severe reaction in relation to vaccination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including hypersensitivity to the active substance or to any of the excipients of the IMP.
- •History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of any serious psychiatric condition likely to affect participation in the study.
- •Participants who are pregnant, breastfeeding or lactating or are planning pregnancy during the study.
- •History of a bleeding disorder (e.g., Factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following IM injections or venepuncture.
- •History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome; or history of heparin-induced thrombocytopenia.
- •History of capillary leak syndrome.
- •History of Guillian-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome.
- •History of currently active autoimmune conditions of any severity requiring treatment or on-going medical follow
- •Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological, immunological, endocrine disorder, or neurological illness. Well-controlled comorbidities in a healthy participant are acceptable as judged by the Investigator.
- •Suspected or known current alcohol abuse, as per investigator’s discretion.
- •Suspected or known injecting drug use within the 5 years preceding enrolment.
- •Acute or chronic hepatitis B or hepatitis C infection.
- •Any clinically significant finding on screening that is either unlikely to resolve or does not resolve (for example, on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study.
- •Any other significant disease, disorder
研究者
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