ISRCTN87634044进行中（未招募）1 期
A Phase I safety and immunogenicity study of a Nipah virus vaccine, ChAdOx1 NipahB, in healthy volunteers aged 18 to 55 years in the UK
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults aged between 18 to 55 years (inclusive) at the time of screening.
- •2. 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
- •3. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of electronic diary cards
- •4. Willing and able to give informed consent for participation in the study
- •5. 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 accessed via electronic patient records
- •6. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study
- •7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
- •8. Agreement to refrain from blood donation during the course of the study
- •9. For women of childbearing potential only: willing to use effective contraception from one month prior to receiving the first dose of vaccine and for the duration of the study AND have a negative pregnancy test on the days of screening and vaccination
排除标准
- •1. Participation in another research study involving an investigational product or other study which includes procedures that could compromise the integrity of this study (such as significant volumes of blood already taken) within the 12 weeks prior to enrolment, or are planning to do so within the trial period
- •2. Previous receipt of another adenoviral-vectored vaccine (which includes the Oxford/AstraZeneca and Janssen COVID-19 vaccines) within the preceding year
- •3. Previous immunisation with an investigational Nipah vaccine
- •4. History of previous confirmed or suspected Nipah infection
- •5. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate.
- •6. 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 3 months preceding the planned administration of the vaccine candidate)
- •7. History of anaphylaxis in relation to vaccination
- •8. 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 (EDTA or magnesium chloride)
- •9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- •10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •11. History of any serious psychiatric condition likely to affect participation in the study
- •12. For women only: participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the course of the study
- •13. 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
- •14. 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
- •15. History of capillary leak syndrome
- •16. Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological, immunological, endocrine disorder, or neurological illness (note, mild well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator)
- •17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units per week
- •18. Suspected or known injecting drug use within the 5 years preceding enrolment
- •19. Detectable circulating hepatitis B surface antigen (HBsAg)
- •20. Seropositive for hepatitis C virus (antibodies to HCV)
- •21. 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
研究者
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