ISRCTN17936606进行中（未招募）1 期
A Phase I study to determine the safety and immunogenicity of a new vaccine against the Middle East Respiratory Syndrome Coronavirus in Adults aged 50 to 70 years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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 50 to 70 years (inclusive) at the time of screening
- •2. Medically stable, 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. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 90 days prior to enrolment.
- •3. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
- •4. Willing to allow confirmation of their past medical history either through: provision of or access to medical record summary, allowing investigators to obtain a copy of their medical history from their GP practice or accessed via the electronic patient record or other medical documentation provided by the participant
- •5. Agreement to refrain from blood donation during the course of the study
- •6. Willing and able to give informed consent for participation in the study
- •7. For women of childbearing potential only (As defined by protocol section 8.4): Willing to use effective contraception as defined from one month prior to receiving the first vaccine and for the duration of the study AND a negative pregnancy test on the days of screening and vaccination.
- •8. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
- •9. Willing to allow his or her General Practitioner and/or Consultant, if appropriate, to be notified of participation in the study
- •10. Group 1 specific inclusion criteria: a confirmed history of receiving at least TWO doses of the ChAdOx1 nCov-19 (Oxford/AZ COVID-19) vaccine prior to enrolment
- •11. Group 2 specific inclusion criteria: no previous history of receiving ANY doses of the ChAdOx1 nCov-19 (Oxford/AZ COVID-19) vaccine prior to enrolment
排除标准
- •1. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study) in the past 12 weeks, or are planning to do so within the trial period
- •2. Planned receipt of another adenoviral vectored vaccine (e.g. Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days of any study vaccine.
- •3. Previous immunisation with an investigational MERS vaccine
- •4. History of prior confirmed or suspected MERS infection
- •5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infections or 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 days consecutively within the previous 3 months)
- •7. 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 or Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine)
- •8. History of allergic reaction to aminoglycoside antibiotics
- •9. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- •10. History of anaphylaxis in relation to vaccination
- •11. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •12. History of serious psychiatric condition likely to affect participation in the study
- •13. Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study
- •14. Bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •15. 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
- •16. Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria (i.e. the Oxford/AstraZeneca COVID-19 vaccine)
- •17. Individuals who have previously experienced episodes of capillary leak syndrome
- •18. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator (note, mild/moderate well-controlled comorbidities are allowed)
- •19. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- •20. Suspected or known injecting drug abuse in the 5 years preceding enrolment
- •21. Detectable circulating hepatitis B surface antigen (HBsAg)
- •22. Seropositive for hepatitis C virus (antibodies to HCV)
- •23. Any clinically significant finding on screening investigations, that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study
- •24. 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 i
研究者
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