ISRCTN89951424已完成3 期
A phase III randomized controlled trial to determine safety, efficacy, and immunogenicity of the non-replicating ChAdOx1 nCoV-19 vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10,300
研究概览
简要总结
2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33306989/ interim results (added 09/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33617777/ results (added 23/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35779491/ exploratory analysis of responses in males and females (added 04/07/2022) Other publications in https://pubmed.ncbi.nlm.nih.gov/34615860/ post-hoc exploratory analysis of the vaccine against the SARS-CoV-2 lineages circulating (added 14/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 25/11/2020:
- •1. Adults aged 18 to 55 years of age
- •2. Adults aged 56-69 years old (after review of safety data by DSMB in this age group in the UK trial)
- •3. Adults aged 70 and above years old (after review of safety data by DSMB in this age group in the UK trial)
- •4. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •5. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures
- •4. For females of childbearing potential 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
- •5. Agreement to refrain from blood donation during the course of the study
- •6. Provide written informed consent
- •7. Health professionals and/or adults at high risk of exposure to SARS-CoV-2
- •Previous inclusion criteria:
- •1. Adults aged 18 to 55 years of age. Upper age can be extended upon the availability of additional safety data in an older population
- •2. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •3. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures
- •4. For females of childbearing potential 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
- •5. Agreement to refrain from blood donation during the course of the study
- •6. Provide written informed consent
排除标准
- •1. Participation in COVID-19 prophylactic drug trials for the duration of the study. Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The study team should be informed as soon as possible
- •2. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in COV003 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- •3. Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 30 days before and after study vaccination
- •4. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines)
- •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; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months except topical steroids or short-term oral steroids (course lasting =14 days)
- •7. History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY or paracetamol
- •8. Any history of angioedema
- •9. Any history of anaphylaxis
- •10. Pregnancy, lactation or willingness/intention to become pregnant during the study
- •11. Current diagnosis of or treatment for 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. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •14. Suspected or known current alcohol or drug dependency
- •15. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- •16. History of laboratory-confirmed COVID-19
- •17. Seropositive for SARS-CoV-2 antibodies before enrolment
- •18. New onset of fever or a cough or shortness of breath or anosmia/ageusia since February 2020, unless seronegative for SARS-CoV-2 antibodies at screening
- •19. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
- •20. 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
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