ISRCTN69254139已完成2 期
A single-blind, randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 830
研究概览
简要总结
2021 Interim results article in https://doi.org/10.1016/S0140-6736(21)01115-6 early results of reactogenicity data (added 18/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34370971/ (added 10/08/2021) 2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35690076/ Exploratory analysis (added 13/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =50 years
- •2. In good health or have well-controlled or mild-moderate comorbidity, as determined by a trial clinician
- •3. Willing and able to give written informed consent for participation in the trial
- •4. Those of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation
- •5. Able and willing to comply with all trial requirements, in the Investigator's opinion
- •6. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial
- •7. Willing to allow investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures
- •8. Agreement to refrain from blood donation during the course of the study
排除标准
- •1. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine)
- •2. Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines)
- •3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines
- •4. Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections, or use of immunosuppressant medication within the past 6 months, with the exception of topical steroids or short-term oral steroids (course lasting =14 days)
- •5. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Pfizer vaccine)
- •6. Any history of anaphylaxis
- •7. Pregnancy, lactation, or willingness/intention to become pregnant within 3 months post boost vaccine
- •8. Current diagnosis of or treatment for cancer (with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ)
- •9. Bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •10. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and edoxaban)
- •11. Suspected or known current alcohol or drug dependency
- •12. 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
- •13. 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)
- •14. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion
- •15. History of laboratory-confirmed COVID-19 prior to enrolment (history of SARS-CoV-2 detection by PCR or antibody to SARS-CoV-2)
- •16. Significant renal or hepatic impairment
- •17. Scheduled elective surgery during the trial
- •18. Life expectancy of <6 months
- •19. Participation in another research trial involving an investigational product in the past 12 weeks
- •20. Insufficient level of English language to undertake all study requirements in the opinion of the Investigators
- •21. If at Visit 1 Screening & Vaccination the volunteer has either of the following, they will not be enrolled that day, however, they may be considered for enrolment later in the trial; if they recover in sufficient time:
- •21.1. Acute respiratory illness (m
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