ISRCTN73765130已完成2 期
A randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against ancestral and novel variants of SARS-CoV-2
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 2,878 人开始时间: 2021年5月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,878
研究概览
简要总结
2021 Results article in https://doi.org/10.1016/S0140-6736(21)02717-3 28-day results of third dose (added 03/12/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35550261/ 28-day results of fourth dose (added 16/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35405168/ 3-month results of third dose (added 21/04/2023) 2023 Results article in https://doi.org/10.1016/j.jinf.2023.04.012 8-month results of third dose (added 21/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 17/08/2022:
- •1. Willing and able to give written informed consent for participation in the trial.
- •2. Aged 30 years or above and in good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity.
- •3. Female participants 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
- •4. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •5. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial
- •6. 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.
- •7. Agreement to refrain from blood donation during the study
- •8. Received priming dose of COVID-19 vaccination between December 2020 and January 2021 (inclusive) and booster dose no less than 84 days prior to day 0. Due to the NHS deployment timelines, some sites may need to invite people who have been prime-boosted with their second dose of AstraZeneca with a minimum of 70 days from their second dose. Sites need Sponsor approval for this prior to enrolment of people with a 70-83 day gap since their second dose in any study arm
- •For the External Vaccine Trial Participants sub-study, the inclusion criteria are:
- •1. Willing and able to give written informed consent for participation in the trial
- •2. Male or female aged 30 years or above
- •3. In the Investigator’s opinion, is able and willing to comply with all trial requirements
- •4. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial
- •5. 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
- •6. Primary immunization course (2 doses) of NVXCoV2373 COVID-19 vaccine
- •7. Plans to receive 1 or 2 doses of licensed vaccine (1 dose will be received as part of this trial, the second dose will not be provided by the trial but the participant may receive a second dose via the NHS if they wish to).
- •For the Fourth dose sub-study, the inclusion criteria are:
- •1. Participants from the main study in Group B who received a 3rd dose booster of BNT162b2 (regardless of whether primary course was BNT162b2 or ChAdOx1-nCov19) will be invited to participate.
- •2. Participants will be eligible for booster vaccination at the Fourth Dose Booster Sub-Study unless they have had a previous severe adverse reaction to mRNA vaccines or have acquired an additional COVID-19 vaccine outside of the study since enrolling. Other medical criteria will be checked prior to immunisation (including diagnosis of cancer, autoimmune conditions, neurological conditions, blood clotting conditions and pregnancy), but will not be considered a contraindication to vaccination unless the investigator feels there is a specific clinical reason to withhold vaccination for the safety of the participant.
- •For the young adult fractional dosing sub-study, the inclusion criteria are:
- •1. Participant is willing and able to give written informed consent for participation in the trial.
- •2. Male or Female, aged 18 to 30 years and in good health as determined by a trial clinician. Participant
排除标准
- •Current participant exclusion criteria as of 17/08/2022:
- •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 any other 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. Pregnant at enrolment or planning to become pregnant during the first 3 months of the trial period
- •4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines
- •5. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days)
- •6. 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)
- •7. Any history of anaphylaxis
- •8. Current diagnosis of or treatment for cancer, except 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. History of cerebral venous sinus thrombosis, antiphospholipid syndrome, or heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2)
- •12. Suspected or known current alcohol or drug dependency
- •13. 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
- •14. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- •15. 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.
- •16. Significant renal or hepatic impairment
- •17. Scheduled elective surgery during the trial
- •18. Life expectancy of <6 months
- •19. Have participated in another research trial involving an investigational product in the past 12 weeks. This does not exclude participants in trials of AZD1222 (ChAdOx1 nCOV-19) who were originally recipients of placebo and who received AZD1222 (ChAdOx1 nCOV-19) or BNT162b2 as part of the national schedule” with AZD1222 (ChAdOx1 nCOV-19) or BNT162b2 dose 1 from mid-Dec 2020 through end February 2021 and then AZD1222 (ChAdOx1 nCOV-19) or BNT162b2 second dose 12 twelve weeks later (this is allowed by the COV001 and COV002 protocols)
- •20. Insufficient level of English language to undertake all study requirements in the opinion of the Investigators except where translation has been able to be provided and is available
- •For the External Vaccine Trial Participants Sub
研究者
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