ISRCTN12348322进行中（未招募）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 in adolescents
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 429
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37331429/ (added 20/07/2023)
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 25/05/2022:
- •For Cohort A:
- •1. Aged 12 to 16 years (inclusive) at enrolment
- •For Cohort B:
- •1. Aged 12 to 15.5 years (inclusive) at enrolment
- •2. Already received two doses of 30 µg BNT162b2, the second dose received at least 91 days prior to randomisation
- •For Cohorts A and B:
- •1. In good health as determined by a trial clinician. Participants may have well-controlled or mild to moderate comorbidity, as long as this would not render them considered as belonging to a 'high-risk' cohort at particular need of additional doses of COVID-19 2. Able and willing (in the Investigator's opinion) to comply with all study requirements
- •3. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
- •4. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial. Parent/legal guardian to provide informed consent for participants under the age of 16. Participants aged 16 years will be assumed to be able to provide consent for themselves, however parental support will be encouraged and investigators will reserve the right to refuse enrolment if concerns arise.
- •Previous participant inclusion criteria as of 19/11/2021:
- •1. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial
- •2. Aged 12 to 16 years inclusive at enrolment
- •3. In good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity, as long as this would not render them considered as belonging to a ‘high -risk’ cohort at particular need of 2 doses of COVID-19 vaccine (see exclusion criteria below) as part of the national roll out
- •4. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •5. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
- •Previous participant inclusion criteria:
- •1. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial
- •2. Aged 12 to 16 years inclusive at enrolment
- •3. In good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity, as long as this would not render them eligible for 2 doses of COVID-19 vaccine (see exclusion criteria below) as part of the national roll out
- •4. Able and willing (in the Investigator’s opinion) to comply with all study requirements
- •5. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
排除标准
- •Current participant exclusion criteria as of 24/11/2022:
- •For Cohort A:
- •1. Previous receipt of more than one dose of a COVID-19 vaccine, or a COVID-19 vaccine other than BNT162b2
- •For Cohort B:
- •1. Previous receipt of more than two doses of a COVID-19 vaccine, or a COVID-19 vaccine other than BNT162b2 30 µg
- •2. Previous receipt of the 4CMenB vaccine
- •3. Participants in Cohort A are not eligible to be enrolled into Cohort B unless they received two full doses of BNT162b2 in Cohort A, and they have completed the Cohort A day 236 study visit. At this point they are eligible to enrol in Cohort B, in which case they will be treated as a new participant and receive a new, unrelated, participant number.
- •For Cohorts A and B:
- •1. Belonging to a 'high- risk' cohort advised to receive additional doses of a COVID-19 vaccine (participants at increased risk of COVID-19, or household contacts of immunocompromised, based on JCVI and 'Green Book' guidelines current on 28/02/2022).
- •2. First-degree relative of study team member
- •3. 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)
- •4. History of anaphylaxis, 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/IB-listed ingredients of any study vaccine). This includes latex and polyethylene glycol/macrogol (PEG).
- •5. Pregnancy, lactation or unwillingness to practice effective contraception from enrolment to 3 months post-study vaccination (for post-menarcheal females only)
- •6. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/haematological malignancy within the 6 months prior to consent
- •7. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •8. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
- •9. Any serious chronic illness requiring hospital specialist supervision
- •10. Congenital cardiovascular conditions
- •11. Severe and/or uncontrolled respiratory disease, gastrointestinal disease, liver disease, renal disease, rheumatological disease, and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- •12. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis)
- •13. Significant renal or hepatic impairment
- •14. Scheduled elective surgery requiring overnight admission and/or general anaesthetic during the trial
- •15. Insufficient level of English language to undertake all study requirements in the opinion of the Investigators
- •16. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines
- •17. Participants who have participated in another research trial involving an investigational product in the past 12 weeks (see exclusion criteria above for enrolment into Cohort B after participation in Cohort A of this study)
- •18. Note that a prior history of confirmed or suspected COVID-19 is NOT an exclusion criterion for this study, provided the particip
研究者
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