ISRCTN26495549进行中（未招募）4 期
A phase IV, multi-centre, randomised controlled trial to assess immunogenicity and safety of COVID-19 and seasonal influenza vaccine given to healthy adults or those with underlying medical conditions when co-administered with a recombinant herpes zoster vaccine with adjuvant
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 1,032 人开始时间: 2023年5月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,032
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
- •Current inclusion criteria as of 23/11/2023:
- •1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •2. Written informed consent obtained from the participant prior to any study-specific procedure
- •3. Adults aged 50 years and over at the time of randomisation
- •4. Participants must have documented history (e.g. NHS app, GP record) or receiving their initial course (usually two doses) of any type of COVID-19 vaccinaiton, irrespective of the type of COVID-19 vaccine received.
- •5. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first vaccination continuously until 3 months after final vaccination*
- •*A woman of childbearing potential is defined as a pre-menopausal female who is capable of becoming pregnant
- •Previous inclusion criteria:
- •1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- •2. Written informed consent obtained from the participant prior to any study-specific procedure
- •3. Adults aged 50 years and over at the time of randomisation
- •4. Participants must have documented previous COVID-19 vaccination in line with UK recommendations at the time of the study
- •5. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first vaccination continuously until 3 months after final vaccination*
- •*A woman of childbearing potential is defined as a pre-menopausal female who is capable of becoming pregnant
排除标准
- •Current exclusion criteria as of 23/11/2023:
- •1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study
- •2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, Guillain-Barre Syndrome
- •3. Unstable medical condition on the day of enrolment as determined by clinical history and examination
- •4. Bleeding disorders
- •5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination. People living with HIV that is well controlled can be included in the study.* Those with a new diagnosis or an AIDs defining illness in the past 12 months cannot be included.
- •6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20 mg/day or equivalent. Use of inhaled, intra-articular and topical steroids is allowed.
- •7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab)
- •8. COVID-19 or influenza vaccination 90 days prior to study vaccination
- •9. Previous vaccination with a live herpes zoster vaccine within the past 5 years
- •10. Administration of monoclonal antibodies (including those targeting SARS-CoV-2), immunoglobulins and/or blood products during the 3 months before the first dose of the study vaccines, up to 1 month after the last dose or planned during the study period
- •11. Planning to or concurrently participating in another interventional clinical study
- •12. Pregnancy, lactation or willingness/intention to become pregnant within the study period
- •13. COVID-19 or flu vaccine within 90 days, any other vaccine within 30 days of study vaccination
- •*Defined as less than 50 copies/ml (convert as needed from IU/ml) on the last two occasions >3 months apart, and a CD4 over 500 when last checked.
- •Previous exclusion criteria:
- •1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study
- •2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, Guillain-Barre Syndrome
- •3. Unstable medical condition on the day of enrolment as determined by clinical history and examination
- •4. Bleeding disorders
- •5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination
- •6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20 mg/day or equivalent. Use of inhaled, intra-articular and topical steroids is allowed.
- •7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab)
- •8. Planned vaccination within 30 days of study vaccination
- •9. Previous vaccination with a live herpes zoster vaccine within the past 5 years
- •10. Administration of monoclonal antibodies (i
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