Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.
This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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Santiago、智利
- Pontificia Universidad Catolica de Chile
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.
Exclusion Criteria:
- Previous SARS-CoV-2 infection
- Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
- Intravenous immunoglobulin therapy 60 days before enrolment
- Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Three doses of BNT162b2 vaccine
Solid organ transplant patients who received three doses of BNT162b2
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Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine.
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Two doses of Coronavac and one of BNT162b2 vaccine
Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2
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Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.
大体时间:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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次要结果测量
结果测量 |
大体时间 |
---|---|
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.
大体时间:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
大体时间:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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其他结果措施
结果测量 |
大体时间 |
---|---|
The number of IFN-y-spot forming T cells SARS-CoV-2 specific after third dose of BNT162b2 (booster) vaccine.
大体时间:8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 210405014E
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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