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临床试验/NCT05124509
NCT05124509已完成不适用

Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2021年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
1
主要终点
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.

时间窗: 8-12 weeks after booster vaccine

次要结局

  • Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.(8-12 weeks after booster vaccine)
  • Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.(8-12 weeks after booster vaccine)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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