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临床试验/NCT05119738
NCT05119738Unknown不适用

Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年10月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
122
试验地点
1
主要终点
Proportion of positive neutralizing antibodies 8 to 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 a 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 United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.

In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.

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

  • Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
  • Eastern Cooperative Oncology group performance status < 3

排除标准

  • Previous SARS-CoV-2 infection
  • Vaccination with booster vaccine more than 12 weeks before informed consent
  • Intravenous inmunoglobulin therapy 60 days before informed consent
  • Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.

结局指标

主要结局

Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).

时间窗: 8 to12 weeks after third dose BNT162b2.

次要结局

  • Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)(8 to12 weeks after third dose BNT162b2.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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