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临床试验/NCT04936997
NCT04936997已完成早期 1 期

Immune Response to the COVID-19 Vaccine

University of Arizona2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月7日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Immune response

研究概览

简要总结

Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

详细描述

In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients must have active solid tumor malignancy diagnosis
  • On active chemotherapy
  • Received two prior SARS-COV2 Pfizer vaccines
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent
  • Agree to comply with study procedures
  • Subjects previously enrolled under the main study

排除标准

  • History of HIV or organ/bone marrow transplant
  • Actively receiving immunotherapy
  • On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
  • Currently incarcerated or residence of another state
  • Speaks a language other than English.

结局指标

主要结局

Immune response

时间窗: 3 months

Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.

次要结局

  • Adverse events(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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