跳至主要内容
临床试验/NCT04935528
NCT04935528已完成不适用

Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

Centre Georges Francois Leclerc2 个研究点 分布在 1 个国家目标入组 539 人开始时间: 2021年6月2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
539
试验地点
2
主要终点
seroprevalence of SARS-CoV-2 and ELISPOT

研究概览

简要总结

Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.

For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.

Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.

The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.

详细描述

The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).

Several cohorts are studied:

  • Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)
  • Cohort 2 of unvaccinated salaried staff (controls)
  • Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
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

  • 未提供

排除标准

  • Groups 1, 2 and 3
  • Minor or under legal protection
  • Person deprived of liberty or under guardianship (including curatorship)
  • Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons (filling in the questionnaire and taking the blood sample)
  • Refusal of the patient or employee to participate
  • pregnant or breastfeeding woman

结局指标

主要结局

seroprevalence of SARS-CoV-2 and ELISPOT

时间窗: through study completion, an average of 1 year

rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Mechanisms of Anti COVID-19 Humoral and Cellular... | 临床试验