Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
研究概览
简要总结
T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients.
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
- 否
入选标准
- •Male or female patients
- •Age ≥ 18 years
- •Not having developed a symptomatic form of COVID-19 within the last 3 months before inclusion
- •Eligible to the vaccination against SARS-CoV-2
- •Affiliation to French social security or receiving such a regime,
- •Signed informed consent
- •Ability to comply with the study protocol, in the Investigator's judgment
- •Cancer patients
- •Patients under active anticancer treatment: in adjuvant or neoadjuvant setting or in first line of treatment in metastatic setting. Except for prostate cancer (until metastatic castration-resistant prostate cancer); and breast cancer hormonal receptor positive/HER2 negative (until apparition of hormonal resistance).
- •Patients in follow-up (active treatment < 3 months).
- •Age ≥ 70 years old
- •Healthy person:
- •Age ≥ 18 years old and < 70 years old
排除标准
- •Patient under guardianship, guardianship or under the protection of justice
- •Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study.
结局指标
主要结局
Rate of virus-specific IgG at 3 months following COVID-19 vaccination measured in plasma to assess humoral immune responses
时间窗: 2 years
次要结局
- Magnitude of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination(2 years)
- Frequency of SARS-CoV-2 specific T-cell at 3 and 6 months following COVID-19 vaccination(2 years)
- Rate of virus-specific IgG at 6 months following COVID-19 vaccination measured in plasma to assess humoral immune responses.(2 years)