Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
研究概览
简要总结
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- •Males and females age ≥ 18 years
- •Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.
- •Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4
- •Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
- •Therapy may be neo/adjuvant or for metastatic disease
- •Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2
排除标准
- •* Life expectancy of < 12 months
结局指标
主要结局
Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
时间窗: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
时间窗: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Elecsys Anti SARS CoV 2 S quantitative assay
Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts
时间窗: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201.
Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay
次要结局
- The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- Geometric median, minimum and maximum assay titer values for each cohort(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)
- The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs(Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209)