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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy (IV and oral) |
| ||
| Immunotherapy |
| ||
| Chemotherapy + Immunotherapy |
| ||
| Cyclin- dependent kinase (CDK) 4/6 inhibitors |
| ||
| Stem Cell Transplant recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | Per recommended dosing schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts | Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201. |
| Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 |
| Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 |
| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 |
| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric median, minimum and maximum assay titer values for each cohort | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 |
| Geometric median, minimum and maximum assay titer values for each cohort |
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Inclusion Criteria:
Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4
Exclusion Criteria:
* Life expectancy of < 12 months
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Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Qamar Khan, MD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center, Westwood Campus | Kansas City | Kansas | 66205 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | 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 |
| Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| Geometric median, minimum and maximum assay titer values for each cohort | Elecsys Anti SARS CoV 2 S quantitative assay | 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 ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 |
| The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 |
| The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | 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 | Elecsys Anti SARS CoV 2 quantitative assay | 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 | Elecsys Anti SARS CoV 2 quantitative assay | 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 | Elecsys Anti SARS CoV 2 quantitative assay | 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 | Elecsys Anti SARS CoV 2 quantitative assay | 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 | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |