Breast Cancer, Lung Cancer, Melanoma (Skin)
Conditions
Brief summary
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.
Interventions
BIOLOGICALCOVID-19 Vaccine
Per recommended dosing schedule
Sponsors
University of Kansas Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
\* Life expectancy of \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts | 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 |
| Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: 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 | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 S quantitative assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
| Geometric median, minimum and maximum assay titer values for each cohort | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 S quantitative assay |
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
| 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 Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | Elecsys Anti SARS CoV 2 quantitative assay |
Countries
United States
Outcome results
None listed