To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment

University of Kansas Medical Center500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Breast Cancer Lung Cancer Melanoma (Skin)

Interventions

COVID-19 VaccineBIOLOGICAL

Per recommended dosing schedule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201

Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline

Data from ClinicalTrials.gov

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Secondary Outcomes

Geometric median, minimum and maximum assay titer values for each cohort

Elecsys Anti SARS CoV 2 S quantitative assay

Time frame: 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

Elecsys Anti SARS CoV 2 S quantitative assay

Time frame: 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

Time frame: 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