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

Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)

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 Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Lung Cancer; Melanoma (Skin)
• Intervention / Treatment: Biological: COVID-19 Vaccine

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Westwood Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immunotherapy	Biological: COVID-19 Vaccine; Per recommended dosing schedule
Chemotherapy (IV and oral)	Biological: COVID-19 Vaccine; Per recommended dosing schedule
Chemotherapy + Immunotherapy	Biological: COVID-19 Vaccine; Per recommended dosing schedule
Cyclin- dependent kinase (CDK) 4/6 inhibitors	Biological: COVID-19 Vaccine; Per recommended dosing schedule
Stem Cell Transplant recipients	Biological: COVID-19 Vaccine; Per recommended dosing schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Qamar Khan, MD, University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Anticipated): March 28, 2024
• Study Completion (Anticipated): March 28, 2025

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: IIT-2021-CANINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No