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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04821570

Collaborator

(none)

500

Enrollment

Location

37.1

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Lung Cancer Melanoma (Skin)	Biological: COVID-19 Vaccine

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)

Actual Study Start Date :

Feb 23, 2021

Anticipated Primary Completion Date :

Mar 28, 2023

Anticipated Study Completion Date :

Mar 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy (IV and oral)	Biological: COVID-19 Vaccine Per recommended dosing schedule
Immunotherapy	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

Outcome Measures

Primary Outcome Measures

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 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 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 [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 Pfizer baseline, Day 21, Day 51, Day 111, Day 201]
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 Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209]
Elecsys Anti SARS CoV 2 S quantitative assay

Secondary Outcome Measures

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
Geometric median, minimum and maximum assay titer values for each cohort [Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
Elecsys Anti SARS CoV 2 S quantitative assay
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]
Elecsys Anti SARS CoV 2 S 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
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
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 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 ≥ 2 from baseline at each post injection time points with 95% CIs [Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
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 Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
Elecsys Anti SARS CoV 2 quantitative assay
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 Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
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 Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
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 Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
Elecsys Anti SARS CoV 2 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 Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201]
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 Johnson & Johnson: 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 Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209]
Elecsys Anti SARS CoV 2 quantitative assay
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]
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 Johnson & Johnson: 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 Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209]
Elecsys Anti SARS CoV 2 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 Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209]
Elecsys Anti SARS CoV 2 quantitative assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas	United States	66205

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

Principal Investigator: Qamar Khan, MD, University of Kansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT04821570

Other Study ID Numbers:

IIT-2021-CANINE

First Posted:

Mar 29, 2021

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Apr 4, 2022