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

Breast Cancer Clinical Trial

— CANINE  

Official title:

Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04821570
• Other study ID #: IIT-2021-CANINE
• Status: Active, not recruiting
• Start date: February 23, 2021
• Est. completion date: March 28, 2025

Study information

• Verified date: April 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 28, 2025
• Est. primary completion date: March 28, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• COVID-19 Vaccine
Per recommended dosing schedule

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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