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

Active, not recruiting

• Conditions: Breast Cancer; Melanoma (Skin); Lung Cancer
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT04821570
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-23
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-03-28
• Study Completion: 2025-03-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy	COVID-19 Vaccine	-
Chemotherapy (IV and oral)	COVID-19 Vaccine	-
Cyclin- dependent kinase (CDK) 4/6 inhibitors	COVID-19 Vaccine	-
Stem Cell Transplant recipients	COVID-19 Vaccine	-
Chemotherapy + Immunotherapy	COVID-19 Vaccine	-

Primary Outcome Measures

Name	Time	Method
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 Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209	Elecsys Anti SARS CoV 2 S quantitative assay
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

Secondary Outcome Measures

Name	Time	Method
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
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 ≥ 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
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

Trial Locations

Locations (1)

The University of Kansas Cancer Center, Westwood Campus; 🇺🇸 Kansas City, Kansas, United States