Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

NCT04930055 | Terminated DMC

• 1 other identifier: CTO-IUSCCC-0759
• Study Type: observational
• Target: 2,206
• Locations: 1 country
• Sites: 2

Brief Summary

The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines.

Conditions

Cancer

Keywords

COVID-19; Vaccine; Pfizer; Moderna; Janssen; COVID

Outcome Measures

Primary Outcomes (1)

• Adverse Event Collection

  from date of vaccination until 2 months after full vaccination

Secondary Outcomes (1)

• Incidence of COVID-19 infection

  from date of vaccination until 6 months after full vaccination

Study Arms (12)

Group 1

Patients with solid tumors receiving courses of cytotoxic therapy.

Biological: COVID-19 Vaccination

Group 2

Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

Biological: COVID-19 Vaccination

Group 3

Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

Biological: COVID-19 Vaccination

Group 4

Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

Biological: COVID-19 Vaccination

Group 5

Patients receiving immune checkpoint inhibitors.

Biological: COVID-19 Vaccination

Group 6

Patients who underwent allogeneic stem cell transplant within 12 months.

Biological: COVID-19 Vaccination

Group 7

Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.

Biological: COVID-19 Vaccination

Group 8

Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches

Biological: COVID-19 Vaccination

Group 9

Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).

Biological: COVID-19 Vaccination

Group 10

Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

Biological: COVID-19 Vaccination

Group 11

Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

Biological: COVID-19 Vaccination

Group 12

Patients who have a cancer diagnosis but do not fall into group 1-11

Biological: COVID-19 Vaccination

Interventions

COVID-19 Vaccination BIOLOGICAL

Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care

Also known as: Moderna (mRNA-1273), Pfizer (BTN162b2), Janssen (Ad26.COV2.S)

Group 1; Group 10; Group 11; Group 12; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7; Group 8; Group 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a current or previous cancer diagnosis

You may qualify if:

• Ability to provide written informed consent and HIPAA authorization
• Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
• Subjects must be ≥ 18 years old at the time of consent.
• Diagnosis of cancer and fall into one of the groups below:
• Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
• Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
• Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
• Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
• Group 5: Patients receiving immune checkpoint inhibitors.
• Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
• Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.
• Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
• Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
• Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
• Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days
• Unwilling or unable to follow protocol requirements.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Collection at Dose 1, Dose 2, and +1 month, +3 months, +6 months and +12 months after their Dose 2 and/or at booster dose and +1 month, +3 months, +6 months and +12 months after their booster dose for Pfizer/Moderna vaccinations. Collection at Dose 1 and +1 month, +3 months, +6 months and +12 months after their Dose 1 and/or at booster dose and +1 month, +3 months, +6 months and +12 months after their booster dose for Janssen vaccinations. PBMC Collection at Dose 1 and +3 months after Dose 2 for Moderna/Pfizer vaccinations and at Dose 1 and +3 months after Dose 1 for Janssen vaccinations and/or at booster dose and +6 months after booster dose of either. Serum and peripheral blood mononuclear cells (PBMC) will be cryopreserved for molecular and immunologic studies that can include, but are not limited, to antibody titers, cytokines and chemokines, immune cell subsets and T cell and B cell analysis.

MeSH Terms

Conditions

Neoplasms; COVID-19

Interventions

heterologous prime boost COVID-19 vaccination; 2019-nCoV Vaccine mRNA-1273; Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Utpal Dave, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Medicine Division of Hematology/Oncology

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: June 30, 2021
• Primary Completion: November 1, 2021
• Study Completion: March 8, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)