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

Terminated

• Conditions: Cancer
• Interventions: Biological: COVID-19 Vaccination

• Registration Number: NCT04930055
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-18
• Study Start: 2021-06-30
• Primary Completion: 2021-11-01
• Study Completion: 2022-03-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2206

Inclusion Criteria

1. Ability to provide written informed consent and HIPAA authorization

2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.

3. Subjects must be ≥ 18 years old at the time of consent.

4. Diagnosis of cancer and fall into one of the groups below:

   1. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
   2. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
   3. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
   4. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
   5. Group 5: Patients receiving immune checkpoint inhibitors.
   6. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
   7. 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.
   8. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
   9. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
   10. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
   11. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
   12. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11

5. Estimated survival of 8 weeks or more following enrollment on the study.

Exclusion Criteria

1. 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
2. Unwilling or unable to follow protocol requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	COVID-19 Vaccination	Patients with solid tumors receiving courses of cytotoxic therapy.
Group 7	COVID-19 Vaccination	Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.
Group 8	COVID-19 Vaccination	Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches
Group 4	COVID-19 Vaccination	Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
Group 10	COVID-19 Vaccination	Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
Group 11	COVID-19 Vaccination	Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
Group 2	COVID-19 Vaccination	Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
Group 3	COVID-19 Vaccination	Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months
Group 5	COVID-19 Vaccination	Patients receiving immune checkpoint inhibitors.
Group 9	COVID-19 Vaccination	Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
Group 12	COVID-19 Vaccination	Patients who have a cancer diagnosis but do not fall into group 1-11
Group 6	COVID-19 Vaccination	Patients who underwent allogeneic stem cell transplant within 12 months.

Primary Outcome Measures

Name	Time	Method
Adverse Event Collection	from date of vaccination until 2 months after full vaccination

Secondary Outcome Measures

Name	Time	Method
Incidence of COVID-19 infection	from date of vaccination until 6 months after full vaccination

Trial Locations

Locations (2)

IU Health Joe and Shelly Schwarz Cancer Center; 🇺🇸 Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States