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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Biological: COVID-19 Vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11 3. Estimated survival of 8 weeks or more following enrollment on the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with solid tumors receiving courses of cytotoxic therapy. | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 2<br>Patients with hematological cancers receiving courses of cytotoxic chemotherapy. | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 3<br>Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 4<br>Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 5<br>Patients receiving immune checkpoint inhibitors. | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 6<br>Patients who underwent allogeneic stem cell transplant within 12 months. | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 7<br>Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months. | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 8<br>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<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 9<br>Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted). | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 10<br>Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 11<br>Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|
| Group 12<br>Patients who have a cancer diagnosis but do not fall into group 1-11 | Biological: COVID-19 Vaccination<br>* Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care<br>* Other names: Janssen (Ad26.COV2.S);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Collection |  | from date of vaccination until 2 months after full vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 infection |  | from date of vaccination until 6 months after full vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Vaccine, Pfizer, Moderna, Janssen, COVID