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PI had decided to terminate the study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients with solid tumors receiving courses of cytotoxic therapy. |
| |
| Group 2 | Patients with hematological cancers receiving courses of cytotoxic chemotherapy. |
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| Group 3 | Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months |
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| Group 4 | Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months |
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| Group 5 | Patients receiving immune checkpoint inhibitors. |
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| Group 6 | Patients who underwent allogeneic stem cell transplant within 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccination | Biological | Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Collection | from date of vaccination until 2 months after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 infection | from date of vaccination until 6 months after full vaccination |
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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:
3. Estimated survival of 8 weeks or more following enrollment on the study.
Exclusion Criteria:
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Patients with a current or previous cancer diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Utpal Dave, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center | Carmel | Indiana | 46032 | United States | ||
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000719707 | heterologous prime boost COVID-19 vaccination |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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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.
| Group 7 | Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months. |
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| Group 8 | Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches |
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| Group 9 | Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted). |
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| Group 10 | Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants |
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| Group 11 | Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants |
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| Group 12 | Patients who have a cancer diagnosis but do not fall into group 1-11 |
|
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |