Booster Dose Trial
The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series.
Checked against the public recordLast updated Jul 31, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Montefiore Medical Center
- Interventions being studied
- Biological: BNT162b2 vaccine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria (Cohort 1): * Above the age of 18 * Meet one of the sub-criteria below: * Meet the CDC definition for immunocompromised status for cancer patients, i.e patients receiving active treatment for solid tumor or hematologic malignancy OR * Be a recipient of stem cell transplant or CAR-T cell therapy in the last 2 years OR * Have a negative SARS-CoV-2 spike IgG despite standard vaccination series, irrespective of active/inactive cancer status, on observation, or active therapy. * Underwent an in-person encounter at a study facility during the study period * Have received the second of the mRNA-based vaccines BNT162b2 and mRNA-1273 (Pfizer/BioNTech or Moderna, respectively) or one dose of the adenoviral Ad26CoV2.S (Johnson \& Johnson) vaccine at least 28 days before the booster dose. Exclusion Criteria (Cohort 1): * Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines. * Patients who have had a documented COVID-19 infection in the 90 days prior to starting the study Inclusion Criteria (Cohort 2): * Above the age of 18 * Have a diagnosis of prior or active malignancy, either hematological or solid tumor * Have a negative or low-level SARS-CoV-2 spike IgG after 14 days of booster vaccination series irrespective of active/inactive cancer status, on observation, or active therapy. * Have received an FDA-authorized booster dose of mRNA (BNT162b2 and mRNA-1273) vaccine at least 28 days before study enrollment. Exclusion Criteria (Cohort 2): * Patients who have had a serious adverse reaction to any prior COVID-19 vaccines resulting in emergency room visit or hospitalization, had events related to myocarditis, thrombosis and thrombocytopenia syndrome or anaphylaxis to any prior dose of the COVID-19 vaccines. * Patients who have had a documented COVID-19 infection in the 90 days prior to study enrollment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Montefiore Medical CenterThe Bronx, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2024. Always confirm current availability with the study team.