Cancer Clinical Trial
Official title:
Safety and Efficacy of Booster Doses of BNT162b2 Vaccine in Immunocompromised Patients With a Cancer Diagnosis
The goal of this study is to assess the safety and effectiveness of a COVID vaccine booster in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID vaccination series
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Above the age of 18 - Known diagnosis of any malignancy- either active or completed therapy - Underwent an in-person encounter at a study facility during the study period - Have a negative SARS-CoV-2 spike IgG at least 14 days after the second dose of the mRNA-based vaccines (Moderna or Pfizer/BioNTech) or 28 days after a single dose of the adenovirus-based Johnson & Johnson vaccine. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center | Albert Einstein College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of seroconversion for SARS-CoV-2 spike antibody | 4 weeks after booster dose |
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