Official Title
Safety and Efficacy of Booster Doses of BNT162b2 Vaccine in Immunocompromised Patients With a Cancer Diagnosis
Brief Summary

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

Recruiting
Cancer

Biological: BNT162b2 vaccine

administer an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Montefiore Medical Center
Bronx, New York, United States

Contacts

Balazs Halmos
718-405-8404
bahalmos@montefiore.org

Albert Einstein College of Medicine
NCT Number
Keywords
Covid-19
Booster