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NCT05016622 Clinical Trial

Booster Dose Trial

Cancer Clinical Trial

Official title:
Safety and Efficacy of Booster Doses of BNT162b2 Vaccine in Immunocompromised Patients With a Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05016622
Other study ID # 2021-13204
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 10, 2021
Est. completion date December 2023

Study information
Verified date September 2023
Source Montefiore Medical Center
Contact Balazs Halmos
Phone 718-405-8404
Email bahalmos@montefiore.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)
Lead Sponsor Collaborator
Montefiore Medical Center Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
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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