Booster Dose Trial

Sponsor

Montefiore Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05016622

Collaborator

Albert Einstein College of Medicine (Other)

100

Enrollment

Location

Arm

36.7

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Biological: BNT162b2 vaccine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 10, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Booster dose	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.

Arm

Intervention/Treatment

Experimental: Booster dose

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.

Outcome Measures

Primary Outcome Measures

Rates of seroconversion for SARS-CoV-2 spike antibody [4 weeks after booster dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center
Albert Einstein College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT05016622

Other Study ID Numbers:

2021-13204

First Posted:

Aug 23, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Montefiore Medical Center

COVID-19

Booster

Study Results

No Results Posted as of Dec 17, 2021