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Booster Dose Trial

NCT05016622 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-07-31

Study results available
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Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Balazs Halmos, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2022-04-20
Completion
2023-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05016622 on ClinicalTrials.gov