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TerminatedPhase 2NCT05016622
Official study title

Booster Dose Trial

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedBNT162b2 vaccine

The study team can explain what participation involves.

Who it may be forCancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 31, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Montefiore Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Phase 2
Sponsor
Montefiore Medical Center
Interventions being studied
Biological: BNT162b2 vaccine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • (Cohort 1):
  • Above the age of 18
  • Meet one of the sub-criteria below:
  • Meet the CDC definition for immunocompromised status for cancer patients, i.e patients receiving active treatment for solid tumor or hematologic malignancy OR
  • Be a recipient of stem cell transplant or CAR-T cell therapy in the last 2 years OR
  • Have a negative SARS-CoV-2 spike IgG despite standard vaccination series, irrespective of active/inactive cancer status, on observation, or active therapy.
  • Underwent an in-person encounter at a study facility during the study period
  • Have received the second of the mRNA-based vaccines BNT162b2 and mRNA-1273 (Pfizer/BioNTech or Moderna, respectively) or one dose of the adenoviral Ad26CoV2.S (Johnson \& Johnson) vaccine at least 28 days before the booster dose.
Reasons someone may not be able to joinExclusion criteria
  • (Cohort 1):
  • 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 Inclusion Criteria (Cohort 2):
  • Above the age of 18
  • Have a diagnosis of prior or active malignancy, either hematological or solid tumor
  • Have a negative or low-level SARS-CoV-2 spike IgG after 14 days of booster vaccination series irrespective of active/inactive cancer status, on observation, or active therapy.
  • Have received an FDA-authorized booster dose of mRNA (BNT162b2 and mRNA-1273) vaccine at least 28 days before study enrollment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Montefiore Medical CenterThe Bronx, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 31, 2024. Always confirm current availability with the study team.

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