Booster Dose Trial

NCT05016622 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: 2021-132042UG1CA189859-06IRV-BC0004-223P30CA013330-49S3
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

COVID-19; Booster

Outcome Measures

Primary Outcomes (2)

• Rate of Seroconversion for SARS-CoV-2 Spike Antibody Among Patients Who Were Seronegative After Primary Series of COVID-19 Vaccinations

  Rate will be determined as the percentage of patients demonstrating booster-induced seroconversion, as evidenced by anti-Spike antibody testing, who were seronegative after the primary series of FDA authorized COVID-19 vaccinations.

  4 weeks after administration of 1st booster dose

• Percentage of Patients Who Were 'Responders' After 2nd Booster Dose

  A patient was classified as a responder if they either (1) had positive anti-S antibody at 4 weeks if seronegative at baseline (following 1st booster dose) or (2) if they achieved a titer of \>1000 AU/mL at 4 weeks if they were sero-low at baseline (following 1st booster dose)

  4 weeks after administration of 2nd booster dose

Secondary Outcomes (27)

• Positive Anti-Spike Antibody (IgG) Titer

  4 weeks after administration of 1st booster dose

• Spike Antibody Titer

  4 weeks after administration of 1st booster dose

• Change in Anti-Spike Antibody Titer for Patients With Hematologic Malignancies

  Baseline to 4 weeks after administration of 1st booster dose

• Change in Anti-Spike Antibody Titer for Patients With Solid Tumor Malignancies

  Baseline to 4 weeks after administration of 1st booster dose

• Change in Anti-Spike Antibody Titer Among Patients With Hematologic Malignancy by Type

  Baseline to 4 weeks after administration of 1st booster dose

Study Arms (1)

Booster dose

EXPERIMENTAL

Biological: BNT162b2 vaccine

Interventions

BNT162b2 vaccine BIOLOGICAL

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.

Booster dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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 study enrollment

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Albert Einstein College of Medicine: collaborator
• National Cancer Institute (NCI): collaborator
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Thakkar A, Pradhan K, Duva B, Carreno JM, Sahu S, Thiruthuvanathan V, Campbell S, Gallego S, Bhagat TD, Rivera J, Choudhary G, Olea R, Sabalza M, Shapiro LC, Lee M, Quinn R, Mantzaris I, Chu E, Will B, Pirofski LA, Krammer F, Verma A, Halmos B. Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial. Elife. 2023 Mar 28;12:e83694. doi: 10.7554/eLife.83694.

  PMID: 36975207 DERIVED

MeSH Terms

Conditions

Neoplasms; COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Dr. Balazs Halmos
• Organization: Montefiore Medical Center

bahalmos@montefiore.org

718-405-8404

Study Officials

• Balazs Halmos, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: August 10, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 21, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)