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Clinical Trial 21536

Cancer Type: Multiple
Study Type: Prevention
NCT#: NCT05054218

Phase: N/A
Prinicipal Investigator: Anna Giuliano

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients

Summary

Investigators will evaluate the immunogenicity of a third dose of mRNA-1273 SARS-CoV-2 vaccine among cancer patients receiving the recommended third vaccine dose.

Objective

Primary Objectives - To evaluate immunogenicity among cancer patients to a third dose of 100 µg mRNA-1273 28 days and 6 months post-vaccination Secondary Objective - To evaluate the safety of a third dose of 100 µg mRNA-1273 administered to cancer patients up to 6 months post-third vaccine dose Exploratory Objective - In a study sub-population, to characterize the T cell response pre and post receipt of a third 100 µg mRNA-1273 vaccine dose

Treatments

Therapies

Medications

mRNA-1273 ()

Inclusion Criteria

  • Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine Study (MCC 21138) or who has completed the two mRNA-1273 vaccine series prior to March 30, 2021.
  • Understands, agrees, and is able to comply with the study procedures and provides written informed consent.

  • Exclusion Criteria

  • Is acutely ill or febrile 24 hours prior to or at the Day 1 visit. Fever is defined as a body temperature >38.0°C/> 100.4°F. Participants who meet this criterion may have the Day 1 visit rescheduled.
  • Has current treatment with investigational agents for either prophylaxis against COVID-19 or treatment of COVID-19 (eg, anti-SARS-CoV-2 monoclonal antibodies).
  • Has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically: Active symptoms of COVID-19 infection at the time of consent (e.g., fever, loss of taste and smell, etc.), Bleeding disorder that is considered a contraindication to IM injection or phlebotomy, Dermatologic conditions that could affect local solicited AR assessments, Known or suspected allergy or history of anaphylaxis, urticaria, or other significant AR to the vaccine or its excipients
  • Has received: Any non-study vaccine within 14 days before or after any dose of vaccine, More or less than 2 doses of mRNA-1273 vaccine

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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