COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients

NCT ID: NCT05054218

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-08-29

Brief Summary

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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

Detailed Description

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Conditions

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Covid19 SARS-CoV2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who receive 3rd dose of mRNA-1273 SARS-CoV-2 vaccine

Cancer patients who have already received their 1st and 2nd doses of mRNA-1273 SARS-CoV-2 vaccine will receive a 3rd dose of the vaccine. The volume of vaccine injected will be 0.5 mL, containing a 100-μg dose of mRNA-1273.

mRNA-1273

Intervention Type BIOLOGICAL

Participants will receive a 0.5 mL injection of the vaccine that contains a 100-μg dose of mRNA1273. The vaccine will be administered into the deltoid muscle.

Interventions

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mRNA-1273

Participants will receive a 0.5 mL injection of the vaccine that contains a 100-μg dose of mRNA1273. The vaccine will be administered into the deltoid muscle.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine study (a basic science study) MCC 21138 or who has completed the two mRNA-1273 vaccine series prior to March 31, 2021.
* Understands, agrees and is able to comply with the study procedures and provides written informed consent.
* Has no known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reactions to the vaccine or its excipients.
* Has not received more or less than 2 doses of mRNA-1273 vaccine

Exclusion Criteria

* Participants who will not return for the third vaccine dose
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Giuliano, PhD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

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Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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MCC-21536

Identifier Type: -

Identifier Source: org_study_id

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