Host Immune Response to Novel RNA COVID-19 Vaccination

NCT ID: NCT04784689

Last Updated: 2023-05-25

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-05-18

Brief Summary

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To determine the antibody response level in patients with cancer to the COVID-19 vaccination.

Detailed Description

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Conditions

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COVID-19 Vaccine Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective - Cancer Patients that have received COVID-19 Vaccination

COVID-19 Vaccine

Intervention Type BIOLOGICAL

COVID-19 Vaccine

Interventions

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COVID-19 Vaccine

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
3. Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
4. Able to provide informed consent
5. Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.

Exclusion Criteria

1. Previously documented COVID infection
2. Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
3. Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:

* Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
* Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\])
* Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
4. Pregnant or breastfeeding
5. Unable to comply with study related procedures as determined by the study team.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Kate Lathrop

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimpy Shah, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CTMS 21-0012

Identifier Type: -

Identifier Source: org_study_id

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