Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

NCT ID: NCT04922944

Last Updated: 2024-09-19

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

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2022-03-01

Brief Summary

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This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.

Detailed Description

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As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.

This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.

Conditions

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Covid19 Vaccine Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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COVID-19 vaccine

Two-dose COVID-19 vaccine

Intervention Type DRUG

Other Intervention Names

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Pfizer-BioNTech COVID-19 vaccine Moderna COVID-19 vaccine

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent for study
* Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
* Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
* Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
* Able to read English, sign consent form and complete on-line surveys

Exclusion Criteria

* Huntington Hospital employees on leave of absence
* Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huntington Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Shriner, MD

Role: PRINCIPAL_INVESTIGATOR

Huntington Hospital

Locations

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Huntington Hospital

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00050032

Identifier Type: -

Identifier Source: org_study_id

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