Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients

September 11, 2024 updated by: Huntington Memorial Hospital

Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: an Analysis of Antibody Response Over Time

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Huntington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA who has completed the vaccination regimen

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SARS-CoV-2 IgG Titer Over Time
Time Frame: 8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion
Semi-quantitative SARS-CoV-2 IgG titer
8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of post-vaccine reactions
Time Frame: Within 3 days after vaccine injections
Subjective reporting of occurrence of post-vaccination reactions including anaphylactic reactions (such as difficulty breathing, swelling of face and throat, fast heartbeat, bad rash all over body, and dizziness and weakness); injection site pain; injection site swelling/hardness; injection site redness; tiredness; headache; muscle pain; chills; join pain; fever; nausea; feeling unwell; and/or swollen lymph nodes
Within 3 days after vaccine injections
Severity of post-vaccine reactions
Time Frame: Within 3 days after vaccine injections
Subjective reporting of severity of post-vaccine reactions (none, mild, moderate, or severe)
Within 3 days after vaccine injections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Memorial Hospital

Investigators

  • Principal Investigator: Kimberly Shriner, MD, Huntington Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00050032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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