Immune Response Following COVID-19 Vaccination (IFVAC)

February 2, 2021 updated by: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Immune Response Following COVID-19 Vaccination (IFVAC)

Few trials have reported the safety and efficacy of the COVID-19 vaccines. However, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin G (IgG) in blood at long-term follow-up after the vaccination. This study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The COVID-19 pandemic started in December 2019 and since then has spread globally claiming over 550, 000 deaths, >12 million infections and an economic toll in the trillions of dollars to date. The urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines.

Preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4).

However, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine.

Therefore, this study is designed to assess the presence of immunoglobulin (Ig) M and G at several time points after the first and the second dose of the vaccine.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac arrhythmia Institute, St. David's Hospital
        • Contact:
        • Principal Investigator:
          • Andrea Natale, MD
        • Sub-Investigator:
          • Mitra Mohanty, MD

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

12 years to 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals receiving COVID-19 vaccines

Description

Inclusion Criteria:

• Individuals that have received first dose of COVID-19 vaccine

Exclusion Criteria:

  • Unwilling to provide informed consent
  • Unwilling for the follow-up serological test during the 1-year enrollment

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-vaccination immune response
Time Frame: 1 year
To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.
1 year

Collaborators and Investigators

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

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Investigators

  • Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
  • Study Director: Sanghamitra Mohanty, Texas Cardiac Arrhythmia Research Foundation

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)

January 15, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAI_IFVAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

De-identified data will be available for research purpose only by submitting a formal request to the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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