Official Title
Immune Response Following COVID-19 Vaccination (IFVAC)
Brief Summary

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.

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.

Unknown status
IgM and IgG in Blood

Other: Rapid antibody test

Serial serology tests on day 21, 90, 180 and 365 following the first dose of the COVID-19 vaccine to detect the temporal trend of the IgM and IgG production in response to the vaccination.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 85 Years
Countries
United States
Locations

Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, United States

Investigator: Mitra Mohanty, MD
Contact: 512-544-8198
mitra.mohanty@stdavids.com

Investigator:

Contacts

Angel Mayedo
5125447254
angel.mayedo@stdavids.com

Bryan MacDonald
5125447252
bryan.macdonald@stdavids.com

Texas Cardiac Arrhythmia Research Foundation
NCT Number
MeSH Terms
Antibodies