Immune Response Following COVID-19 Vaccination

• Conditions: IgM and IgG in Blood

• Registration Number: NCT04736524
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

Study Timeline

• Study Start: 2021-01-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-vaccination immune response	1 year	To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.

Trial Locations

Locations (1)

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