NCT04736524

Immune Response Following COVID-19 Vaccination

Immune Response Following COVID-19 Vaccination (IFVAC)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Texas Cardiac Arrhythmia Research Foundation · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: —

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.

Conditions

• IgM and IgG in Blood

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-02-03
• Last updated: 2021-02-03

Locations

1 site across 1 country: United States