Immune Response Following COVID-19 Vaccination (IFVAC)

Texas Cardiac Arrhythmia Research Foundation

Status

Unknown

Conditions

IgM and IgG in Blood

Treatments

Other: Rapid antibody test

Study type

Observational

Funder types

Other

Identifiers

NCT04736524

TCAI_IFVAC

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

16 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria