Recruiting

Immune Response

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT04736524

Conditions

IgM and IgG in Blood

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Rapid antibody test

Study Details

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.

Conditions

IgM and IgG in Blood

Study ID

NCT04736524

Start date

Jan 15, 2021

Status verified date

Feb, 2021

Completion date

Mar, 2022

Anticipated

Primary completion date

Mar, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Post-vaccination immune response [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Angel Mayedo

5125447254angel.mayedo@stdavids.com

Bryan MacDonald

5125447252bryan.macdonald@stdavids.com

Locations

Texas Cardiac arrhythmia Institute, St. David's Hospital

Recruiting

Austin, Texas, United States, 78705

Contacts

Mitra Mohanty, MD

512-544-8198mitra.mohanty@stdavids.com

Principal Investigator:

Andrea Natale, MD

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Feb 3, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2021-02-03.