IFVAC: Immune Response Following COVID-19 Vaccination

• Sponsor: Texas Cardiac Arrhythmia Research Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04736524
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 37.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IgM and IgG in Blood	Other: Rapid antibody test

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immune Response Following COVID-19 Vaccination (IFVAC)
• Actual Study Start Date: Jan 15, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Outcome Measures

Primary Outcome Measures

1. Post-vaccination immune response [1 year]

   To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 85 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Cardiac arrhythmia Institute, St. David's Hospital	Austin	Texas	United States	78705

Sponsors and Collaborators

• Texas Cardiac Arrhythmia Research Foundation

Investigators

• Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
• Study Director: Sanghamitra Mohanty, Texas Cardiac Arrhythmia Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
• ClinicalTrials.gov Identifier: NCT04736524
• Other Study ID Numbers: TCAI_IFVAC
• First Posted: Feb 3, 2021
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Antibodies

Study Results

No Results Posted as of Feb 3, 2021