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Immune Response Following COVID-19 Vaccination

Immune Response Following COVID-19 Vaccination (IFVAC)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04736524
Acronym
IFVAC
Enrollment
500
Registered
2021-02-03
Start date
2021-01-15
Completion date
2022-03-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgM and IgG in Blood

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.

Interventions

OTHERRapid 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.

Sponsors

Texas Cardiac Arrhythmia Research Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Post-vaccination immune response1 yearTo assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.

Countries

United States

Contacts

Primary ContactAngel Mayedo
angel.mayedo@stdavids.com5125447254
Backup ContactBryan MacDonald
bryan.macdonald@stdavids.com5125447252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026