NCT04736524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

February 1, 2021

Last Update Submit

February 2, 2021

Conditions

IgM and IgG in Blood

Outcome Measures

Primary Outcomes (1)

  • Post-vaccination immune response

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

    1 year

Interventions

Rapid antibody testOTHER

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.

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals receiving COVID-19 vaccines

You may qualify if:

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

You may not qualify if:

  • Unwilling to provide informed consent
  • Unwilling for the follow-up serological test during the 1-year enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Cardiac arrhythmia Institute, St. David's Hospital

Austin, Texas, 78705, United States

RECRUITING

MeSH Terms

Conditions

Hyper-IgM Immunodeficiency Syndrome, Type 1

Condition Hierarchy (Ancestors)

Hyper-IgM Immunodeficiency SyndromeDysgammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPrimary Immunodeficiency DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Andrea Natale

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

  • Sanghamitra Mohanty

    Texas Cardiac Arrhythmia Research Foundation

    STUDY DIRECTOR

Central Study Contacts

Angel Mayedo

CONTACT

5125447254angel.mayedo@stdavids.com

Bryan MacDonald

CONTACT

5125447252bryan.macdonald@stdavids.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Medical Director

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 3, 2021

Study Start

January 15, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

US(1)