Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid antibody test | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-vaccination immune response | To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination. | 1 year |
Not provided
Not provided
Inclusion Criteria:
• Individuals that have received first dose of COVID-19 vaccine
Exclusion Criteria:
Not provided
Not provided
Not provided
Individuals receiving COVID-19 vaccines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angel Mayedo | Contact | 5125447254 | angel.mayedo@stdavids.com | |
| Bryan MacDonald | Contact | 5125447252 | bryan.macdonald@stdavids.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Sanghamitra Mohanty | Texas Cardiac Arrhythmia Research Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac arrhythmia Institute, St. David's Hospital | Recruiting | Austin | Texas | 78705 | United States |
De-identified data will be available for research purpose only by submitting a formal request to the PI
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053307 | Hyper-IgM Immunodeficiency Syndrome, Type 1 |
| ID | Term |
|---|---|
| D053306 | Hyper-IgM Immunodeficiency Syndrome |
| D004406 | Dysgammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000081207 | Primary Immunodeficiency Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |