IgM and IgG in BloodIFVACNCT04736524
Immune Response Following COVID-19 Vaccination
An observational study of IgM and IgG in Blood, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- IgM and IgG in Blood
- What is being tested?
- Rapid antibody test
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- Child, Adult, Older adult
Study population: Individuals receiving COVID-19 vaccines
Who may be able to join
- Individuals that have received first dose of COVID-19 vaccine
Who cannot join
- Unwilling to provide informed consent
- Unwilling for the follow-up serological test during the 1-year enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, 78705
Mitra Mohanty, MD, 512-544-8198, mitra.mohanty@stdavids.com
Andrea Natale, MD
About this study
Official title: Immune Response Following COVID-19 Vaccination (IFVAC)
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.
Read the 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.
- Conditions
- IgM and IgG in Blood
- Being tested
- Rapid antibody test
- Medical subject headings
- Hyper-IgM Immunodeficiency Syndrome, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-vaccination immune response
To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start15 Jan 2021
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgM and IgG in BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, Principal investigator, Texas Cardiac Arrhythmia Research FoundationSanghamitra Mohanty, Study director, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736524
- Sponsor's protocol ID
- TCAI_IFVAC
- Acronym
- IFVAC
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be available for research purpose only by submitting a formal request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Following COVID-19 Vaccination (IFVAC)
- ClinicalTrials.gov ID
- NCT04736524
- Acronym / sponsor ID
- IFVAC / TCAI_IFVAC
- Conditions
- IgM and IgG in Blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals receiving COVID-19 vaccines
Key inclusion criteria (1 listed)
- Individuals that have received first dose of COVID-19 vaccine
Key exclusion criteria (2 listed)
- Unwilling to provide informed consent
- Unwilling for the follow-up serological test during the 1-year enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid antibody testSerial 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. | Other | – |
Primary outcome
Post-vaccination immune response
Time frame: 1 year
To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided. De-identified data will be available for research purpose only by submitting a formal request to the PI
Related trials for IgM and IgG in Blood
RecruitingObservational study
National Registry of Rare Kidney Diseases
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale principal investigator
Texas Cardiac Arrhythmia Research Foundation
Sanghamitra Mohanty study director
Texas Cardiac Arrhythmia Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IgM and IgG in Blood, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angel Mayedo (5125447254, angel.mayedo@stdavids.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-vaccination immune response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.