Profiling Spike Protein Antibody Response Post COVID-19 Booster

March 22, 2023 updated by: Nolan Hudson, David Grant U.S. Air Force Medical Center
A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is primarily a descriptive study that will quantify with 95% confidence intervals the mean IgG antibodies remaining in vaccinated healthy participants three to nine months after their COVID booster. At specified intervals during this period, a titer will be performed on blood drawn from participants to quantify the IgG antibodies to the SARS-CoV-2 spike protein.

This evaluation will not be performed in a lab with CLIA certification and this study will not be used to seek an EUA from the FDA. The FDA and CLIA regulate diagnostic laboratory testing but do not regulate surveillance testing.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson & Johnson) and booster.

Description

Inclusion Criteria:

  • Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson & Johnson) and booster.

Exclusion Criteria:

  • Unvaccinated, partially vaccinated, or unable to provide proof of COVID vaccination
  • Unwilling or medically unable to have an initial or follow up blood sample drawn
  • Positive COVID test after receiving COVID booster
  • Current history of a bleeding disorder, cancer, or are immunocompromised
  • Received a COVID vaccine booster seven or more months ago

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults who received a full course of COVID-19 vaccine and booster
Adults at Travis Air Force Base who are Active Duty, DoD beneficiaries, and civilian employees who present with a vaccination card verifying they have received a full course of mRNA spike protein COVID vaccine (Moderna, Pfizer, or Johnson & Johnson) and booster will have antibody titers performed from blood drawn at time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).
Diagnostic test: Obtain antibody titers
Obtain blood samples for antibody titers at the time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster)
Time Frame: Within 2.5 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants at baseline (0-2.5 months post COVID booster).
Within 2.5 months post COVID booster
Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster
Time Frame: within 3 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 3 months post COVID booster.
within 3 months post COVID booster
Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster
Time Frame: within 6 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 6 months post COVID booster.
within 6 months post COVID booster
Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster
Time Frame: within 9 months post COVID booster
Quantify the mean IgG antibodies titers with 95% confidence interval in vaccinated healthy adult participants 9 months post COVID booster.
within 9 months post COVID booster

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Grant U.S. Air Force Medical Center

Investigators

  • Principal Investigator: Nolan R Hudson, MS, David Grant Medical Center, Travis AFB, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG20210028H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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