Profiling Spike Protein Antibody Response Post COVID-19 Booster

Study Overview
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Brief Summary
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A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.

Detailed Description
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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.

Official Title
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Profiling Spike Protein Antibody Response Post COVID-19 Booster

Conditions
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COVID-19 Booster, Spike Protein IgG Antibody

Intervention / Treatment
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* Diagnostic Test: Obtain antibody titers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults who received a full course of COVID-19 vaccine and booster<br>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<br>* Obtain blood samples for antibody titers at the time of enrollment, at three months, six months and nine months post vaccine booster (+/- ten days).<br>|

What is the study measuring?
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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) | 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 | 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 | 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 | 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 |