COVID-19 Booster, Spike Protein IgG Antibody
Conditions
Brief summary
A descriptive study that will quantify the mean IgG antibodies remaining in vaccinated healthy participants after their COVID booster.
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.
Interventions
DIAGNOSTIC_TESTObtain 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).
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of IgG antibody for SARS-CoV-2 spike protein at baseline (0-2.5 months post booster) | 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). |
| Level of IgG antibody for SARS-CoV-2 spike protein 3 months post COVID booster | 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. |
| Level of IgG antibody for SARS-CoV-2 spike protein 6 months post COVID booster | 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. |
| Level of IgG antibody for SARS-CoV-2 spike protein 9 months post COVID booster | 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. |
Outcome results
None listed