Profiling Spike Protein Antibody Response Post COVID-19 Booster

David Grant U.S. Air Force Medical Center

Status: Withdrawn

Conditions: Spike Protein IgG Antibody; COVID-19 Booster

Treatments: Diagnostic Test: Obtain antibody titers

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT05476822

FDG20210028H

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Adults who received a full course of COVID-19 vaccine and booster

Description:

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).

Treatment:

Diagnostic Test: Obtain antibody titers