Profiling Spike Protein Antibody Response Post COVID-19 Booster

Withdrawn

• Conditions: Spike Protein IgG Antibody; COVID-19 Booster
• Interventions: Diagnostic Test: Obtain antibody titers

• Registration Number: NCT05476822
• Lead Sponsor: David Grant U.S. Air Force Medical Center

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.

Study Timeline

• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-27
• Study Start: 2022-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults who received a full course of COVID-19 vaccine and booster	Obtain antibody titers	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).

Primary Outcome Measures

Name	Time	Method
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.
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.