NCT05476822

Profiling Spike Protein Antibody Response Post COVID-19 Booster

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: David Grant U.S. Air Force Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Booster
• Spike Protein IgG Antibody

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-07-27
• Last updated: 2023-03-24