NCT04944134

COVID-19 Antibody Levels After Vaccines

Vaccine Ig Levels in Nasal Mucosa as Measured by Nasal Epithelial Lining Fluid

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study will measure the levels of nasal mucosal Immunoglobulin A (IgA) and blood serum IgA up to one year after COVID vaccination, as well as examining what factors might affect antibody levels in the nose. This will be done through nasal epithelial lining fluid collection and standard venipuncture.

Detailed description

Based on data demonstrating that SARS-CoV-2 infections results in virus-specific nasal IgA levels even in patients with mild infections and no/low serum antibody titers, we hypothesize that COVID vaccinations result in robust nasal IgA levels. Since previous data indicate that SARS-CoV2 specific IgA were transiently present following community-acquired infections, we will follow vaccine-induced nasal IgA levels over time (6-12 months). Our specific aims are as following: Aim 1: Determine COVID vaccine specific immunoglobulin levels and immune mediator profiles in the nasal mucosa pre- and 14 days post second dose of COVID vaccine. Aim 2: Determine COVID specific immunoglobulin levels and immune mediator profiles at 3, 6, and 12 months following complete vaccination.

Conditions

• Vaccine Preventable Disease

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccination	Receipt of full COVID-19 vaccination

Timeline

• Start date: 2021-06-09
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-06-29
• Last updated: 2022-08-01

Locations

1 site across 1 country: United States