COVID-19 Antibody Levels After Vaccines

University of North Carolina (UNC)

Status: Completed

Conditions: Vaccine Preventable Disease

Treatments: Biological: COVID-19 Vaccination

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04944134

21-0371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals at least 18 years of age who have or plan to receive a COVID-19 vaccination
• Able to be seen at UNC Chapel Hill's main campus up to 5 times in the next year

Exclusion criteria

• Individuals unwilling to give consent