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COVID-19 Antibody Levels After Vaccines

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04944134
Enrollment
71
Registered
2021-06-29
Start date
2021-06-09
Completion date
2022-04-01
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccine Preventable Disease

Keywords

COVID-19, Vaccination

Brief 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.

Interventions

BIOLOGICALCOVID-19 Vaccination

Receipt of full COVID-19 vaccination

Sponsors

Environmental Protection Agency (EPA)
CollaboratorFED
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Nasal Mucosal COVID-specific IgAUp to 14 monthsLevel of COVID-specific antibodies in the nasal mucosa
Serum COVID-specific IgAUp to 14 monthsLevel of COVID-specific antibodies in the blood serum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026