COVID-19 Antibody Levels After Vaccines

Completed

• Conditions: Vaccine Preventable Disease

• Registration Number: NCT04944134
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2021-06-09
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-29
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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Exclusion Criteria

• Individuals unwilling to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum COVID-specific IgA	Up to 14 months	Level of COVID-specific antibodies in the blood serum
Nasal Mucosal COVID-specific IgA	Up to 14 months	Level of COVID-specific antibodies in the nasal mucosa

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States