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NCT04944134 Clinical Trial

COVID-19 Antibody Levels After Vaccines

Vaccine Preventable Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04944134
Other study ID # 21-0371
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 9, 2021
Est. completion date April 1, 2022

Study information
Verified date May 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• COVID-19 Vaccination
Receipt of full COVID-19 vaccination

Locations
Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Environmental Protection Agency (EPA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nasal Mucosal COVID-specific IgA Level of COVID-specific antibodies in the nasal mucosa Up to 14 months
Primary Serum COVID-specific IgA Level of COVID-specific antibodies in the blood serum Up to 14 months
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