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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Vaccine Preventable Disease

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