COVID-19 Antibody Levels After Vaccines

July 28, 2022 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals vaccinated against COVID-19

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Mucosal COVID-specific IgA
Time Frame: Up to 14 months
Level of COVID-specific antibodies in the nasal mucosa
Up to 14 months
Serum COVID-specific IgA
Time Frame: Up to 14 months
Level of COVID-specific antibodies in the blood serum
Up to 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Environmental Protection Agency (EPA)

Investigators

  • Principal Investigator: Ilona Jaspers, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-0371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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