COVID-19 Antibody Levels After Vaccines

NCT ID: NCT04944134

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-09

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Vaccine Preventable Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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COVID-19 Vaccination

Receipt of full COVID-19 vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Environmental Protection Agency (EPA)

FED

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilona Jaspers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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21-0371

Identifier Type: -

Identifier Source: org_study_id

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