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OpenTrials
Completed

NCT Number: NCT04944134

COVID-19 Antibody Levels After Vaccines

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.

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Key information

Conditions

Vaccine Preventable Disease COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine-Preventable Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 Vaccination

Biological

Receipt of full COVID-19 vaccination

Primary outcomes

  1. Nasal Mucosal COVID-specific IgA

    Time frame: Up to 14 months

    Level of COVID-specific antibodies in the nasal mucosa

  2. Serum COVID-specific IgA

    Time frame: Up to 14 months

    Level of COVID-specific antibodies in the blood serum

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Environmental Protection Agency (EPA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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