NCT04944134

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

June 25, 2021

Last Update Submit

July 28, 2022

Conditions

Vaccine Preventable Disease

Keywords

COVID-19Vaccination

Outcome Measures

Primary Outcomes (2)

  • Nasal Mucosal COVID-specific IgA

    Level of COVID-specific antibodies in the nasal mucosa

    Up to 14 months

  • Serum COVID-specific IgA

    Level of COVID-specific antibodies in the blood serum

    Up to 14 months

Interventions

COVID-19 VaccinationBIOLOGICAL

Receipt of full COVID-19 vaccination

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals vaccinated against COVID-19

You may qualify if:

  • 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

You may not qualify if:

  • Individuals unwilling to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Vaccine-Preventable DiseasesCOVID-19

Interventions

heterologous prime boost COVID-19 vaccination

Condition Hierarchy (Ancestors)

InfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ilona Jaspers, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

June 29, 2021

Study Start

June 9, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

August 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)