Immune Responses to COVID-19 Infection or Vaccination

NCT05379478 | Completed

• 1 other identifier: R2020-1002
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this observational cohort study is to characterize COVID-specific immune responses to SARS-CoV-2 exposure or COVID vaccination in a real-world setting. Participants will be asked to provide blood samples (either a normal venous blood draw, a few drops of blood obtained with a small finger-stick device, or both), as well as saliva or nasal swab sample at a series of visits. Subjects will receive results of the testing that is approved for routine clinical use (i.e., their AditxtScore), while residual samples from each visit will be stored for future testing. These efforts will support ongoing AditxtScore test development and enhance the effectiveness of its interpretation - aiding efforts to maximize benefits of clinical laboratory testing in the pandemic response.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Laboratory assessment of SARS-CoV-2 antibody profiles

  Antibody profiles consist of quantitative determination of IgG, IgM, and IgA levels to the SARs-CoV-2 spike protein (S), receptor binding domain (RBD), and nucleocapsid protein (NP) by flow cytometry. Also, Neutralizing Antibody (NAb) concentrations were determined with a novel flow cytometry based competitive inhibition assay for the measurement of total neutralizing antibodies to different variants of SARS-CoV-2.

  2 years

Study Arms (3)

Unvaccinated, COVID naive

Volunteers with no history of COVID-19 or vaccination. This is an observational study with no intervention

Diagnostic Test: Laboratory assessment of antibody profiles

Unvaccinated, Convalesced

Volunteers with a history of COVID-19 infection but no COVID-19 vaccination. This is an observational study with no intervention

Diagnostic Test: Laboratory assessment of antibody profiles

Vaccinated

Volunteers with a history of COVID-19 vaccination. This is an observational study with no intervention

Diagnostic Test: Laboratory assessment of antibody profiles

Interventions

Laboratory assessment of antibody profiles DIAGNOSTIC_TEST

Antibody profiles will be determined on submitted plasma samples

Unvaccinated, COVID naive; Unvaccinated, Convalesced; Vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community members with history of COVID vaccine, COVID exposure, or negative controls

You may qualify if:

• Willingness to participate
• years and older

You may not qualify if:

• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Aditxt, Inc.: lead

Study Sites (1)

Aditxt

Richmond, Virginia, 23219, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

up to 30ml of frozen plasma, serum, and isolated PBMCs will be retained for up to 5 years.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stephen Varvel, PhD

  Aditxt, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)