Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC) (A-COV-V)

This multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in immunocompromised patients.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Adult; Immunocompromised Patients

Detailed Description

This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. for immunocompromised patients.

Additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations.

For this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen
    • Cologne, NRW, Germany, 50937
      • University Hospital of Cologne
    • Essen, NRW, Germany, 45147
      • Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Immunocompromised patients

Description

Inclusion criteria:

• Patient is vaccinated according to the recent version of the COVID-19 vaccination standard for immunocompromised patients.
• Patient is 18 years of age or older at enrollment.
• Written informed consent from patient has been obtained prior to any study related procedures

Exclusion criteria:

• Patient is not vaccinated according to the recent version of the COVID-19 vaccination standard. Patient has a positive SARS-CoV-2 antigen test at the first visit.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Spike-IgG titers	Time to an adequate immune response according to the recent version of the COVID-19 vaccination standard after repeated mRNA vaccinations	At the end of each vaccination cycle (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BA.1-specific neutralizing antibody ID50 titers	Time to Omicron BA.1-specific neutralizing antibody ID50 titers ≥20/ml after repeated mRNA vaccinations	At the end of each vaccination cycle (each cycle is 28 days)
Anti-Spike-1/2 IgG increase >33.8 BAU/ml	Time to anti-Spike-1/2 IgG increase >33.8 BAU/ml after repeated mRNA vaccinations in immunocompromised patients	At the end of each vaccination cycle (each cycle is 28 days)
Decrease of BA.1-specific neutralizing antibody ID50 titers	Time to decrease of Omicron BA.1-specific neutralizing antibody ID50 titers <20/ml after last mRNA vaccine in successfully vaccinated patients	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml	Time to anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml after last mRNA vaccine in successfully vaccinated patients	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks

Collaborators and Investigators

• Sponsor: Oliver Cornely, MD
• Collaborators: German Federal Ministry of Education and Research; ZKS Köln
• Investigators: Principal Investigator: Oliver A. Cornely, Prof., University Hospital of Cologne, Internal Medicine I

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; mRNA vaccination; Immunocompromised patients
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: AUTO-COVID-VACC-4943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No