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

Active, not recruiting

• Conditions: COVID-19; Adult; Immunocompromised Patients

• Registration Number: NCT05597761
• Lead Sponsor: Oliver Cornely, MD

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-28
• Study Start: 2023-05-15
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen; 🇩🇪 Aachen, NRW, Germany

University Hospital of Cologne; 🇩🇪 Cologne, NRW, Germany

Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation; 🇩🇪 Essen, NRW, Germany