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

NCT05597761 | Active Not Recruiting DMC

• 1 other identifier: AUTO-COVID-VACC-4943
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19; Adult; Immunocompromised Patients

Keywords

COVID-19; mRNA vaccination; Immunocompromised patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• BA.1-specific neutralizing antibody ID50 titers

  At the end of each vaccination cycle (each cycle is 28 days)

• Anti-Spike-1/2 IgG increase >33.8 BAU/ml

  At the end of each vaccination cycle (each cycle is 28 days)

• Decrease of BA.1-specific neutralizing antibody ID50 titers

  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

  Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Immunocompromised patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oliver Cornely, MD: lead
• ZKS Köln: collaborator
• German Federal Ministry of Education and Research: collaborator

Study Sites (3)

Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

• Cremer LM, Bethe U, Borchmann P, Di Cristanziano V, Gieselmann L, Grimm S, Hellmich M, Jakobs J, Nacov JA, Neuhann JM, Prattes J, Scheid C, Sprute R, Steger G, Stemler J, Mellinghoff SC, Cornely OA. Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC): Protocol for Multicenter Prospective Noninterventional Study. JMIR Res Protoc. 2025 May 26;14:e60675. doi: 10.2196/60675.

  PMID: 40418566 DERIVED

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

• Oliver A. Cornely, Prof.

  University Hospital of Cologne, Internal Medicine I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 28, 2022
• Study Start: May 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-11

Locations

DE (3)