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

NCT ID: NCT05597761

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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COVID-19 Adult Immunocompromised Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZKS Köln

OTHER

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Oliver Cornely, MD

OTHER

Sponsor Role lead

Responsible Party

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Oliver Cornely, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Oliver A. Cornely, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne, Internal Medicine I

Locations

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

Aachen, North Rhine-Westphalia, Germany

Site Status

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 40418566 (View on PubMed)

Other Identifiers

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AUTO-COVID-VACC-4943

Identifier Type: -

Identifier Source: org_study_id

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