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| Name | Class |
|---|---|
| ZKS Köln | OTHER |
| German Federal Ministry of Education and Research | OTHER_GOV |
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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.
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.
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| 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) |
| 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 |
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Inclusion criteria:
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.
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Immunocompromised patients
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| Name | Affiliation | Role |
|---|---|---|
| Oliver A. Cornely, Prof. | University Hospital of Cologne, Internal Medicine I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40418566 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| University Hospital of Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation | Essen | North Rhine-Westphalia | 45147 | Germany |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |