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Immunogenicity of COVID-19 vaccination in immunocompromised patients (Auto-COVID-VACC): Protocol for a multicenter prospective non-interventional study
Louise Marie Cremer;
Ullrich Bethe;
Peter Borchmann;
Veronica Di Cristanziano;
Lutz Gieselmann;
Sarah Grimm;
Martin Hellmich;
Julia Jeck;
Julia A. Nacov;
Julia Neuhann;
Juergen Prattes;
Christoph Scheid;
Rosanne Sprute;
Gertrud Steger;
Jannik Stemler;
Sibylle C. Mellinghoff;
Oliver A. Cornely
ABSTRACT
Background:
Despite availability of vaccines, immunocompromised patients are still at high risk for severe COVID-19. While vaccination schedules for the general population have been defined, achieving immunogenicity in immunocompromised patients remains a challenge.
Objective:
The primary objective is to analyze anti-spike-IgG titers after repeated mRNA vaccinations in immunocompromised patients. Further objectives are to analyze data on humoral immune responses and to evaluate data on cellular immune response.
Methods:
This multicenter, prospective, non-interventional study aims to determine immunogenicity and reactogenicity of an implemented standard-of-care COVID-19 vaccination strategy in immunocompromised patients. A total of 100 patients will be recruited at three study sites.
Additional blood samples will be drawn at each scheduled outpatient visit. 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 standard care.
Results:
As of August 2024, the study has enrolled 32 patients. The recruitment phase is still ongoing.
Conclusions:
Results will be used to optimize vaccination and booster schedules for immunocompromised patients and to increase rates of protection against severe SARS-CoV-2 infections. Further, results may identify risk and treatment factors, which lead to low immune responses in patients vaccinated against COVID-19, as well as the impact of repeated vaccination on B and T cell responses. Clinical Trial: ClinicalTrials.gov NCT05597761; https://clinicaltrials.gov/study/NCT05597761?term=Auto-COVID-VACC&rank=1
Citation
Please cite as:
Cremer LM, Bethe U, Borchmann P, Di Cristanziano V, Gieselmann L, Grimm S, Hellmich M, Jeck J, Nacov JA, Neuhann J, 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