Adult, COVID-19, Immunocompromised Patients
Conditions
Keywords
COVID-19, mRNA vaccination, Immunocompromised patients
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.
Interventions
None listed
Sponsors
ZKS Köln
German Federal Ministry of Education and Research
Oliver Cornely, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed