An observational study in COVID-19, Adult and Immunocompromised Patients, sponsored by Oliver Cornely, MD. Active, not recruiting at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Oliver Cornely, MD · Observational
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 49 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Oliver Cornely, MD is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Immunocompromised patients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: At the end of each vaccination cycle (each cycle is 28 days)
BA.1-specific neutralizing antibody ID50 titers
Time to Omicron BA.1-specific neutralizing antibody ID50 titers ≥20/ml after repeated mRNA vaccinations
Time frame: At the end of each vaccination cycle (each cycle is 28 days)
Anti-Spike-1/2 IgG increase >33.8 BAU/ml
Time to anti-Spike-1/2 IgG increase \>33.8 BAU/ml after repeated mRNA vaccinations in immunocompromised patients
Time frame: 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
Time frame: 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
Time frame: Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Sep 2025, 28 months after the start.
Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 28 months is above that.
Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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