COVID-19NCT05597761
Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
An observational study of COVID-19 and Adult, run by Oliver Cornely, MD at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Adult, Immunocompromised Patients
- How many people
- 49 participants
- Where
- 3 sitesGermany
- Study dates
- 15 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Immunocompromised patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation
Essen, North Rhine-Westphalia, 45147
About this study
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.
Read the 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.
- Conditions
- COVID-19, Adult, Immunocompromised Patients
- Keywords
- COVID-19, mRNA vaccination, Immunocompromised patients
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of each vaccination cycle (each cycle is 28 days)
Secondary outcomes (4)
BA.1-specific neutralizing antibody ID50 titers
Time to Omicron BA.1-specific neutralizing antibody ID50 titers ≥20/ml after repeated mRNA vaccinations
Measured: 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
Measured: 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
Measured: 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
Measured: Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start15 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oliver Cornely, MD
- Sponsor type
- University, hospital or other
- Collaborators
- ZKS Köln, German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A. Cornely, Prof., Principal investigator, University Hospital of Cologne, Internal Medicine I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597761
- Sponsor's protocol ID
- AUTO-COVID-VACC-4943
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40418566
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
- ClinicalTrials.gov ID
- NCT05597761
- Acronym / sponsor ID
- AUTO-COVID-VACC-4943
- Conditions
- COVID-19, Adult, Immunocompromised Patients
- Keywords
- COVID-19, mRNA vaccination, Immunocompromised patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Oliver Cornely, MDUniversity, hospital or other
- Collaborators
- ZKS Köln, German Federal Ministry of Education and Research
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Immunocompromised patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-Spike-IgG titers
Time frame: 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
4 secondary outcomes
BA.1-specific neutralizing antibody ID50 titers
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 frame: At the end of each vaccination cycle (each cycle is 28 days)
Decrease of BA.1-specific neutralizing antibody ID50 titers
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 frame: Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 40418566Cremer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver A. Cornely, Prof. principal investigator
University Hospital of Cologne, Internal Medicine I
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Adult, run by Oliver Cornely, MD at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Spike-IgG titers (time frame: At the end of each vaccination cycle (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.