Clinical trial NCT05597761: Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
Official title: Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Adult
Immunocompromised Patients
Keywords: COVID-19
mRNA vaccination
Immunocompromised patients
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: ZKS Köln
name: German Federal Ministry of Education and Research
First posted: 2022-10-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-Spike-IgG titers
timeFrame: At the end of each vaccination cycle (each cycle is 28 days)
Secondary outcomes:
measure: BA.1-specific neutralizing antibody ID50 titers
timeFrame: At the end of each vaccination cycle (each cycle is 28 days)
measure: Anti-Spike-1/2 IgG increase >33.8 BAU/ml
timeFrame: At the end of each vaccination cycle (each cycle is 28 days)
measure: Decrease of BA.1-specific neutralizing antibody ID50 titers
timeFrame: Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
measure: Anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml
timeFrame: Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen
state: NRW
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
city: Essen
country: Germany
facility: Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation
state: NRW
Study officials:
affiliation: University Hospital of Cologne, Internal Medicine I
name: Oliver A. Cornely, Prof.
role: PRINCIPAL_INVESTIGATOR
References: