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NCT Number: NCT05597761

Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Adult Coronaviridae Infections Coronavirus Infections Immunocompromised Patients Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen, Aachen, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. BA.1-specific neutralizing antibody ID50 titers

    Time frame: 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

  2. Anti-Spike-1/2 IgG increase >33.8 BAU/ml

    Time frame: 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

  3. 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

    Time to decrease of Omicron BA.1-specific neutralizing antibody ID50 titers <20/ml after last mRNA vaccine in successfully vaccinated patients

  4. 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

    Time to anti-Spike-1/2 IgG decrease ≤33.8 BAU/ml after last mRNA vaccine in successfully vaccinated patients

Sponsors and collaborators

Lead sponsor

Oliver Cornely, MD

Other

Collaborators

  • German Federal Ministry of Education and Research
  • ZKS Köln

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2022
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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