Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active AUTO-COVID-VACC NCT05597761

Immunogenicity of repeated COVID-19 vaccination in patients post autologous stem cell transplantation (AUTO-COVID-VACC)

Purpose / Objectives

Primary Outcome

To analyze the available data on neutralizing capacity against the Omicron variant after repeated mRNA vaccinations in patients post autologous hematopoietic stem cell transplant (HSCT) for B- non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL)

Secondary Outcomes

  • To analyze the available data on binding antibody response against the Omicron variant after repeated mRNA vaccinations in patients who underwent autologous HSCT.
  • To analyze the available data on waning of humoral immune response against the Omicron variant after last mRNA vaccine in successfully vaccinated patients.
  • To analyze reactogenicity data collected within this study.

Diagnosis

  • Hodgkin's Lymphoma
  • Non-Hodgkin Lymphome (English name missing)

Target population

Inclusion criteria

  • Patient 42 days (±3) post autologous HSCT for B-cell non-Hodgkin lymphoma or Hodgkin lymphoma.
  • Patient is 30 years of age or older at enrollment.
  • Patients are eligible for study inclusion with or without confirmed SARS-CoV-2 infection prior to autologous HSCT.
  • Patient is treated at an institution that practices the standard-of-care COVID-19 vaccination (Appendix 1).
  • Patient has received 3 or more vaccinations with an anti-SARS-CoV-2 mRNA vaccine prior to autologous HSCT.
  • Patient planned to be vaccinated against COVID-19 according to the hospital standard (Appendix 1).
  • Written informed consent from patient has been obtained prior to any study related procedures (Section 12.3).

Exclusion criteria

  • Patient with confirmed SARS-CoV-2 infection between d0 and d42 after autologous HSCT.
  • Patient has a positive SARS-CoV-2 antigen test at visit d42.
  • Patient has received less than 3 vaccinations with an anti-SARS-CoV-2 mRNA vaccine prior to autologous HSCT.

Study design

  • Multicenter
  • Prospective
  • Cohort

Intervention

keine, da nicht-interventionelle Studie

Documents (password protected)

Responsibilities in overall study

Sponsor

Universitätsklinikum Köln

(National) Coordinating Investigator

Univ.-Prof. Dr. med. Oliver A. Cornely

Project management

CTCC Project Management

  • leading

Irini Papachristou

Infektiologie II

Dr. rer. medic. Sarah Grimm
Julia Jakobs

ZKS Köln - Projekt Management

  • CPA

Beatrix Burmeister

Monitoring

ZKS Köln Monitoring

Dr. rer. nat. Ioannis Kienes

Data management

ZKS Köln

Irina Moshkova

Database development

ZKS Köln

Statistics

Institut für Medizinische Statistik und Bioinformatik (IMSB) Köln

Prof. Dr. rer. medic. , Dipl.-Math. Martin Hellmich