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
- Tel. +49 (0)221 478 0
- Fax +49 (0)221 478 4095
- info@uk-koeln.de
(National) Coordinating Investigator
Univ.-Prof. Dr. med. Oliver A. Cornely
Project management
CTCC Project Management
- leading
Irini Papachristou
Infektiologie II
- internal coordination
- Tel. +49 (0)221 478-85523, -89757
- Fax +49 (0)221 478-85504
- research@uk-koeln.de
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
- Tel. +49 (0)221 478 88121
- Fax +49 (0)221 478 7983
- info@zks-koeln.de
Irina Moshkova
Database development
ZKS Köln
- Tel. +49 (0)221 478 88121
- Fax +49 (0)221 478 7983
- info@zks-koeln.de
Statistics
Institut für Medizinische Statistik und Bioinformatik (IMSB) Köln
- Tel. +49 (0)221 478 6501
- Fax +49 (0)221 478 6520
- imsie-webmaster@uni-koeln.de
Prof. Dr. rer. medic. , Dipl.-Math. Martin Hellmich