Immunogenicity of COVID-19 Vaccination in Autologous HSCT or CAR-T Cells Recipients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597761
• Other study ID #: AUTO-COVID-VACC-4943
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Cologne
• Contact: Sybille Mellinghof, Dr.
• Phone: 0221 478 6494
• Email: sibylle.mellinghoff[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multicenter, prospective, non-interventional cohort study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in patients with B-cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who underwent autologous hematopoietic stem cell transplantation (HSCT) or who were treated with or chimeric-antigen-receptor-T-cells (CAR-T).

Description:

According to the COVID-19 vaccination standard, patients who underwent autologous HSCT or CAR-T cells receive between 3 to 8 anti-SARS-CoV-2 mRNA vaccination in 28-day intervals. The definitive number of vaccinations patients will receive depend on the individual neutralizing antibody response.

This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient 42 days (±3) post autologous HSCT or CAR-T cell treatment for B-cell non-Hodgkin lymphoma or Hodgkin lymphoma.

• Patient is 18 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/CAR-T cell treatment.

• Patient is treated at an institution that practices the standard-of-care COVID-19 vaccination

• Patient planned to be vaccinated against COVID-19 according to the hospital standard

• Written informed consent from patient has been obtained prior to any study related procedures

Exclusion criteria:

• Patient with confirmed SARS-CoV-2 infection between d0 and d42 after autologous HSCT or CAR-T cell treatment.

• Patient has a positive SARS-CoV-2 antigen test at visit d42

Related Conditions & MeSH terms

• COVID-19
• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Locations

Country	Name	City	State
Germany	Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV) Uniklinik der RWTH Aachen	Aachen	NRW
Germany	University Hospital of Cologne	Cologne	NRW
Germany	Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation	Essen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Oliver Cornely, MD	German Federal Ministry of Education and Research, ZKS Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Spike-IgG titers = 847 BAU/ml	Time to Anti-Spike-IgG titers = 847 BAU/ml after repeated mRNA vaccinations	At the end of each vaccination cycle (each cycle is 28 days)
Secondary	BA.1-specific neutralizing antibody ID50 titers	Time to Omicron BA.1-specific neutralizing antibody ID50 titers =20/ml after repeated mRNA vaccinations	At the end of each vaccination cycle (each cycle is 28 days)
Secondary	Anti-Spike-1/2 IgG increase >33.8 BAU/ml in serum	Time to anti-Spike-1/2 IgG increase >33.8 BAU/ml in serum after repeated mRNA vaccinations in patients post autologous HSCT	At the end of each vaccination cycle (each cycle is 28 days)
Secondary	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 CAR-T cell recipients.	At the end of each vaccination cycle (each cycle is 28 days)
Secondary	Anti-RBD IgG increase >7.1 BAU/ml	Time to anti-RBD IgG increase >7.1 BAU/ml after repeated mRNA vaccinations in patients post autologous HSCT	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Secondary	Anti-RBD IgG increase >7.1 BAU/ml	Time to anti-RBD IgG increase >7.1 BAU/ml after repeated mRNA vaccinations in CAR-T cell recipients	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Secondary	Anti-Spike-2 IgG increase >2x	Time to anti-Spike-2 IgG increase >2x optical density of the negative control	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Secondary	Decrease of Omicron BA.1-specific neutralizing antibody ID50 titers <20/ml	Time to decrease of Omicron BA.1-specific neutralizing antibody ID50 titers <20/ml after last mRNA vaccine in successfully vaccinated patients	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Secondary	Anti-RBD IgG decrease =7.1 BAU/ml	Time to anti-RBD IgG decrease =7.1 BAU/ml after last mRNA vaccine in successfully vaccinated patients	Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks
Secondary	Anti-Spike-2 IgG decrease =2x	Time to anti-Spike-2 IgG decrease =2x optical density of the negative control	At the end of each vaccination cycle (each cycle is 28 days)