A-COV-V: Immunogenicity of COVID-19 Vaccinations in Autologous HSCT Recipients

Sponsor
University of Cologne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597761
Collaborator
ZKS Köln (Other), German Federal Ministry of Education and Research (Other)
100
1
26
3.8

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to the local COVID-19 vaccination standard, patients who underwent autologous HSCT will 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. Anti-SARS-CoV-2 immune parameters in successfully vaccinated patients will be followed-up for a total of 24-weeks.

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immunogenicity of Repeated COVID-19 Vaccination in Patients Post Autologous Stem Cell Transplantation
    Anticipated Study Start Date :
    Oct 31, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Omicron BA.1-specific neutralizing antibody titer [At the end of each vaccination cycle (each cycle is 28 days)]

      Time to Omicron BA.1-specific neutralizing antibody 50% inhibitory dilution (ID50) titers ≥20/ml in serum after repeated mRNA vaccinations.

    Secondary Outcome Measures

    1. Omicron BA.2-specific neutralizing titer [At the end of each vaccination cycle (each cycle is 28 days)]

      Time to Omicron BA.2-specific neutralizing ID50 titers ≥20/ml in serum after repeated mRNA vaccinations

    2. Time to anti-Spike-1/2 IgG increase [At the end of each vaccination cycle (each cycle is 28 days)]

      Time to anti-Spike-1/2 IgG increase >33.8 BAU/ml in serum after repeated mRNA vaccinations in patients post autologous HSCT

    3. Time to anti-RBD IgG increase [At the end of each vaccination cycle (each cycle is 28 days)]

      Time to anti-RBD IgG increase >7.1 BAU/ml in serum after repeated mRNA vaccinations in patients post autologous HSCT

    4. Time to anti-Spike-2 IgG increase [At the end of each vaccination cycle (each cycle is 28 days)]

      Time to anti-Spike-2 IgG increase >2x optical density in serum of the negative control

    5. Waning of BA.1 neutralizing antibodies [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

    6. Waning of BA.2 neutralizing antibodies [Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks]

      Time to decrease of Omicron BA.2-specific neutralizing antibody ID50 titers <20/ml after last mRNA vaccine in successfully vaccinated patients

    7. Waning of anti-Spike-1/2 IgG [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.

    8. Waning of anti-RBD IgG [Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks]

      Time to anti-RBD IgG decrease ≤7.1 BAU/ml after last mRNA vaccine in successfully vaccinated patients.

    9. Waning of anti-Spike-2 IgG [Every 28 days following last COVID-19 vaccination for a total duration of 24 weeks]

      Time to anti-Spike-2 IgG decrease ≤2x optical density of the negative control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    • 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.

    • 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.

    • 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.

    • Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding enrollment.

    • Planned use during the study of any investigational or non-registered product (vaccine or drug).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Cologne Cologne NRW Germany 50937

    Sponsors and Collaborators

    • University of Cologne
    • ZKS Köln
    • German Federal Ministry of Education and Research

    Investigators

    • Principal Investigator: Oliver A. Cornely, Prof., University Hospital of Cologne, Internal Medicine I

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oliver Cornely, MD, Investigator, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT05597761
    Other Study ID Numbers:
    • AUTO-COVID-VACC-4943
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Oliver Cornely, MD, Investigator, University of Cologne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 28, 2022