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Clinical Trials/EUCTR2021-002693-10-AT
EUCTR2021-002693-10-AT
Active, not recruiting
Phase 1

A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination in Immunocompromised Patients with Inadequate Humoral Response after Primary mRNA SARS-CoV-2 (Covid-19) Vaccination - VAC3 SARS-CoV-2 seroconversion study

Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology0 sites300 target enrollmentMay 19, 2021
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ConditionsVaccination against SARS-CoV-2 in patients with immunosuppressive therapy or immunodeficienciesTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsComirnaty concentrate for dispersion for injectionCovid-19 Vaccine Moderna dispersion for injectionVaxzevria

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Vaccination against SARS-CoV-2 in patients with immunosuppressive therapy or immunodeficiencies
Sponsor
Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology
Enrollment
300
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 19, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology

Eligibility Criteria

Inclusion Criteria

  • •a) Male and female patients will be eligible for participation in this study if they:
  • •1\.Are \=18 years on the day of screening
  • •2\.Being immunocompromised (either primary or secondary immunodeficiency or been treated with immunosuppressive therapy within the last 12 months
  • •Immunosuppressive therapies include glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins and other treatments like interferons and TNF binding proteins and exclude patients under B cell depleting therapy (like Rituximab, Ocrelicumab, Ofatumumab, Epratuzumab or Obinutuzumab)
  • •3\.Received two doses of SARS\-CoV\-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines.
  • •4\.Did develop \< 1500 U/ml of SARS\-CoV\-2 antibodies 4 weeks after second mRNA vaccination (analyzed during the study Characterization of immune responsiveness after mRNA SARS\-CoV\-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK\-Nr. 1073/2021, EudraCT Nr. 2021\-000291\-11, or external routine evaluation of humoral response)
  • •5\.A maximum of 12 months after second vaccination
  • •6\.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
  • •7\.If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
  • •b) Male and female healthy controls will be eligible for participation in this study if they:

Exclusion Criteria

  • •Subjects will be excluded from participation in this study if they:
  • •1\.Have shown humoral response (\> 1500 U/ml) to the SARS\-CoV\-2 vaccination
  • •2\.Had grade 3 adverse effects from the mRNA vaccination reported
  • •3\.Pregnancy and breast feeding
  • •4\.Signs of SARS\-CoV\-2 infection (including previous positive PCR testing)
  • •5\.Any other contraindication to any of the vaccine compounds
  • •6\.For healthy controls: diagnosis of chronic inflammatory condition including primary or secondary immunodeficiency or ever receiving immunosuppressing therapy as stated above

Outcomes

Primary Outcomes

Not specified

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