A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-Cov-2 Vaccines employed as Second Boost in Patients under current Rituximab Therapy and no humoral response after standard mRNA vaccinatio

Phase 1

Active, not recruiting

• Conditions: Vaccination against SARS-CoV-2 in patients with rituximab therapy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-002348-57-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Male and female subjects will be eligible for participation in this study if they:
1.Are =18 years on the day of screening
2.Have a chronic condition and have been treated with a B-cell depleting therapy (rituximab) within the last 12 months
3.Received mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) vaccine
4.Did not develop humoral immunity 4 weeks after second mRNA vaccination to SARS-CoV-2 (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)
5.A maximum of 6 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

Subjects will be excluded from participation in this study if they:
1.Have shown humoral response 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 study compounds
6.Urgent need for next rituximab application

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified