A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination with an mRNA or Vector Vaccine in Patients under Immunosuppressive Therapy no or reduced Responds to Standard mRNA SARS-CoV-2 (Covid-19) Vaccinatio

Phase 1

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

• Registration Number: EUCTR2021-002693-10-AT
• Lead Sponsor: Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-19
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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:
1.Are =18 years on the day of screening
2.Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines.
3.Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination
4.A maximum of 12 months after second vaccination
5.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
6.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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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

Study & Design

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