Status:
COMPLETED
Immunocompromised Swiss Cohorts Based Trial Platform
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Science Foundation
ModernaTX, Inc.
Conditions:
Immunocompromised Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study \[SHCS\] and Swiss Transplant Cohort Study \[STCS\]) to...
Detailed Description
The aim of this study is to set up a flexible trial platform using two existing national cohorts of immunocompromised patients (i.e. Swiss HIV Cohort Study \[SHCS\] and Swiss Transplant Cohort Study \...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All patients registered with informed consent from participating cohorts aged ≥18 years
- Additional consent for participation in the specific sub-protocol trial
- Inclusion criteria for pilot trial:
- All patients with either a chronic HIV infection or recipients of solid organs registered with informed consent from the SHCS and STCS cohorts aged ≥18 years
- Patients with solid organ transplantation of lungs or kidneys at least one month post-transplantation with a prednisone dose of 20mg or less.
- Covid-19 vaccination recommended by treating physician
- Inclusion criteria for 2. sub protocol (observational study):
- Third covid-19 vaccination recommended by treating physician and administered in the frame of clinical routine
- Inclusion criteria for 3. substudy.
- \- Patients receiving a new bivalent (Wuhan/Omicron BA.1) mRNA SARS-CoV-2 vaccine in the frame of clinical routine, according to the treating physician
- Exclusion criteria:
- Acute symptomatic SARS-CoV-2 infection, influenza or other acute respiratory tract infection
- Known allergy or contra-indications for vaccines or any vaccine components
- Any emergency condition requiring immediate hospitalization for any condition
- Patients with previous PCR documented SARS-CoV-2 infection and, or documented antibodies less than 3 months prior to screening visit (day 0)
- Exclusion criteria for pilot trial:
- Pregnancy
- Acute symptomatic SARS-CoV-2 infection, influenza or other acute respiratory tract infection
- Known allergy or contra-indications for vaccines or any vaccine components
- Any emergency condition requiring immediate hospitalization for any condition
- Patients with previous PCR documented SARS-CoV-2 infection and, or documented antibodies less than 3 months prior to randomisation
- Patients with solid organ transplantation (lung or kidney) with the following conditions:
- Solid organ transplant recipients less than one month post-transplantation
- Solid organ transplant recipients with the use of T-cell/B-cell depleting agents in the last 3 months (i. e induction treatment in standard risk or high-risk immunological situation or rejection treatment).
- Solid organ transplant recipients with the need of pulse corticosteroids (\>100mg prednisone or equivalent) in the last 1 month or who have received ATG or rituximab in the last 6 months
- Solid organ transplant recipients with the need of any kind of chemotherapy treatment
Exclusion
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2023
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT04805125
Start Date
April 19 2021
End Date
September 23 2023
Last Update
January 25 2024
Active Locations (4)
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1
University Hospital Basel
Basel, Switzerland, 4031
2
University Hospital Bern
Bern, Switzerland, 3010
3
University Hospital Lausanne CHUV
Lausanne, Switzerland, 1011
4
University Hospital Zurich
Zurich, Switzerland, 8091