Status:
COMPLETED
COVID-19 Vaccination of Immunodeficient Persons (COVAXID)
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Karolinska Institutet
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is designed as an open, non-randomized, phase IV cohort study in which the mRNA vaccine Comirnaty will be given in two doses. Analyses will be performed on blood and saliva, investigating hu...
Detailed Description
In this study with 450 patients with primary or secondary immunosuppressive disorders (patients with primary immunodeficiency, HIV infected patients, patients with allogenic stem cell transplantation/...
Eligibility Criteria
Inclusion
- 1\. Individuals ≥18 years old
- 2a. In the opinion of the investigator, individuals with immunosuppressive disease who meet one of the following criteria:
- Primary immunodeficiency
- Human immunodeficiency virus (HIV)-infection
- Allogeneic stem cell transplantation / Chimeric antigen receptor (CAR T cell) therapy
- Solid organ transplant
- Chronic lymphatic leukemia
- or
- 2b. In the opinion of the investigator, individuals without immunosuppressive disease or treatment without significant co-morbidity
- 3\. Provision of signed informed consent to participate in the study
Exclusion
- Previous or ongoing Coronavirus Disease-19 (COVID-19).
- Coagulation disorders, other conditions associated with prolonged bleeding time or anticoagulant treatments, which according to the investigator contraindicate intramuscular injection. Conditions which can be corrected with measures such as platelet concentrate treatments, coagulation factors or other measures for people responsible for anticoagulants are not exclusion criteria.
- Planned to receive another vaccine within 14 days before the first dose of the study vaccine, or during the period from the first dose of the study vaccine up to 14 days after the second dose of the study vaccine, and vaccination with another vaccine which in the investigator's opinion cannot be planned outside these time periods
- Pregnancy or breast feeding.
- Hypersensitivity to the active substance or to any of the excipients contained in the vaccine
- Individuals who cannot understand the informed consent.
- Individuals who for other reasons are considered by investigators as not suitable for inclusion
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2024
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT04780659
Start Date
February 23 2021
End Date
May 8 2024
Last Update
December 4 2025
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Huddinge, Sweden, 14186