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 humoral and cellular vaccine responses. Occurence of local or systemic reactogenicity will be evaluated, as well as adverse events. The study will include persons with primary or secondary immunosuppressive disorders, as well as immunocompetent persons, with the aim of investigating if the immune responses after given Comirnaty mRNA vaccine against COVID-19.
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/CAR T cell treated, solid organ transplanted, and patients with chronic lymphatic leukemia) from Karolinska University Hospital, and healthy controls of 90 individuals for comparison, we will investigate the safety and the immune responses after mRNA vaccination with Comirnaty after two doses, under 6 months of time for each participant. The study is In collaboration with research groups at Karolinska Institutet and SciLifeLab, with planned in-depth detailed analyses of antibody responses as well as cellular responses. The study has obtained permission from Swedish Medical Agency and Swedish Ethical Review Authority.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
539
Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.
Karolinska University Hospital
Stockholm, Huddinge, Sweden
Assessment of Seroconversion, Defined as Development of Immunoglobulin G (IgG) Antibodies Against Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) After Vaccination of 2 Doses in Seronegative Individuals.
Proportion (95% confidence interval, CI) seroconverting to positive response to SARS-CoV-2 IgG serology test after two doses of vaccine, measured 2 weeks after second dose of vaccine.
Time frame: 2 weeks after second dose of vaccine.
Assessment of Any Adverse Events (AE) of the Given Vaccine.
Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 1)
Time frame: Duration of 0-14 days after the first vaccine dose.
Assessment of Any Adverse Events (AE) of the Given Vaccine.
Proportion (95% CI) who experience adverse events, with AE/SAE/SUSAR (after dose 2)
Time frame: Duration of 0-14 days after the second vaccine dose.
Frequency Who Experience Local and Systemic Reactions
Number and proportion (95% CI) who experience local and systemic reactions (after dose 1)
Time frame: After the first vaccin dose
Frequency Who Experience Local and Systemic Reactions
Number and proportion (95% CI) who experience local and systemic reactions (after dose 2)
Time frame: After the second vaccin dose
Frequency of SARS-CoV-2 Infection Documented by PCR Test.
Proportion (95% CI) diagnosed with a new SARS-CoV-2 infection confirmed by a positive PCR test
Time frame: 0 - 6 months
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