The study is designed as an open, non-randomized, phase IV cohort study in which the mRNAvaccine Comirnaty will be given in two doses. Analyses will be performed on blood andsaliva, investigating humoral and cellular vaccine responses. Occurence of local orsystemic reactogenicity will be evaluated, as well as adverse events. The study willinclude persons with primary or secondary immunosuppressive disorders, as well asimmunocompetent persons, with the aim of investigating if the immune responses aftergiven 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.
Biological: Comirnaty (COVID-19, mRNA vaccine)
Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.
Other Name: tozinameran,Pfizer mRNA vaccine
Inclusion Criteria:
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 Criteria:
1. Previous or ongoing Coronavirus Disease-19 (COVID-19).
2. 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.
3. 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
4. Pregnancy or breast feeding.
5. Hypersensitivity to the active substance or to any of the excipients contained in
the vaccine
6. Individuals who cannot understand the informed consent.
7. Individuals who for other reasons are considered by investigators as not suitable
for inclusion
Karolinska University Hospital
Stockholm, Huddinge, Sweden
Soo Aleman, MD, PhD, Principal Investigator
Karolinska University Hospital, ME Infectious Diseases