Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid (mRNA) Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An Open and Non-randomized, Phase IV Multicenter Study

2021-000175-37

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.

2021-02-23

2024-03-31

2025-12-31

Active (not recruiting)

Early phase I

540

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

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2023-09-05