ABSTRACT
Background: A single-stranded mRNA virus SARS-CoV- 2 is associated with severe acute respiratory syndrome in the predisposed individuals such as elderly, obese, chronic cardiovascular or pulmonary diseases. Higher risk for severe course was also reported in inborn errors of immunity (IEI). While restriction measures play important role from the short-term perspective, vaccination may provide long-term protection. However, only limited data are available on safety and efficacy in immunocompromised patients with IEI such as Common variable immunodeficiency (CVID). Method(s): We assessed humoral and cellular responses, safety and efficacy in a cohort of 20 CVID patients after 2 doses of anti-SARS- CoV- 2 vaccine BNT162b. The humoral reponse was evaluated using ELISA and western blot methods, the T cell response measured by IFNg secretion functional assay. Adverse events were reported by Patient Clinical Questionnaire. Blood count, biochemical, coagulation and immunological parameters were checked before and after vaccination. The patients were followed for 6 months. Result(s): Despite severely impaired antibody production hunoral response was detected in 48% (n = 10/21) of patients at month 1. However, the response persisted in only 33% (n = 6/18) at month 3 and further decreaed to 13% (n = 2/15) at month 6. The T cell response was measurable in 5 patients (28%) at month 1. In total, 4 out of 20 (20%) patients got infected within the study period. None of them required oxygenotherapy or hospital admission. We did not observe any severe adverse effects beyond local pain, fatigue, headche, fever, arthralgia and myalgia. Conclusion(s): Vaccination with mRNA vaccine BNT162b provides safe and effective protection for a subgroup of CVID patients. However, the immunogenicity is lower compared to the general population.
ABSTRACT
SUMMARY Intradermal tests are important part of allergy testing in individuals with suspected hypersensitivity to vaccines or its compounds. According to previous findings, intradermal tests with Comirnaty vaccine causes delayed skin reaction considered to be a proof of existing cellular antiviral immunity. Our research confirmed delayed skin reactions after intradermal tests with Comirnaty not only in previously vaccinated individuals but also in not vaccinated volunteer. Therefore, we do not recommend using this test either for cellular immunity, evaluation or for delayed type of hypersensitivity assessment.
ABSTRACT
Background: Common variable immunodeficiency (CVID) is a heterogeneous group of disorders characterized by the disturbed production of immunoglobulin and specific antibodies. CVID usually manifests with recurrent bacterial respiratory tract infections, although broad spectrum of non-infectious complications affecting lungs and many other vital organ systems may develop. Therefore, CVID patients may be recognized as a risk group for Covid-19 infection and the vaccination should be considered despite of the terrain of humoral immunodeficiency. However, only limited data are available on the safety of mRNA vaccine in CVID patients Method: A single-center prospective observational study focused on the safety of mRNA vaccine Comirnaty administration in a cohort of CVID patients. Only patients who had met inclusion and exclusion criteria were enrolled upon signed written informed consent. Total blood count with differential, coagulation, biochemistry and immunologic parameters were assessed before a first dose of the vaccine (Day 0), then at Day 21 (before a second dose) and at Day 51. The study was approved by Motol University Hospital Ethic Committee. Results: Together 25 CVID patients were included into the study. The most reported adverse events were local pain, fatigue, myalgia, arthralgia or increased body temperature. Neither severe adverse events nor anaphylaxis were reported. No safety concern were also revealed in the evaluated laboratory parameters. Conclusion: The administration of mRNA vaccine Comirnaty in the terrain of CVID-severely impaired humoral immunity is safe. However, there is an open question of its efficacy, particularly from the point of view of T cell response that plays crucial role in antiviral immunity.
ABSTRACT
It has been a year since the first person on Earth became infected with a new type of coronavirus SARS-CoV-2, causing infectious acute respiratory disease COVID-19 with relatively high morbidity and mor-tality. The most endangered population by coronavirus SARS-CoV-2 are healthcare professionals, the elderly and people with associated comorbidities. Due to the fast community spread, governments of different European countries introduced precaution measures including limited socializing of people, closing of most public services and introducing mandatory facial protection. The hope for a return to the life before the pandemic is the development of an effective and safe vaccine against SARS-CoV-2 which would presumably reduce the incidence of severe forms of COVID-19 and prevent the massive spread of the disease. At the end of November, we have 13 clinical trials in phase III involving SARS-CoV-2 vaccines based on inactivated viruses, recombinant non-pathogenic viral vectors and proteins. The first mRNA-based vaccine is currently being evaluated in phase II/III clinical trial and is already being distrib-uted and applied to high-risk population in the United Kingdom, the United States, and Israel, followed by the countries of the European Union, including the Czech Republic. In the review article we present currently ongoing clinical studies with a special focus on the phase III clinical trials and discuss the mechanisms of action of each type of vaccine. © 2020, Czech Medical Association J.E. Purkyne. All rights reserved.