Immunogenicity of influenza tetravalent inactivated subunit adjuvant vaccine in healthy and in patients with primary immune deficiency

Abstract

Introduction. Vaccination is the most effective means of influenza prevention. The current epidemiological influenza situation in the world indicates that trivalent vaccines are not able to protect the population from all circulating strains of type B influenza virus, that necessitates the improvement and expansion of the composition of the vaccines.Aim of the study. To evaluate the immunogenicity of influenza tetravalent inactivated subunit adjuvant vaccine in healthy adults and in patients with common variable immune deficiency. Materials and methods. In a single-center, open-label, non-randomized, prospective, cohort, controlled study before the flu season 2018-2019 were involved 32 healthy volunteers aged 18- 50 years and the comparison group which consisted of 6 patients with a confirmed diagnosis of common variable immune deficiency (CVID). All patients received 1 dose (0,5 ml) of the first Russian quadrivalent inactivated subunit vaccine (IIV4) with a decreased amount hemagglutinin protein (20 mkg of influenza H-antigens instead of 60 mkg in standart nonadjuvant IIV4 in the world) due to the use of azoximer bromide (500 mkg per dose). The antibody levels against the influenza type A viruses (H1N1 and H3N2) and two type B viral cell lines (B/Yamagata and B/Victoria) were evaluated using a hemagglutination inhibition reaction. The seroprotection, seroconversion, geometric mean titer rates, CD-subpopulations (CD3+, CD4+, CD8+, CD16,56+, CD19+, CD21+) and expression of toll-like receptors 3, 8, 9 were analized. Results. Adjuvant IIV4 in healthy adults elicited comparable immune response for matched 4 influenza strains with explored non-adjuvant IIV4 in the world. Patients with common variable immune deficiency failed to form a protective humoral immune response to adjuvant IIV4 although CD-subpopulations and expression of toll-like receptors 3, 8, 9 were similar to healthy controls that may indirectly indicate the possibility of the formation of cellular immunity in response to vaccination in these patients. Conclusions. The use of adjuvant IIV4 allows to form protection against 2 circulating influenza B lineages without reduction of the immunogenicity in relation to influenza strains type A. To evaluate the effectiveness of the influenza vaccine in patients with PID it is necessary to study other mechanisms of the development of a postvaccinal immune response.