Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency.

Mikhail P Kostinov,Valentina B Polichshuk,Ekaterina A Khromova,Tatyana V Latysheva,Aristitsa M Kostinova,Yulia A Dagil,Elena A Latysheva,Anna E Vlasenko,Nelly K Akhmatova

doi:10.3390/vaccines8040640

Abstract

Background. Influenza prophylaxis with the use of quadrivalent vaccines (QIV) is increasingly being introduced into healthcare practice. Methods. In total, 32 healthy adults and 6 patients with common variable immunodeficiency (CVID) received adjuvant QIV during 2018–2019 influenza season. Depending on initial antibody titers, healthy volunteers were divided into seronegative (≤1:20) and seropositive (≥1:40). To evaluate immunogenicity hemagglutination inhibition assay was used. Results. All participants completed the study without developing serious post-vaccination reactions. Analysis of antibody titer 3 weeks after immunization in healthy participants showed that seroprotection, seroconversion levels, GMR and GMT for strains A/H1N1, A/H3N2 and B/Colorado, B/Phuket among initially seronegative and seropositive participants meet the criterion of CHMP effectiveness. CVID patients showed increase in post-vaccination antibody titer without reaching conditionally protective antibody levels. Conclusion. Adjuvant QIV promotes formation of specific immunity to vaccine strains, regardless of antibodies’ presence or absence before. In CVID patients search of new regimens should be continued.

Highlights

The novel coronavirus is currently causing a global pandemic, influenza continues to be one of the diseases capable of affecting the population, causing seasonal epidemics and sporadic pandemics, due to the emergence and spread of new influenza viruses
Numerous studies have proved the safety and immunogenicity of quadrivalent inactivated influenza vaccines (QIV) compared to trivalent inactivated influenza vaccines (TIV) and antibody production in protective titers against additional B lineage, that indicates the advantage of vaccines containing two lineages of type B influenza virus due to the increase in the immune layer of population to influenza infection [6,7,8,9,10,11]
Given the limited number of patients with common variable immunodeficiency (CVID) (6), first we provide an assessment of the immunogenicity of adjuvant QIV (aQIV) in the group of healthy people, and individually for each CVID patient

Summary

Introduction

The novel coronavirus is currently causing a global pandemic, influenza continues to be one of the diseases capable of affecting the population, causing seasonal epidemics and sporadic pandemics, due to the emergence and spread of new influenza viruses. The epidemiological effect of vaccination of population against seasonal influenza can be increased by including strains of both influenza B lineages. Numerous studies have proved the safety and immunogenicity of quadrivalent inactivated influenza vaccines (QIV) compared to trivalent inactivated influenza vaccines (TIV) and antibody production in protective titers against additional B lineage, that indicates the advantage of vaccines containing two lineages of type B influenza virus due to the increase in the immune layer of population to influenza infection [6,7,8,9,10,11]. Analysis of antibody titer 3 weeks after immunization in healthy participants showed that seroprotection, seroconversion levels, GMR and GMT for strains A/H1N1, A/H3N2 and B/Colorado, B/Phuket among initially seronegative and seropositive participants meet the criterion of CHMP effectiveness. In CVID patients search of new regimens should be continued

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Discussion

Conclusion