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

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.

Vaccination against Influenza: Clinical and Cytokine Profile of Patients with Asthma and Chronic Obstructive Pulmonary Disease

“…Grippol Plus, the Russian trivalent polymer-subunit vaccine with a reduced (3-fold) content of epidemically relevant strains of influenza virus subtypes A (H1N1, H3N2) and type B (total 15 µg HA) and azoximer bromide (500 µg), was used in asthma and COPD patients. The vaccine has been used for more than 25 years within the framework of the National Immunization Schedule in children from 6 months of age without age restrictions, patients with various pathologies [35][36][37], and pregnant women [30,33,39,40]. Asthma and COPD patients were also vaccinated with this drug product, but it was not previously studied whether vaccination is accompanied by a change in the content of inflammatory mediators in the post-vaccination period and the considered immunological parameters.…”

Immunogenicity and Safety of the Spikevax® (Moderna) mRNA SARS-CoV-2 Vaccine in Patients with Primary Humoral Immunodeficiency

“…Although there are studies on this topic, the majority of them are on influenza virus vaccines and there are several limitations in these studies. Even though the humoral response seems to be decreased in a majority of IEI patients, specific cellular immune responses may be effective [22][23][24][25].…”

Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine.

“…Their findings are in line with those reported here, and they also provide supportive information on the practical use of quadrivalent AZB-SU vaccines. 35,36 In conclusion, the favourable safety profile and immunogenicity of AZB-SU vaccines, along with the reduced amount of antigen per dose and sparing effect of AZB, make AZB-SU vaccines good candidates for use not only during a pandemic or limited national capacity of vaccine production, but in general for seasonal influenza vaccination. Future research will be directed towards evaluating whether AZB also shows an antigen-sparing effect in elderly patients undergoing vaccination.…”

“…Their findings are in line with those reported here, and they also provide supportive information on the practical use of quadrivalent AZB-SU vaccines. 35 , 36 …”