Comparative Assessment of Reactogenicity and Immunogenicity of Commercial Influenza Inactivated Vaccines: Polymer-Subunit Grippol plus, Subunit Influvac, Split Vaccine Waxigrip

Харит, С. М.; Lioznov, Dmitry; Рулёва, А. А.; Фридман, И. В.; Чирун, Н. В.; Апрятина, В. А.

doi:10.31631/2073-3046-2017-16-2-24-30

Cited by 3 publications

(2 citation statements)

References 8 publications

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“…Studies have shown that in people vaccinated with the adjuvant influenza vaccine, the respiratory infection rate is about 9%; in those vaccinated with a subunit vaccine, it is 14%; and in those with a split vaccine, it is 11% [ 40 ]. Therefore, the absence of specific antibodies to influenza virus strains in patients with CVID in protective values does not mean that they did not form protection against influenza with the involvement of T-cell mechanisms of the immune response.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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“…As confirmed with numerous studies, vaccination is the most effective strategy in dealing with influenza infection, preventing complications and virus-related deaths [5,6,9,10]. In 1976 WHO published its first guidelines on strain composition of influenza vaccines; since then these recommendations are revisited every year to meet high evolutionary variability of influenza viruses [11].…”

Section: Introductionmentioning

confidence: 99%

The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old

et al. 2020

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Russian health care workers currently use trivalent influenza vaccines with a strain of a single lineage of type B virus. The purpose of our study was to evaluate the immunogenicity of an adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old. We compared this new vaccine to a trivalent Grippol Plus vaccine in terms of immunogenicity against certain strains of influenza virus. A multicenter double-blind randomized controlled clinical study was conducted in 440 pediatric subjects (age groups: 6 to 11; 12 to 17 y.o.); 221 subjects received Grippol Quadrivalent, 219 – Grippol Plus. Vaccine immunogenicity was evaluated by seroprotection rate (SPR), seroconversion rate (SCR), geometric mean titer (GMT) of antibodies, and an X-fold rise in antibodies level (↑GMT). Antibodies quantification was done using hemagglutination inhibition assay (HAI) in serial serum dilutions. No significant differences were found between the two vaccines’ performance against A(H1N1), A(H3N2) strains or Victoria B virus. With respect to type A virus, both vaccines satisfied three of CPMP criteria (SPR, SCR, ↑GMT). With respect to Victoria B virus, the two vaccines met but one CPMP criterion (↑GMT). The immunogenicity against Yamagata B virus was evaluated only for Grippol Quadrivalent vaccine which met two of CPMP requirements (SCR, ↑GMT). Our findings suggest that in terms of its prophylactic efficiency, Grippol Quadrivalent vaccine is no inferior to the Grippol Plus one.

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Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)

Romanenko,

Namazova-Baranova,

Kotova

et al. 2024

Pediatr. farmakol.

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The article presents the results of a clinical investigation on the administration of the Grippol Quadrivalent vaccine (influenza tetravalent inactivated subunit adjuvant vaccine) in children from 6 months to 5 years old. The vaccine has demonstrated no less effectiveness in comparison with the Grippol plus vaccine (influenza trivalent inactivated polymer-subunit vaccine). Comparable results were obtained for all evaluated indicators of immunological efficacy against matching strains of the influenza virus, while for additional strain B (Yamagata line) there was a statistically significant difference in the increase in the immune response in the Grippol Quadrivalent group. The results of the assessment of the reactogenicity and frequency of systemic adverse events indicated a favorable and comparable safety profile of the vaccines Grippol Quadrivalent and Grippol plus in children from 6 months to 5 years old. The data obtained allowed us to conclude that the immunological efficacy of the Grippol Quadrivalent vaccine is no less when compared to the Grippol plus vaccine, as well as a comparable safety and reactogenicity profile. According to the results of the clinical investigation, on 08/04/2023, the Ministry of Health of the Russian Federation amended the “Instructions for the medical use of the drug”: Grippol Quadrivalent is indicated for children from the age of 6 months.

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Comparative Assessment of Reactogenicity and Immunogenicity of Commercial Influenza Inactivated Vaccines: Polymer-Subunit Grippol plus, Subunit Influvac, Split Vaccine Waxigrip

Cited by 3 publications

References 8 publications

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

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

The results of clinical trial on immunogenicity of adjuvanted quadrivalent inactivated subunit influenza vaccine Grippol Quadrivalent in pediatric population 6 to 17 years old

Results of a clinical study of the influenza tetravalent inactivated subunit adjuvant vaccine Grippol Quadrivalent in children aged 6 months to 5 years (inclusive)

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