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TetraFluBet: A Tetravalent Influenza Vaccine Enhanced with Natural Betulin Adjuvant

Irina Tcymbarevich1, Anna Krasheninnikova1, Maria Sukhova1, Aleksandr Ivanov1, Marina Stukova2, Ekaterina Romanovskaya-Romanko2, Nataliya Mikhailova3, Anton Belkin4, Olga Belyakova1, Alevtina Nicolaeva4 and Igor Krasilnikov1*

Influenza is well-known to have a considerable influence on the healthcare system; therefore, vaccination plays a significant role in dealing with severe consequences. Close attention is paid to the development of tetravalent adjuvanted vaccines containing antigens of two influenzas A subtypes (H1N1, H3N2) and two influenza B subtypes (Victoria, Yamagata) to increase the effectiveness of influenza prevention. In this work, we present the results of an animal study of an innovative subunit tetravalent candidate influenza vaccine with the addition of betulin as an adjuvant, TetraFluBet. The study was conducted using female BALB/c mice, male and female mongrel rats, and guinea pigs. TetraFluBet was injected intraperitoneally twice in a 14-day interval prior to intranasal infection with 100LD50. Sub-chronic toxicity was assessed by immunohistochemistry of extracted organs and by hematological and biochemical blood parameters in guinea pigs and mongrel rats. Protectivity and immunogenicity were evaluated using the hemagglutination inhibition assay in mice. The sub-chronic toxicity study did not reveal any side effects of the candidate TetraFluBet vaccine on both rats and guinea pigs. One vaccination dose of TetraFluBet provided a pronounced degree of protective effect and significantly increased antibody titers of four influenza subtypes in response to double immunization. The candidate vaccine TetraFluBet confirmed its safety along with specific activity, showed high immunogenicity, and can be recommended for further clinical studies.