Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Pre‐Clinical Study of Subunit Betulin‐Adjuvanted Tetravalent Candidate Influenza Vaccine: TetraFluBet

Irina Tcymbarevich
ORCID logo ,
Anna Krasheninnikova
,
Aleksandr Ivanov
ORCID logo ,
Marina Stukova
,
Ekaterina Romanovskaya-Romanko
,
Nataliya Mikhailova
,
Anton Belkin
,
Olga Belyakova
,
Alevtina Nicolaeva
,
Igor Krasilnikov
* ORCID logo
Version 1 : Received: 4 December 2023 / Approved: 5 December 2023 / Online: 5 December 2023 (15:29:12 CET)

How to cite: Tcymbarevich, I.; Krasheninnikova, A.; Ivanov, A.; Stukova, M.; Romanovskaya-Romanko, E.; Mikhailova, N.; Belkin, A.; Belyakova, O.; Nicolaeva, A.; Krasilnikov, I. Pre‐Clinical Study of Subunit Betulin‐Adjuvanted Tetravalent Candidate Influenza Vaccine: TetraFluBet. Preprints 2023, 2023120277. https://doi.org/10.20944/preprints202312.0277.v1 Tcymbarevich, I.; Krasheninnikova, A.; Ivanov, A.; Stukova, M.; Romanovskaya-Romanko, E.; Mikhailova, N.; Belkin, A.; Belyakova, O.; Nicolaeva, A.; Krasilnikov, I. Pre‐Clinical Study of Subunit Betulin‐Adjuvanted Tetravalent Candidate Influenza Vaccine: TetraFluBet. Preprints 2023, 2023120277. https://doi.org/10.20944/preprints202312.0277.v1

Abstract

Influenza is well-known to have a considerable influence on 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 influenza 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 pre-clinical study of innovative subunit tetravalent candidate influenza vaccine, with addition of betulin as adjuvant, TetraFluBet. The study was conducted using female BALB/c mice, male and female mongrel rats and guinea pigs. TetraFluBet and commercially available vaccines were injected intraperitoneally twice in a 14-day interval after intranasal infection with 5LD50 and 10LD50. Chronic toxicity was assessed by immunohistochemistry of extracted organs and by hematological and biochemical blood parameters. Protectivity and immunogenicity were evaluated using hemagglutination inhibition and microneutralization with MDCK assays. Chronic toxicity study did not reveal any side effects of candidate TetraFluBet vaccine on both rats and guinea pigs. One vaccination dose of TetraFluBet provided 100% protectivity against all 4 influenza subtypes and significantly increased neutralizing antibody activity in response to immunization of influenza subtypes. Pre-clinical candidate vaccine TetraFluBet confirmed its safety along with specific activity, showed high immunogenicity and can be recommended for further clinical studies.

Keywords

influenza vaccine; seasonal influenza; pandemic influenza; adjuvant; subunit vaccine; SARS-CoV-2; betulin

Subject

Biology and Life Sciences, Immunology and Microbiology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download PDF Download Supplementary

Comments (0)

We encourage comments and feedback from a broad range of readers. See criteria for comments and our Diversity statement.

Leave a public comment
Send a private comment to the author(s)
* All users must log in before leaving a comment
Views 0
Downloads 0
Comments 0
Metrics 0
Get PDF Supplementary Files Cite Share 0
Bookmark BibSonomy Mendeley Reddit Delicious
×
Alerts
Notify me about updates to this article or when a peer-reviewed version is published.
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here.