TOLERABILITY OF EXCIPIENTS OF A VACCINE FORMULATION IN OUTBRED WHITE LABORATORY MICE
B. Yespembetov,
S. Alpysbayeva,
M. Sarmykova,
A. Kerimbayev,
A. Abdimukhtar,
Ye. Serikbay,
K. Shorayeva,
N. Asanzhanova,
N. Syrym,
A. Shestakov,
A. Toleukhan,
A. Anarbekova,
M. Maulenbayeva,
B. Yerzhigit,
A. Abdykalyk https://doi.org/10.58318/2957-5702-2025-24-23-28
Abstract
The present study evaluated the local and systemic tolerability of vaccine formulation components in the absence of antigen following intranasal and sublingual administration in outbred white laboratory mice. The investigated substances included excipients of the vaccine formulation mannitol and gelatin at various concentrations as well as phosphate-buffered saline and water for injection, which are used as technological components during the development of vaccine candidates. The control group consisted of intact animals.
Tolerability was assessed over a 10-day observation period based on clinical condition, body weight dynamics, and key blood biochemical parameters. All tested substances demonstrated good tolerability: no clinically significant local or systemic reactions were observed, and the evaluated biochemical parameters remained within reference ranges. Based on the overall assessment, mannitol at a concentration of 5% and gelatin at 0.5% were identified as optimal.
The obtained results indicate the safety of the investigated excipients and technological components and confirm their suitability for use at the preclinical stage of development of vector-based anti-brucellosis vaccine candidates utilizing an influenza virus platform.
Supporting agencies: This study was supported by the Committee of Science of the Ministry of Science and Higher Education of the Republic of Kazakhstan under grant No. BR25293294 entitled Vaccine against brucellosis based on genomic technologies for the period 2024 to 2026
About the Authors
B. Yespembetov
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
S. Alpysbayeva
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
M. Sarmykova
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
A. Kerimbayev
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
A. Abdimukhtar
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
Ye. Serikbay
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
K. Shorayeva
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
N. Asanzhanova
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
N. Syrym
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
A. Shestakov
Ulyanovsk State Agrarian University named after P.A. Stolypin
Russian Federation
Russian Federation
Ulyanovsk
A. Toleukhan
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
A. Anarbekova
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
M. Maulenbayeva
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
B. Yerzhigit
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
A. Abdykalyk
LLP «Research Institute for Biological Safety Problems», National holding «QazBioPharm»
Kazakhstan
Kazakhstan
Guardeyskiy
References
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Review
For citations:
Yespembetov B., Alpysbayeva S., Sarmykova M., Kerimbayev A., Abdimukhtar A., Serikbay Ye., Shorayeva K., Asanzhanova N., Syrym N., Shestakov A., Toleukhan A., Anarbekova A., Maulenbayeva M., Yerzhigit B., Abdykalyk A. TOLERABILITY OF EXCIPIENTS OF A VACCINE FORMULATION IN OUTBRED WHITE LABORATORY MICE. Biosafety and Biotechnology. 2025;(24):23-28. https://doi.org/10.58318/2957-5702-2025-24-23-28
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