Tolerability of auxiliary components of the vaccine preparation in laboratory white outbred mice

Abstract

In the present study, the tolerability of vaccine composition components in the absence of an antigenic component was evaluated following intranasal and sublingual administration in white outbred laboratory mice. The investigated substances included excipients of the vaccine composition—mannitol (3%, 5%, 7%) and gelatin (0.3%, 0.5%, 0.7%)—as well as phosphate-buffered saline (PBS, 0.01 M, pH 7.2–7.4) used as a buffering medium, and water for injection employed as a technological solvent in the preparation of vaccine candidates. Intact animals served as the control group. The substances were administered sublingually (50 µL) and intranasally (30 µL).

Over a 10-day observation period, local (mucosal) and systemic tolerability of the investigated substances was assessed based on body-weight gain, clinical condition of the animals, and blood biochemical parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities, as well as total bilirubin, glucose, and total protein levels. All tested substances demonstrated good tolerability: body-weight gain remained within physiological limits, local reactions at the mucosal level were absent or minimal, no systemic clinical manifestations were observed, and blood biochemical parameters remained within reference ranges. Based on the overall assessment of the evaluated parameters, mannitol at a concentration of 5% and gelatin at 0.5% were identified as optimal.

The obtained data indicate the safety of the investigated components and technological media and may be applied at the stage of developing manufacturing technology for vector-based anti-brucellosis vaccine candidates based on the influenza virus.