Reactogenicity of the 10-Valent Pneumococcal Conjugate Vaccine in Animal Models

Abstract

Streptococcus pneumoniae poses significant global health challenges, particularly among vulnerable populations such as infants and the elderly. The 10-valent Pneumococcal Conjugate Vaccine (PCV-10) is a commonly utilized vaccination modality, necessitating a comprehensive understanding of its safety profile. This research aims to evaluate the safety of PCV-10 through controlled in-vivo assessments, with a focus on adverse events including pain, swelling, heat, redness, and dizziness. The study employed an experimental design involving nine White New Zealand rabbits, divided into three cohorts. Each cohort consisted of two experimental and one control rabbit. PCV-10 vaccine administration replicated the infant vaccination schedule across the three cohorts, with each receiving three doses. Vaccine reactogenicity was assessed through adverse events recorded up to seven days post-administration, with parameters including redness, fever, drowsiness, appetite loss, swelling, irritability, fainting, and movement challenges. Data analysis was conducted using Microsoft Excel 2016. Results indicated that rabbits in cohort I generally exhibited mild to moderate pain and heat. Swelling and redness were mostly absent or mild after vaccine doses. Dizziness, absent after the first dose in cohort I, occurred with mild to moderate severity after subsequent doses. Rabbits in cohorts 2 and 3 experienced greater intensity of dizziness. Overall, adverse events were generally mild to moderate, varying across cohorts and doses. This study suggests a manageable reactogenicity profile for PCV-10 and recommends informing patients about possible adverse events, advising them to notify healthcare providers if such events persist.