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2021, Number 1

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Biotecnol Apl 2021; 38 (1)

Preclinical toxicity of Cuban pneumococcal conjugate vaccine candidate PCV7-TT

González TY, Luque-Martínez Y, Mancebo-Rodríguez A, Acosta LE, León GA, Blanco GD, González TC, Fuentes MD, Gutiérrez MM, Sosa TI, Sánchez SS, Rodríguez NL, Verez BV, Valdés BY, García RD, Oliva HR

Language: English
References: 26
Page: 1211-1216
PDF size: 507.07 Kb.


ABSTRACT

Streptococcus pneumoniae is the principal causative agent of bacterial pneumonia, otitis media, meningitis as well as septicemia in children and elderly people. The World Health Organization considers this bacterium a significant health problem in many countries. Pneumococci comprise highly adapted commensals, their main reservoir on the mucosal surface of upper airways of carriers which enables transmission. Therefore, vaccines confer important protection. In this line, a new heptavalent conjugate vaccine against pneumococcal disease (PCV7-TT) has been developed. In this work, a repeated dose and local tolerance tests were performed in Sprague Dawley rats, as part of preclinical toxicity studies. Animals received four vaccine doses by intramuscular route at three concentration levels. They were tested for 43 days with dose intervals of 14 days each. Clinical observation, body weight, temperature, hematology, serum chemistry and pathological studies were designed. No clinical symptoms or deaths were recorded. Only slight swelling and hardening were observed at the immunization site. Body weight, temperature, hematology, serum chemistry were not changed. Similarly, there were no pathological alterations detected in organs, only a local response observed as a chronic inflammatory reaction similar to others vaccines having aluminum as adjuvant on its composition. Consequently, the PCV7-TT candidate vaccine is potentially safe and tolerable for human.


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