Preclinical study of 5-in-1 vaccine of combination of conjugated Hib component with diphtheria, pertussis, tetanus, and hepatitis B components for producing vaccine at laboratory scale

Abstract

A preclinical study was performed on animals with the aim of evaluating the safety and immunogenicity of the combination of the Hib conjugate component (PRP-TT) with the diphtheria components, tetanus, pertussis (whole cell and acellular) and hepatitis B are included in the 5-in-1 combination vaccine. The study was conducted by evaluating two kind combination protocols: the P1 formula (including Hib antigen, diphtheria monolithic antigen, whole cell pertussis, tetanus, hepatitis B and P2 formula (including Hib antigen, diphtheria monolithic antigen, acellular pertussis, tetanus, hepatitis B). The results showed that all formulas met physical and chemical standards that were within WHO permitted limits on pH, formaldehyde, thimerosal, and aluminum content. The safety assessment results on rats showed that 100% of rats were healthy, with no abnormal signs. The effectiveness of each component antigen in rats are standard approved by the World Health Organization. The obtained results of this study is confrmed the PRP-TT ingredient, which produced by VABIOTECH is eligible to be used as an ingredient in the 5 in 1 combined vaccine.