Clinical trials of a pentavalent combined vaccine with whole-cell pertussis antigen DTP-HepB+Hib – a Pentavaccine, developed by National Immunobiological Company (Natimbio) with affiliated company NPO Microgen. A marketing authorization dossier is prepared, and it is expected that the vaccine will emerge in the market in 2017
The New Pentavaccine DTP-HepB+Hib also protects against hemophilus influenza, thanks to its Hib-compoenent, as opposed to the already authorized product.
It is of note, that the pertussis component of DTP vaccines is poorly tolerated by infants, but still epidemiologists consider immunization a required measure, that is why less reactogenic pertussis vaccines are introduced, now also manufactured in Russia.
NPO Microgen developed an original technology of obtaining a pentavalent combination vaccine (DTaP-HepB+Hib), containing acellular pertussis component with lower level of endotoxins and an antigenic structure similar to that of the whole-cell pertussis vaccine. Clinical trial “Assessment of safety, reactogenicity and immunogenicity of DTaP-HepB+Hib” is proceeding to completion. As opposed to Hepatitis B monovaccine, DTaP-HepB+Hib contains twice lower amount of hepatitis B viral antigen. As opposed to international accelular pertussis based vaccines, authorized in Russia, the local vaccine contains twice as less tetanus and 1.25-1.5-fold less diphtheria antigens, while immunological activity is preserved.