The National Immunobiological Company (Nacimbio) has finished the clinical trials of the first Russian combined pentavalent vaccine aDPT-Hep B+Hib with acellular pertussis component. The drug has demonstrated safety and immunological potency. The state registration of the drug is expected to occur in 2018.
The pentavaccine developed by the Scientific and Production Association Microgen contains components allowing to perform vaccination against five diseases at once (diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenza) following the "single injection" approach – without the necessity to introduce several monovalent vaccines individually.
The new pentavaccine will decrease the number of required injections and, due to inclusion of an acellular pertussis component, will be well tolerated by patients. It is the pertussis component that makes DPT vaccines one of the vaccines that are most poorly tolerated by children of senior age and adults.
"The results of the clinical trials are good. They confirm safety and immunological potency of the drug. All reactions during the vaccination occurred independently, without any need for additional therapy", added Kirill Gaidash, General Director of NPO Microgen.
The aDPT-Hep B+Hib drug is produced by the company using a custom-tailored technology with a low level of endotoxins of acellular pertussis component, and twice as low level of tetanus, diphtheria components and hepatitis B virus antigen, while preserving the immunologic activity of the vaccine.
