NGO Microgen completes the first national clinical research of pentavalent combination vaccine
The first domestic pentavalent combination vaccine (DTaP-HepB +Hib) by NGO Microgen, unlike its foreign counterparts, will be safer for use: it contains twice less tetanus antigen and 1.5 less diphtheria antigen, while retaining immune activity of foreign counterparts. The company is ready to fully meet the needs of the Russian Federation in such a vaccine, which is 5.5 million doses per year.
In contrast to the monovalent hepatitis B, a new vaccine contains 2 times less of the hepatitis B virus antigen HBsAg. Another important advantage of the new vaccine DTaP-HepB+ Hib manufactured by NGO Microgen is the absence of thiomersal, an organic compound containing mercury.
The original technology of producing the pentavalent combination vaccine was developed by a branch of the NGO Microgen in Perm; it allows to obtain a vaccine comprising acellular pertussis components with reduced endotoxin content and antigenic structure similar to a whole-cell pertussis vaccine.
Specialists of NGO Microgen, according to the WHO Expanded Programme on Immunization, pay special attention to the combined vaccines in their studies that are a priority for modern vaccinology. Inclusion of new antigens into existing combination vaccines not only reduces the stress load on vaccinated, but increases the effectiveness of the vaccine within the National Immunization Schedule.
Preclinical studies of the general toxic effect, allergenic effects, local reactions, pyrogenic properties and immunogenicity demonstrated good tolerability, safety, weak reactogenicity and high immunogenicity, what allowed to move on to the first phase of clinical trials.
The evaluation of tolerability, safety and reactogenicity of the vaccine in the observations in healthy volunteers of both sexes aged 18 to 60 years. It was found that DTaP-HepB Hib has a good safety profile: evaluation of the results of general and biochemical blood tests, urinalysis and serum immunoglobulins over time revealed no statistically significant differences. No post-vaccination complications or adverse events were observed. This vaccine induced production of antibodies to all ingredients at a high level.
The results obtained allowed to proceed to the second phase of clinical studies on the safety and immunogenicity of the vaccine in question. Successful second phase of clinical trials will allow to add the novel effective vaccine to the national calendar of preventive vaccinations to immunize children against five diseases: diphtheria, tetanus and pertussis (DTP), and a new component for the prevention of hepatitis B and Hib infections.
For over a decade NGO Microgen remains the largest producer of vaccines for the National Immunization Schedule.