The article summarizes the WHO materials, regulations of normative documents, scientific publications’ data from certain foreign countries and Russia concerning interchangeability of vaccines against viral hepatitis B for immunization of adult population. The implemented analysis of data of foreign and Russian studies demonstrated compatibility of vaccine against viral hepatitis B from different manufacturers by parameters of immunological, preventive and epidemiological effectiveness that permits assuming possibility of their equivalent substitute.
The review summarizes the WHO materials and recommendations the latest editions of the official guidelines of the Ministries of Health Australia, Canada, Great Britain, Germany, Russia, USA, through the vaccination of viral hepatitis B. Special attention is paid to the immunization of persons belonging to the group of increased risk of the infection, the implementation of which is not fully defined in relation to native normative documents: the immunocompromise, hemodialyse, diabetic patients and healthscare personel.
The immunologic activity (specific activity) is one of the main indicators of quality of vaccines for prophylaxis of hepatitis B, along with their safety. Retrospective analysis of the use of laboratory methods for assessment of specific (immunogenic) activity of modern vaccines against hepatitis B using indicators was carried out: in vitro method based on evaluation of HBsAg content and in vivo method based on evaluation of immunogenic activity in mice. Both methods are standardized and described in normative documents on the vaccines against hepatitis B of domestic production registered in the Russian Federation. Indicators of specific (immunogenic) activity of vaccines against hepatitis B were used to investigate more than 170 vaccine series using the ELISA method in the period from 2013 to 2015. The obtained control results confirmed the expediency and efficiency of enzyme immunoassay for determination of HBsAg content, as well as permissibility of use of ready sets of the Murex HBsAg Version 3 test systems for testing vaccines against hepatitis B by the ELISA method. Analysis of the results of laboratory control of series of vaccines against hepatitis B using a biological method for immunogenicity evaluation based on ED50 analysis confirms persistently high immunogenic activity of the Russian commercial vaccines intended for prophylaxis of hepatitis B. The confirmed comparability of methods allows the number of in vivo tests to be further reduced in favor of the enzyme immunoassay authentically characterizing the produced drug.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.