Avaliação da potência do componente da Hepatite B nas vacinas combinadas pentavalentes (DTP/HB/Hib) de diferentes produtores

The Brazilian National Immunization Program (PNI) was created in 1973, during the formulation of the most important national programs in Brazil. Starting on August, 2012, PNI has introduced the Pentavalent Combined Vaccine as part of the children basic calendar, unifying in one dose the protection against five diseases (diphtheria, tetanus, pertussis, Haemophilus influenza type b and hepatitis B). Hepatitis B is a disease caused by the infection of Hepatitis B virus (HBV), a DNA virus from Hepadnaviridae family. The HBV external involucre contains antigenic proteins that are the hepatitis B virus surface antigen (HBsAg). The World Health Organization calculates that over 240 million people around the world are chronically infected by HBV. The challenge for the development and introduction of the combined vaccines is mostly about the potential of antigenic interaction. Thus, the efficacy and safety of each component must be individually evaluated and in its final form through quality control assays. Among the preconized assays, the potency test is the assay that evaluates the vaccines effectiveness. The purpose of this work is to evaluate the potency of hepatitis B component in pentavalent combined vaccines (DTP/HB/Hib) from different manufacturers through in vitro methodology based on enzyme linked immunosorbent assay – ELISA. Moreover, were also evaluated the interference of the other components (DTP and Hib) and the aluminum phosphate adjuvant contained in the different vaccine formulations, stability study in stress situations on 60oC for seven days and the comparison of using commercial kits Murex and Enzygnost. A total of seventeen samples of pentavalent combined vaccine with HBsAg component from two different producers (A and B) kept from 2oC to 8oC were selected for this study. The methodology for the in vitro assay was established to evaluate the potency of pentavalent combined vaccine (DTP/HB/Hib) samples from producers A and B. The results showed that there is no interference with diphtheria, tetanus, pertussis and Haemophilus influenzae type b antigens when evaluating the potency of HBsAg component. The combined vaccines lots 1622/12 and 3032/12 were elected as internal reference to producer A and producer B, respectively. The commercial kits selected (murex and enzygnost) were appropriate for the purpose of this study.