HBVAXPRO Suspension for injection Ref.[9864] Active ingredients: Hepatitis B, purified antigen

Pharmacotherapeutic group: anti-infectious
ATC code: J07BC01

The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Development of an antibody titre against hepatitis B virus surface antigen (anti-HBsAg) equal to or greater than 10 IU/l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.

In clinical trials, 96% of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck’s recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen (≥10 IU/l). In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5% and 97.2% with geometric mean titres of 214 and 297 IU/l, respectively.

The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck’s recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg). Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.

Although the duration of the protective effect of a previous formulation of Merck’s recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.

In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck’s recombinant hepatitis B vaccine. As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present. The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.

Reduced risk of Hepatocellular Carcinoma

Hepatocellular carcinoma is a serious complication of hepatitis B virus infection. Studies have demonstrated the link between chronic hepatitis B infection and hepatocellular carcinoma and 80% of hepatocellular carcinomas are caused by hepatitis B virus infection. Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.