Avaxim 160 Mechanism of Action

Pharmacotherapeutic Group: Vaccine Against Hepatitis A. ATC code: J07BC02.
Pharmacology: Pharmacodynamics: This vaccine is prepared from hepatitis A virus cultured, purified and then inactivated by formaldehyde. It confers immunity against hepatitis A virus by inducing a higher antibody response than that obtained after passive immunisation with immunoglobulins. The antibodies appear soon after the first injection, and 14 days after vaccination, more than 90% of immunocompetent subjects are seroprotected (titres above 20 mIU/ml).
One month after the first injection, almost 100% of subjects have titres higher than 20 mIU/ml. Immunity may persist up to the 36^th month. In a study with 103 healthy subjects whose serology levels were monitored for 3 years after the first injection of AVAXIM 160 U, 99% still had, by the 36^th month, antibody titres of at least 20 mIU/ml against the hepatitis A virus.
Long-term persistence of a protective antibody level against the hepatitis A virus after a second dose (booster) of AVAXIM 160 U is not currently established. However, the available data suggest that the antibodies against the hepatitis A virus persist beyond 10 years after the second dose in healthy people.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Non clinical data reveal no special hazard for humans based on conventional studies of acute toxicity, repeated dose toxicity, local tolerance and hypersensitivity.