Journal of Vaccines & Vaccination

Abstract

Efficacy Of Double Dose Intradermal Vaccination In Chronic Hepatitis B Carriers: A Double-Blinded Randomized Clinical Trial

Fariborz Mansour-Ghanaei, Farahnaz Joukar, Davood Khalili and Ali Kord Valeshabad

Background: Specific vaccine therapies have been proposed recently as possible alternative treatment modalities to interferon and antiviral drugs to enhance the immune response in HBV chronic carriers through induction of T cell activity which can lead to control viremia. To assess the efficacy of long term intradermal (ID) hepatitis B virus (HBV) vaccination with double standard dose as an active immunotherapy in elimination of HBV infection in chronic hepatitis B carriers. Materials and Methods: This double-blinded randomized clinical trial was conducted on all HBsAg positive patients. Among them 80 immunotolerant patients were recruited and randomly allocated to alternate study groups (vaccination or placebo) consecutively. Eligible healthy carriers in group 1 were assigned to vaccinate with six ID injections of the Heberbiovac HB vaccine at 30-day intervals and with double standard doses (2cc) in two forearms. Controls received normal saline with the same setting as a placebo. The mean ALT levels, detectable HBV DNA and seroconversion to anti-hepatitis B e antigen (anti-HBe) and anti hepatitis B surface antigen (anti-HBsAb) compared between groups at the beginning and the 6th and 12th months. Results: No significant difference was found in the mean ALT values, the clearance of HBV DNA, seroconversion from HBeAg to HBeAb and developing of HBsAb between vaccinated and control group at the end of the 6th and 12th months (P>0.05). Conclusion: Intradermal administration, even with double standard dose, is not an efficient treatment in the elimination of virus in chronic carriers of HBV.