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Open Label Trial of Therapeutic Hepatitis B Vaccine V-5 Immunitor (V5)Delivered by Oral Route

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We evaluated whether V-5 Immunitor (V5), tableted immunotherapeutic preparation comprising heatinactivated HBV antigens from pooled blood of HBV- and HCV-infected donors, may produce clinical benefit through induction of oral tolerance and reduction of immune-mediated liver injury. Once daily dose of V5 was administered per os to 10 patients with chronic hepatitis B in an open label study that lasted one month. Every patient who entered the study had elevated liver enzyme levels, which at the end of study have decreased in 100% of analyzed patients. The reduction was highly significant, from 112.4 to 44.4 U/L (P=0.00009) and 118.8 to 46.1 U/L (P=0.0032), for ALT and AST respectively. In addition, half of intent-to-treat patients who were HBV surface antigen (HBsAg) positive at study entry, became negative after one month on V5 (P=0.0098). All patients, except one, reported complete recuperation from hepatitisassociated clinical symptoms present at baseline (P=0.0016). No adverse events were observed at any time. Favorable biochemical, virological and clinical responses indicate that V5 is safe and effective means for immunotherapy of chronic hepatitis B. Placebo-controlled, randomized study is required to confirm these findings.

Keywords: Hepatitis B; Immunomodulating supplement; Liver function test; Therapeutic vaccine; per os

Document Type: Research Article

Publication date: December 1, 2007

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  • Letters in Drug Design & Discovery publishes original letters on all areas of rational drug design and discovery including medicinal chemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, and structure-activity relationships. The emphasis will be on publishing quality papers very rapidly. Letters will be processed rapidly by taking full advantage of Internet technology for both the submission and review of manuscripts. The journal is essential reading to all pharmaceutical scientists involved in research in drug design and discovery.
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