FullText of Open Label Trial of Therapeutic Hepatitis B Vaccine V-5 Immunitor

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Open-label trial of therapeutic immunization with oral V-5 Immunitor (V5) vaccine in patients with chronic hepatitis C
Dendev Batdelgera, Dorjiin Dandiib, Vichai Jirathitikalc and Aldar S. Bourinbaiarc, ,

aNational Research Center for Infectious Diseases (NRCID), Ulaanbaatar, Mongolia

bMonserum LLC, Ulaanbaatar, Mongolia

cImmunitor USA Inc., College Park, MD 20740, USA

Received 21 December 2007;  revised 26 February 2008;  accepted 12 March 2008.  Available online 1 April 2008.

Summary
We evaluated whether V-5 Immunitor (V5) – tableted therapeutic bivalent vaccine comprising heat-inactivated HCV 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 C in an open-label study that lasted 1 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 157.7 ± 73.4 to 49.9 ± 43.8 U/L (P = 0.0013) and 147.0 ± 79.2 to 58.7 ± 56.6 U/L (P = 0.0132), for ALT and AST, respectively. The AST/ALT ratio has improved from 0.93 to 1.18 (P = 0.00058) indicating the reversion of progression to cirrhosis. None of intent-to-treat patients who were anti-HCV antibody positive at study entry, became negative after 1 month on V5 (P = 0.998). All patients, except one, reported complete recuperation from hepatitis C-associated clinical symptoms present at baseline (P = 0.0016) with Mantel Haenszel's odds ratio 9.4 (P = 0.0021) at 95% confidence interval: 2.7 < OR < 476.3. No adverse events were observed at any time. The favorable biochemical and clinical responses have been observed in a small number of individuals for a limited time period. Larger scale and longer studies are needed to confirm our preliminary observations suggesting that V5 is safe and effective means for immunotherapy of chronic hepatitis C.

Keywords: Alloimmunization; Liver function test; Therapeutic vaccine; Immunomodulation; Per os

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