title: Open-label trial of therapeutic immunization with oral V-5 Immunitor (V5) vaccine in patients with chronic hepatitis C.
abstract: 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.
authors.affiliation: National Research Center for Infectious Diseases (NRCID), Ulaanbaatar, Mongolia.
authors.forename: Dendev
authors.initials: D
authors.lastname: Batdelger
authors.forename: Dorjiin
authors.initials: D
authors.lastname: Dandii
authors.forename: Vichai
authors.initials: V
authors.lastname: Jirathitikal
authors.forename: Aldar S
authors.initials: AS
authors.lastname: Bourinbaiar
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D022482:Cytomegalovirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D018937:Hepatitis C Antibodies / Q000097:blood; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000276:immunology* / Q000503:physiopathology; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D022482:Cytomegalovirus Vaccines; D017325:Hepatitis B Vaccines; D018937:Hepatitis C Antibodies; C576355:V-5 immunitor; D014761:Viral Hepatitis Vaccines; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase