Abstract
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, Liver function test, Therapeutic vaccine, Immunomodulating supplement, per os
Letters in Drug Design & Discovery
Title: Open Label Trial of Therapeutic Hepatitis B Vaccine V-5 Immunitor (V5)Delivered by Oral Route
Volume: 4 Issue: 8
Author(s): Dendev Batdelger, Dorjiin Dandii, Vichai Jirathitikal and Aldar S. Bourinbaiar
Affiliation:
Keywords: Hepatitis B, Liver function test, Therapeutic vaccine, Immunomodulating supplement, per os
Abstract: 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.
Export Options
About this article
Cite this article as:
Batdelger Dendev, Dandii Dorjiin, Jirathitikal Vichai and Bourinbaiar S. Aldar, Open Label Trial of Therapeutic Hepatitis B Vaccine V-5 Immunitor (V5)Delivered by Oral Route, Letters in Drug Design & Discovery 2007; 4 (8) . https://dx.doi.org/10.2174/157018007782794545
DOI https://dx.doi.org/10.2174/157018007782794545 |
Print ISSN 1570-1808 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-628X |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Microglial Activation with Reduction in Autophagy Limits White Matter Lesions and Improves Cognitive Defects During Cerebral Hypoperfusion
Current Neurovascular Research HIV-1 gp120 and Drugs of Abuse: Interactions in the Central Nervous System
Current HIV Research The Role of Cytokine Network in the Pathophysiology of Schizophrenia
Current Psychiatry Reviews Differential Regulation of Neurotoxin in HIV Clades: Role of Cocaine and Methamphetamine
Current HIV Research Pharmacogenomics of Oral Antithrombotic Drugs
Current Pharmaceutical Design Vitamin D : Autoimmunity and Gender
Current Medicinal Chemistry A New Food-grade Coenzyme Q10 Formulation Improves Bioavailability: Single and Repeated Pharmacokinetic Studies in Healthy Volunteers
Current Drug Delivery A Novel Oromucosal Prolonged Release Mucoadhesive Suspension by One Step Spray Coagulation Method
Current Drug Delivery Combined Therapy for Gastrointestinal Carcinomas: Exploiting Synergies Between Gene Therapy and Classical Chemo-Radiotherapy
Current Gene Therapy Influence of β-D-mannuronic Acid, as a New Member of Non-steroidal Anti- Inflammatory Drugs Family, on the Expression Pattern of Chemokines and their Receptors in Rheumatoid Arthritis
Current Drug Discovery Technologies Effects of Epirubicin and Cisplatin Against 4T1 Breast Cancer Cells are Enhanced by Myrtucommulone-A
Anti-Cancer Agents in Medicinal Chemistry Assay and Dermatokinetics of Tetrahydrocurcumin Lipidic Nanostructures Using Reverse Phase-high Performance Liquid Chromatography
Pharmaceutical Nanotechnology Effect of Inhibitors of Nitric Oxide in Animal Models and Future Directions for Therapy in Inflammatory Disorders
Current Medicinal Chemistry - Anti-Inflammatory & Anti-Allergy Agents The Comprehensive Appraisal of COVID-19: Its’ Clinical Panorama from Virology till Management and Beyond
Coronaviruses Cerebral Malaria - A Neurovascular Pathology with Many Riddles Still to be Solved
Current Neurovascular Research Gut Emotions - Mechanisms of Action of Probiotics as Novel Therapeutic Targets for Depression and Anxiety Disorders
CNS & Neurological Disorders - Drug Targets New Approaches in the Diagnosis of Atherosclerosis and Treatment of Cardiovascular Disease
Recent Patents on Cardiovascular Drug Discovery The Urokinase Plasminogen Activator System: A Target for Anti-Cancer Therapy
Current Cancer Drug Targets Targeting the Multidrug ABCG2 Transporter with Flavonoidic Inhibitors: In Vitro Optimization and In Vivo Validation
Current Medicinal Chemistry Association of Serum Interleukin-34 and Insulin Resistance with Cognitive Impairment in Patients with Cerebral Small Vessel Disease
Current Neurovascular Research