A Study to Assess DV-601 in Subjects With Chronic Hepatitis B

A Phase Ib Dose-Escalation Study to Assess the Safety and Tolerability of DV-601 in Subjects With Chronic Hepatitis B on Concurrent Treatment With a Nucleoside Analogue

The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.

Inclusion Criteria:

• Male and female subjects 18 to 65 years of age.
• Signed informed consent.
• Diagnosis of CHB and candidates for therapy
• Normal renal function
• Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.

Exclusion Criteria:

• Liver disease other than CHB
• Documented co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), or HIV
• Previous therapy with interferon alpha.
• Any other antiviral therapy for chronic hepatitis B within the previous 3 months prior to Screening Visit.
• Immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of Screening Visit.
• Evidence of cirrhosis
• Child-Turcotte-Pugh (CTP) score ≥ 7, either currently or at any occasion in the past
• Clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
• Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
• Participation in any experimental protocol or therapy within 28 days prior to the Screening Visit.
• Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.