A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection

Launched by VAXINE PTY LTD · Jan 31, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine designed to help manage or potentially cure chronic Hepatitis B virus (HBV) infection. The goal is to see if this vaccine can safely control the virus and help the immune system create a response against it, particularly for people who haven’t responded well to standard treatments. While the vaccine has shown promise in early tests for preventing Hepatitis B, this trial will focus on its effects in individuals who are already living with chronic HBV.

To participate, you must be at least 18 years old and currently diagnosed with chronic Hepatitis B, which means the virus is still present in your body. Participants should be able to give informed consent and follow the study rules. However, if you have certain conditions, such as other serious liver diseases or are pregnant, you may not be eligible. If you join the trial, you can expect to receive the vaccine and be monitored for safety and effectiveness over the study period. This could be an important step toward improving treatment options for people with chronic Hepatitis B.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female
• • 18 years of age or older
• • Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by detection of HBsAg and/or Hepatitis B DNA (Subjects on current nucleoside therapy may have no detectable Hep B DNA)
• • If child bearing age, using contraception (barrier method, IUD or oral contraception)
• • Able to provide written informed consent
• • Willing and able to comply with the protocol for the duration of the study.
• Exclusion Criteria:
• • Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results for the rest of the HBV markers, indicating acute infection,
• • Positive for anti-delta virus, or anti-hepatitis C virus or HIV
• • Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater
• • Liver transaminases greater than 5 times the upper limit of normal
• • History of severe allergic reaction to hepatitis B vaccine.
• • Pregnancy or female of child-bearing age not using effective method of contraception.
• • Presence of any other organ-specific disease that in the opinion of the investigator may result in risk to the subject from involvement in the study
• • Current alcohol or drug abuse that in the opinion of the investigator may result in non-compliance.
• • Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment