None listed
Conditions
Brief summary
GS-4774 is an experimental (investigational) vaccine being tested as a possible treatment of chronic Hepatitis B and is not yet approved by the United States Food and Drug Administration (FDA). GS-4774 has been designed to stimulate your immune system, the system that your body uses to defend itself from infections. GS-4774 is produced from “baker’s yeast” which has been changed to include the substance found in the Hepatitis B virus. This yeast has been heat inactivated and you will not be receiving live yeast. Studies in healthy subjects have shown that GS-4774 stimulated the immune system to help block the spread of Hepatitis B virus. The purpose of this study is to determine how well your body tolerates GS-4774 and how it affects the HBV infection in your body in addition to the oral antiviral treatment regimen you are currently receiving. The study is for research purposes only and is not intended or expected to cure any medical conditions. As this is a research study, GS-4774 will only be given to you during your participation of the trial.
Interventions
Treatment Arm A: 25 subjects continue Oral Antiviral alone
Treatment Arm B: 50 subjects OAV + GS-4774 2 YU (Yeast Units)subcutaneous injection every four weeks for 6 doses
Treatment Arm C: 50 subjects OAV + GS-4774 10 YU
subcutaneous injection every four weeks for 6 doses
Treatment Arm D: 50 subjects OAV + GS-4774 40 YU
subcutaneous injection every four weeks for 6 doses
a) the dose of GS-4774 administered is GS 4774 2YU (Yeast Units) or 10YU or 40YU or Oral antiviral alone
b) Administered every
Treatment Arm A: 25 subjects continue Oral Antiviral alone Treatment Arm B: 50 subjects OAV + GS-4774 2 YU (Yeast Units)subcutaneous injection every four weeks for 6 doses Treatment Arm C: 50 subjects OAV + GS-4774 10 YU subcutaneous injection every four weeks for 6 doses Treatment Arm D: 50 subjects OAV + GS-4774 40 YU subcutaneous injection every four weeks for 6 doses a) the dose of GS-4774 administered is GS 4774 2YU (Yeast Units) or 10YU or 40YU or Oral antiviral alone b) Administered every 4 weeks for 6 doses c) Mode of administration, Oral antirvial and GS 4774 subcutaneous injection d) We will be collecting patient reported adherence to OAV at each study visit on the Electronic Data Base.
Sponsors
Gilead Sciences, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Documented evidence of chronic HBV infection (e.g., HBsAg positive for more than 6 months) 2. Virally-suppressed (screening HBV DNA <29 IU/mL) with HBV DNA below the lower limit of quantification 3. Ability to understand and sign a writtent informed consent form, which must be obtained prior to initiation of study procedures 4. Currently taking an HBV oral antiviral medication
Exclusion criteria
1. Cirrhosis 2. Co-infection with HCV, HIV or HDV 3. Evidence of hepatocellular carcinoma (e.g., as evidenced by recent imaging) 4. Significant cardiovascular, pulmonary, or neurological disease 5. Received solid organ or bone marrow transplant 6. Received prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal Ab, interferon) within 3 months of screening 7. Use of another investigational agents within 3 months of screening 8. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance 9. Receipt of immunoglobulin or other blood products within 3 months of screening 10. Known hypersensitivity to study drug, metabolites or formulation excipients
Outcome results
None listed