Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B

Inclusion Criteria:

• Male or female subject between 18 and 65 years of age at the time of randomization.

• Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior toscreening and at screening.

• Has HBV DNA < 40 IU/mL for at least 1 year prior to screening and at screening

• Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and atscreening.

• Must be HBsAg positive at screening.

• Has been treated with NUCs for at least 2 years prior to screening.

• Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.

• For all females, must have a negative serum pregnancy test at screening. For female ofchildbearing potential, must have been using adequate contraception and must agree tocontinue to use it during all study period and for 6 months after completion of thestudy product administration.

• Has provided written informed consent.

Exclusion Criteria:

• Has elevated blood levels of alpha-fetoprotein (AFP) (> 500 ng/mL).

• Has cirrhosis, defined as

• platelet count < 150,000/mm3, with esophageal varices on imaging and spleen size > 12, or

• liver stiffness of 11 kilopascal [kPa] as measured by elastography usingFibroScan® or .an AST to Platelet Ratio Index (APRI) > 2).

• Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).

• Has liver decompensation (albumin < 3.5 g/dL and bilirubin ≥1.3 mg/dL).

• Is Hepatitis C virus (HCV) Ab positive at screening.

• Is Hepatitis delta virus (HDV) Ab positive at screening.

• Is Human Immunodeficiency Virus (HIV) Ab positive at screening.

• Has an immune suppressive disorder or treatment with immunosuppressive drugs.

• Has been treated with corticosteroids within 12 weeks prior to the firstadministration of study product, with the exception of topical or inhaledcorticosteroids.

• Has been treated with rituximab.

• Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxichepatitis, Wilson disease, alcoholic or hemochromatosis).

• Has a history of allergic disease or reactions likely to be exacerbated by anycomponent of the study products.

• Has a history of a substance abuse (drug or alcohol) problem within the previous 3years.