Study to Evaluate the Induction of HBV Virus Neutralizing Antibodies in Healthy Vaccine Naive Adults and Non-responders and in Patients Chronically Infected With HBV Using VVX001
The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to * elicit a robust protective IgG immune response in vaccine naive subjects * in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and * in patients chronically infected with HBV.
• Cohort 1: hepatits B vaccine naive subjects Seronegative for anti-HBs and anti-HBc antibodies and for HBs Antigen
• Cohort 2: Subjects who failed to develop a protective immune response upon standard vaccination with a licensed hepatitis B vaccine (\<10 IU/L anti HbS antibodies) Seronegative for anti-HbS (\<10 IU/L) and anti-HBc antibodies and for HbSAg
• Cohort 3: Parameters confirmed at screening during the past 12 months
‣ HBeAg negative;
⁃ HbSAg positive at screening \<3000 IU/ml;
⁃ HBV viral load \<2000 IU/ml
⁃ ALT Levels ≤ULN at screening
• Cohort 4a: Parameters confirmed at screening during the last 12 months
‣ HBeAg negative;
⁃ HbSAg positive \<1000 IU/ml
⁃ HBV DNA not detectable for at least 2 years
⁃ History of nucleos(t)die Treatment for at least 3 years
⁃ Willingness to discontinue NUC treatment during study
⁃ ALT levels ≤ULN at screening
• Cohort 4b: in addition to cohort 4a:
‣ willingness to discontinue NUC treatment 6 weeks before entering the Study
⁃ ALT Levels ≤ULN 6 weeks before entering the study and
∙ 5x ULN at screening