Overview
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-11-01
2025-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question[s] it aims to answer are: - How safe is ISA104? - Does ISA104 induce immunity against hepatitis B virus? Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs. Researchers will compare the ISA104 vaccine to a placebo.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Erasmus Medical CenterCollaborator:
ISA Pharmaceuticals B.V.
Criteria
Inclusion Criteria:- cHBV
- Active treatment with NUCs and HBV DNA < limit of quantification
Exclusion Criteria:
- Immune-compromised
- Evidence of liver cirrhosis