Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
- Registration Number
- NCT05841095
- Lead Sponsor
- Erasmus Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- cHBV
- Active treatment with NUCs and HBV DNA < limit of quantification
Exclusion Criteria
- Immune-compromised
- Evidence of liver cirrhosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - ISA104 ISA104 -
- Primary Outcome Measures
Name Time Method Safety according to AEs, SAEs 6 months AEs, SAEs
- Secondary Outcome Measures
Name Time Method HBV specific Immunogenicity- following ISA104 vaccination 6 months Number of IFN-y Elispots per well after 3 day stimulation with SLPs will correspond to immunogenicity. Elispots will be performed before (baseline) and after treatment
Efficacy of ISA104 vaccination by using conventional biomarkers 6 monts Levels of HBsAg, HBsAb, HBeAg, HBV DNA
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Netherlands