Trials / Unknown
UnknownNCT05841095
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISA104 | SLP vaccine |
| DRUG | Placebo | Saline solution (0.9% NaCl) |
Timeline
- Start date
- 2023-08-04
- Primary completion
- 2024-09-01
- Completion
- 2025-11-01
- First posted
- 2023-05-03
- Last updated
- 2024-02-20
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05841095. Inclusion in this directory is not an endorsement.