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ACTIVE NOT RECRUITING
NCT05841095
PHASE1/PHASE2

Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

Official title: Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-08-04

Completion Date

2027-03-01

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DRUG

ISA104

SLP vaccine

DRUG

Placebo

Saline solution (0.9% NaCl)

Locations (1)

Erasmus MC

Rotterdam, Netherlands