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

Phase 2Active Not RecruitingNCT05841095

Erasmus Medical Center24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis b

Interventions

ISA104DRUG

SLP vaccine

PlaceboDRUG

Saline solution (0.9% NaCl)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * cHBV * Active treatment with NUCs and HBV DNA \< limit of quantification Exclusion Criteria: * Immune-compromised * Evidence of liver cirrhosis

Locations (1)

Erasmus MC

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Safety according to AEs, SAEs

AEs, SAEs

Time frame: 6 months

Secondary Outcomes

HBV specific Immunogenicity- following ISA104 vaccination

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

Time frame: 6 months

Efficacy of ISA104 vaccination by using conventional biomarkers

Levels of HBsAg, HBsAb, HBeAg, HBV DNA

Time frame: 6 monts

Data from ClinicalTrials.gov

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