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NCT05841095 Clinical Trial

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

Chronic Hepatitis b Clinical Trial

— HEB-PEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05841095
Other study ID # MEC22-0600
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 4, 2023
Est. completion date November 1, 2025

Study information
Verified date February 2024
Source Erasmus Medical Center
Contact Roel Pieterman, MD
Phone 0107040704
Email r.pieterman@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date November 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - cHBV - Active treatment with NUCs and HBV DNA < limit of quantification Exclusion Criteria: - Immune-compromised - Evidence of liver cirrhosis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ISA104
SLP vaccine
• Placebo
Saline solution (0.9% NaCl)

Locations
Country Name City State
Netherlands Erasmus MC Rotterdam

Sponsors (2)
Lead Sponsor Collaborator
Erasmus Medical Center ISA Pharmaceuticals B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Other To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general Levels of HBcrAg 6 months
Primary Safety according to AEs, SAEs AEs, SAEs 6 months
Secondary 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 6 months
Secondary Efficacy of ISA104 vaccination by using conventional biomarkers Levels of HBsAg, HBsAb, HBeAg, HBV DNA 6 monts
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