Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05841095

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Erasmus MC

Rotterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cHBV
  • Active treatment with NUCs and HBV DNA < limit of quantification

Exclusion criteria

  • Immune-compromised
  • Evidence of liver cirrhosis

Treatment and study plan

ISA104

Drug

SLP vaccine

Placebo

Drug

Saline solution (0.9% NaCl)

Primary outcomes

  1. Safety according to AEs, SAEs

    Time frame: 6 months

    AEs, SAEs

Secondary outcomes

  1. HBV specific Immunogenicity- following ISA104 vaccination

    Time frame: 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

  2. Efficacy of ISA104 vaccination by using conventional biomarkers

    Time frame: 6 monts

    Levels of HBsAg, HBsAb, HBeAg, HBV DNA

Other outcomes

  1. To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general

    Time frame: 6 months

    Levels of HBcrAg

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • ISA Pharmaceuticals B.V.

Registry information

Official study title

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

Acronym: HEB-PEP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 3, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.