Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104 (HEB-PEP)

February 16, 2024 updated by: Dave Sprengers, Erasmus Medical Center

Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Immune-compromised
  • Evidence of liver cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Saline solution (0.9% NaCl)
Active Comparator: ISA104
Drug: ISA104
SLP vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety according to AEs, SAEs
Time Frame: 6 months
AEs, SAEs
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Efficacy of ISA104 vaccination by using conventional biomarkers
Time Frame: 6 monts
Levels of HBsAg, HBsAb, HBeAg, HBV DNA
6 monts

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

ISA Pharmaceuticals B.V.

Investigators

  • Principal Investigator: Dave Sprengers, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC22-0600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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