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

Primary Purpose

Chronic Hepatitis b

Status
Recruiting
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
ISA104
Placebo
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b focused on measuring Immunotherapy, Therapeutic Vaccination, Hepatitis B cure

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ISA104

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety according to AEs, SAEs
AEs, SAEs

Secondary Outcome Measures

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
Efficacy of ISA104 vaccination by using conventional biomarkers
Levels of HBsAg, HBsAb, HBeAg, HBV DNA

Full Information

First Posted
March 27, 2023
Last Updated
August 10, 2023
Sponsor
Erasmus Medical Center
Collaborators
ISA Pharmaceuticals B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05841095
Brief Title
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
ISA Pharmaceuticals B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
Immunotherapy, Therapeutic Vaccination, Hepatitis B cure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISA104
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ISA104
Intervention Description
SLP vaccine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline solution (0.9% NaCl)
Primary Outcome Measure Information:
Title
Safety according to AEs, SAEs
Description
AEs, SAEs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HBV specific Immunogenicity- following ISA104 vaccination
Description
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
Title
Efficacy of ISA104 vaccination by using conventional biomarkers
Description
Levels of HBsAg, HBsAb, HBeAg, HBV DNA
Time Frame
6 monts
Other Pre-specified Outcome Measures:
Title
To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general
Description
Levels of HBcrAg
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cHBV Active treatment with NUCs and HBV DNA < limit of quantification Exclusion Criteria: Immune-compromised Evidence of liver cirrhosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roel Pieterman, MD
Phone
0107040704
Email
r.pieterman@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Sprengers, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roel Pieterman
Email
r.pieterman@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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