Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
HEB-PEP
Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedStudy Start
First participant enrolled
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedFebruary 20, 2024
February 1, 2024
1.1 years
March 27, 2023
February 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety according to AEs, SAEs
AEs, SAEs
6 months
Secondary Outcomes (2)
HBV specific Immunogenicity- following ISA104 vaccination
6 months
Efficacy of ISA104 vaccination by using conventional biomarkers
6 monts
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
6 months
Study Arms (2)
ISA104
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- cHBV
- Active treatment with NUCs and HBV DNA \< limit of quantification
You may not qualify if:
- Immune-compromised
- Evidence of liver cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- ISA Pharmaceuticals B.V.collaborator
Study Sites (1)
Erasmus MC
Rotterdam, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Sprengers, MD, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priniciple Investigator, MD PhD
Study Record Dates
First Submitted
March 27, 2023
First Posted
May 3, 2023
Study Start
August 4, 2023
Primary Completion
September 1, 2024
Study Completion
November 1, 2025
Last Updated
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share