Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
NCT ID: NCT05841095
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2023-08-04
2025-11-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISA104
ISA104
SLP vaccine
Placebo
Placebo
Saline solution (0.9% NaCl)
Interventions
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ISA104
SLP vaccine
Placebo
Saline solution (0.9% NaCl)
Eligibility Criteria
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Inclusion Criteria
* Active treatment with NUCs and HBV DNA \< limit of quantification
Exclusion Criteria
* Evidence of liver cirrhosis
18 Years
55 Years
ALL
No
Sponsors
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ISA Pharmaceuticals B.V.
INDUSTRY
Erasmus Medical Center
OTHER
Responsible Party
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Dave Sprengers
Priniciple Investigator, MD PhD
Principal Investigators
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Dave Sprengers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEC22-0600
Identifier Type: -
Identifier Source: org_study_id
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