Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-04-07 @ 12:35 AM
Study NCT ID:
NCT05841095
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-21', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To study novel HBV disease markers in the study patient population to assist with treatment decisions and/or therapy response monitoring in general', 'timeFrame': '6 months', 'description': 'Levels of HBcrAg'}], 'primaryOutcomes': [{'measure': 'Safety according to AEs, SAEs', 'timeFrame': '6 months', 'description': 'AEs, SAEs'}], 'secondaryOutcomes': [{'measure': 'HBV specific Immunogenicity- following ISA104 vaccination', 'timeFrame': '6 months', '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'}, {'measure': 'Efficacy of ISA104 vaccination by using conventional biomarkers', 'timeFrame': '6 monts', 'description': 'Levels of HBsAg, HBsAb, HBeAg, HBV DNA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Therapeutic Vaccination', 'Hepatitis B cure'], 'conditions': ['Chronic Hepatitis b']}, 'descriptionModule': {'briefSummary': '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:\n\n* How safe is ISA104?\n* Does ISA104 induce immunity against hepatitis B virus?\n\nDifferent doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs.\n\nResearchers will compare the ISA104 vaccine to a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cHBV\n* Active treatment with NUCs and HBV DNA \\< limit of quantification\n\nExclusion Criteria:\n\n* Immune-compromised\n* Evidence of liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT05841095', 'acronym': 'HEB-PEP', 'briefTitle': 'Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104', 'orgStudyIdInfo': {'id': 'MEC22-0600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ISA104', 'interventionNames': ['Drug: ISA104']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ISA104', 'type': 'DRUG', 'description': 'SLP vaccine', 'armGroupLabels': ['ISA104']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline solution (0.9% NaCl)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Roel Pieterman', 'role': 'CONTACT', 'email': 'r.pieterman@erasmusmc.nl'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Roel Pieterman, MD', 'role': 'CONTACT', 'email': 'r.pieterman@erasmusmc.nl', 'phone': '0107040704'}], 'overallOfficials': [{'name': 'Dave Sprengers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ISA Pharmaceuticals B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priniciple Investigator, MD PhD', 'investigatorFullName': 'Dave Sprengers', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}