Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-26 @ 1:05 AM
Study NCT ID:
NCT02200718
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2014-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508473', 'term': 'NeuroVax vaccine'}, {'id': 'C098825', 'term': "HIV-1 immunogen, incomplete Freund's adjuvant"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2024-11-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups', 'timeFrame': '26 Weeks', 'description': 'The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI \\& to compare the increases of WBC white blood cell counts in subjects in the treatment groups with Pediatric MS'}], 'secondaryOutcomes': [{'measure': 'A Secondary clinical endpoint is the measurement of FOXP3+ expression', 'timeFrame': '26 Weeks', 'description': 'Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups'}, {'measure': 'A Secondary clinical endpoint is the measurment of EDSS scores', 'timeFrame': '26 Weeks', 'description': 'To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 \\& 26 visit then exit the study.'}, {'measure': 'A Secondary clinical endpoint is the measurement of clinical relapses', 'timeFrame': '26 Weeks', 'description': 'To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis Pediatric MS NeuroVax Vaccine Therapeutic'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \\& efficacy', 'detailedDescription': 'A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \\& efficacy 12 subjects with pediatric MS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages Eligible for Study: 5 Years to 17 Years\n* Genders Eligible for Study: Both\n* Accepts Healthy Volunteers: No Criteria\n* Subject is between 5 and 17 years of age, inclusive\n* Clinically diagnosed Pediatric MS\n* Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a pediatric MS course\n* Expanded Disability Status Scale (EDSS) \\<= score 6.5 (Appendix B) Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 12 months prior to screening\n* Laboratory values within the following limits:\n\n * Creatinine 1 . 5 x high normal\n * Hemoglobin\n\nExclusion Criteria:\n\n* Subjects currently prescribed Campath or Lemtrada'}, 'identificationModule': {'nctId': 'NCT02200718', 'briefTitle': 'A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immune Response BioPharma, Inc.'}, 'officialTitle': 'A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'IR902-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeuroVax', 'description': "NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA V Beta Peptides BV5S2, BV6S5 and BV13S1 emulsified in incomplete Freund's adjuvant", 'interventionNames': ['Biological: NeuroVax']}, {'type': 'PLACEBO_COMPARATOR', 'label': "IFA Incomplete Freund's Adjuvant", 'description': "IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil a surfactant system designed to make a water-in-oil emulsion", 'interventionNames': ["Biological: IFA Incomplete Freund's Adjuvant"]}], 'interventions': [{'name': 'NeuroVax', 'type': 'BIOLOGICAL', 'otherNames': ['IR902 TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1'], 'description': 'NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1', 'armGroupLabels': ['NeuroVax']}, {'name': "IFA Incomplete Freund's Adjuvant", 'type': 'BIOLOGICAL', 'description': "IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion", 'armGroupLabels': ["IFA Incomplete Freund's Adjuvant"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '92129', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Richard M Bartholomew, PhD', 'role': 'CONTACT', 'email': 'Richardmbartholomew@gmail.com', 'phone': '858-414-4664'}], 'facility': 'CRO', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Richard M Bartholomew, Ph.D', 'role': 'CONTACT', 'email': 'Richardmbartholomew@gmail.com', 'phone': '1-858-414-4664'}], 'overallOfficials': [{'name': 'Richard M Bartholomew, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Immune Response BioPharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immune Response BioPharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}