Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-31 @ 9:59 PM
Study NCT ID:
NCT02390466
Status:
UNKNOWN
Last Update Posted:
2016-06-17
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2015-01-30', 'studyFirstSubmitQcDate': '2015-03-10', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.', 'timeFrame': 'From Day 0 to week 16'}], 'secondaryOutcomes': [{'measure': 'Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.', 'timeFrame': 'From Week 16 to Week 48'}, {'measure': 'Anti-3S antibody titers', 'timeFrame': 'From Day 0 to Week 48'}, {'measure': 'Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation', 'timeFrame': 'From Day 0 to Week 48'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infected patient,\n* Age between 18 and 60 years,\n* ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,\n* Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,\n* Plasma HIV RNA ≤ 50 copies/ml at the screening visit,\n* CD4+ T cell count ≥ 200 cells/mm3,\n* Nadir CD4+ T cell count ≥ 100 cells/mm3,\n* Contraception in women with child-bearing potential,\n* A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,\n* Per protocol subject having completed the IVVAC-3S/P1 study.\n* Patient affiliated to a social security system,\n* Patient who has understood the protocol design and provided a signed written informed consent form,\n* Patient who is willing and capable of cooperating to the extent and degree required by the protocol,\n* Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.\n\nExclusion Criteria:\n\n* Administration of VAC-3S in the past year,\n* Chronic active liver disease,\n* History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,\n* Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,\n* Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,\n* Ongoing pregnancy,\n* Breastfeeding women,\n* Patient with known sensitivities to investigational drug (see please the CIB),\n* History of allergy to any vaccine,\n* Any severe chronic condition that would interfere with the study,\n* History of auto-immune disease,\n* Organ transplant,\n* Splenectomy,\n* Psychiatric disorder significant enough to hinder participation as assessed by the investigator,\n* Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).\n* Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,\n* Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.'}, 'identificationModule': {'nctId': 'NCT02390466', 'briefTitle': 'Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnaVirVax'}, 'officialTitle': 'Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1', 'orgStudyIdInfo': {'id': 'IVVAC-3S/P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VAC-3S', 'description': '32µg/ml corresponding to 16µg/vaccination', 'interventionNames': ['Biological: VAC-3S']}], 'interventions': [{'name': 'VAC-3S', 'type': 'BIOLOGICAL', 'description': 'Administered via intra-muscular injection in the arm', 'armGroupLabels': ['VAC-3S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin Saint Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Raphaël Ho Tsong Fang, DVM PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'InnaVirVax'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnaVirVax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}