Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-28 @ 1:29 AM
Study NCT ID:
NCT01353534
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2011-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2011-05-12', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate hemagglutination inhibition (HI) immune responses', 'timeFrame': 'Day 42', 'description': 'Evaluate hemagglutination inhibition (HI) immune responses to two doses of 15μg A/H5N1 achieved in the antigen plus VEP group versus the antigen alone group (Group 3 vs. Group 2) at Day 42 using standard serological parameters (Geometric Mean Titer \\[GMT\\], Geometric Mean Fold Ratio \\[GMFR\\], seroconversion and seroprotection).'}], 'secondaryOutcomes': [{'measure': 'Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP', 'timeFrame': '8 months', 'description': 'Comprehensive assessment of solicited and non-solicited local (vaccination site) and systemic adverse events (AEs) Safety follow-up through six months after last vaccination'}, {'measure': 'Characterize HI immune responses', 'timeFrame': '8 months', 'description': 'Characterize HI immune responses in the 15µg A/H5N1 antigen alone group (Group 2) and the 15µg A/H5N1 antigen plus VEP group (Group 3) to determine if levels meet or exceed EMA CPMP/BWP/214/96 criteria for immunogenicity:\n\n* The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%\n* The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%\n* GMT increase \\> 2.5'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunogenicity and Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.\n\nThe VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males or females 18-49 years of age (inclusive)\n* signed Informed Consent\n* Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and at all in-clinic visits with understanding to not become pregnant over the duration of the study.\n\nExclusion Criteria:\n\n* Clinically significant laboratory abnormalities at screening\n* abnormalities at physical examination\n* known allergies to any component of the A/H5N1 antigen\n* known egg protein allergy\n* known allergies to adhesives\n* known coagulation disorders\n* use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period\n* participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period\n* donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period\n* received or planned receipt of seasonal influenza vaccine during the study period\n* received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination\n* planned receipt of any licensed vaccine during the first 42 days on study\n* previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant\n* previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus\n* ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. Ever received cholera toxin or vaccine\n* Recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period.\n* Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period\n* Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and end-stage renal disease, as determined by the Investigator\n* positive serology for HIV-1, HIV-2, HBsAg, or HCV\n* history of severe atopy\n* medical history of acute or chronic skin disease at vaccination area\n* active skin allergy\n* signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation\n* hirsute at vaccination area\n* artificial tanning over the duration of the study including the screening period\n* visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site\n* fever greater than or equal to 38.0°C at the time of planned vaccination\n* suspicion of or recent history of alcohol or substance abuse\n* women who are pregnant or breastfeeding\n* acute illness at screening or at the time of planned vaccination\n* ever had a serious reaction to prior influenza vaccination\n* developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder\n* employee of the investigational site or sponsor\n* history of employment in bird or poultry industries or considerable exposure to birds'}, 'identificationModule': {'nctId': 'NCT01353534', 'briefTitle': 'Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercell USA, Inc.'}, 'officialTitle': 'A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults', 'orgStudyIdInfo': {'id': 'IC82-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '3.8 mcg with AS03 adjuvant at D0 and 21', 'interventionNames': ['Biological: A/H5N1 Antigen']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '15 mcg at D0 and 21', 'interventionNames': ['Biological: A/H5N1 Antigen']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '15 mcg + 50 mcg VEP at D0 and 21', 'interventionNames': ['Biological: A/H5N1 Antigen', 'Drug: Vaccine Enhancement Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': '30 mcg + 50 mcg VEP at D0', 'interventionNames': ['Biological: A/H5N1 Antigen', 'Drug: Vaccine Enhancement Patch']}], 'interventions': [{'name': 'A/H5N1 Antigen', 'type': 'BIOLOGICAL', 'description': 'A/H5N1 Antigen', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Vaccine Enhancement Patch', 'type': 'DRUG', 'description': 'Vaccine Enhancement Patch', 'armGroupLabels': ['Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Graz', 'country': 'Austria', 'facility': 'Privatklinik Leech', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2610', 'city': 'Antwerp', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University - Campus Drie Eiken', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Bernd Jilma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercell USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}