Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT01502735
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2011-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2011-12-16', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with solicited adverse events (AEs) from study day 0 to 90', 'timeFrame': 'Up to 90 days'}, {'measure': 'Number of subjects with unsolicited AEs from study day 0 to 90', 'timeFrame': 'Up to 90 days'}, {'measure': 'Number of subjects who experience serious adverse events (SAEs) during the study period', 'timeFrame': 'Up to 360 Days'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4', 'timeFrame': 'Up to Day 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dengue', 'dengue fever', 'monovalent dengue vaccine'], 'conditions': ['Dengue Fever']}, 'descriptionModule': {'briefSummary': 'This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.', 'detailedDescription': 'DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.\n\nCurrently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age\n* Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses\n* Healthy\n* All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion\n* Able to provide informed consent and able to be followed throughout the trial period\n\nExclusion Criteria:\n\n* History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue\n* Have a known or suspected hypersensitivity or adverse reaction to vaccines\n* Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0\n* Are pregnant or breastfeeding\n* Known HIV, Hepatitis B and/or Hepatitis C infection\n* Have any acute illness, including an oral body temperature greater than 100.4°F at the day of vaccination\n* Have any occupational, social, or medical concerns that would impact subject safety, interfere with protocol adherence, or affect a subject's ability to give informed consent\n* Have been using immunomodulatory therapy (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) within the past 6 months; medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to the initial injection\n* Have received an investigational drug or vaccine or participated in a drug product or vaccine study within a period of 30 days prior to Day 0\n* Have received or donated blood or plasma within 90 days of Day 0 (or plan on receiving or donating blood or plasma during the study)"}, 'identificationModule': {'nctId': 'NCT01502735', 'acronym': 'DENV-1 PIV', 'briefTitle': 'Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve Adults', 'orgStudyIdInfo': {'id': 'S-10-0003'}, 'secondaryIdInfos': [{'id': 'WRAIR IRB Protocol # 1856', 'type': 'OTHER', 'domain': 'WRAIR'}, {'id': 'HSRRB Protocol #: A-17104', 'type': 'OTHER', 'domain': 'HSRRB'}, {'id': 'IND 14338', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DENV-1 PIV (high dose)', 'interventionNames': ['Biological: DENV-1 PIV, 5 µg']}, {'type': 'EXPERIMENTAL', 'label': 'DENV-1 PIV (low dose)', 'interventionNames': ['Biological: DENV-1 PIV, 2.5 µg']}], 'interventions': [{'name': 'DENV-1 PIV, 2.5 µg', 'type': 'BIOLOGICAL', 'description': '2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)', 'armGroupLabels': ['DENV-1 PIV (low dose)']}, {'name': 'DENV-1 PIV, 5 µg', 'type': 'BIOLOGICAL', 'description': '5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)', 'armGroupLabels': ['DENV-1 PIV (high dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'WRAIR, Clinical Trials Center (CTC)', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}], 'overallOfficials': [{'name': 'Stephen Thomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed Army Institute of Research (WRAIR)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}