Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-27 @ 6:29 AM
Study NCT ID:
NCT01702857
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}, {'id': 'D019595', 'term': 'Severe 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D000536', 'term': 'Aluminum Hydroxide'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and reactogenicity of various TDENV-PIV formulations from Day 0 through 28 days after the second dose (Day 0 - Day 56)', 'timeFrame': 'Up to Day 56', 'description': 'Safety and Reactogenicity:\n\n* Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) during the 7-day follow-up period post each vaccination (Day 0-6)\n* Occurrence, intensity and relationship to vaccination of unsolicited AEs during the 28-day follow-up period post each vaccination (Day 0-27)\n* Hematological and biochemical levels at study visits on Days 0, 7, 28, 35 and 56\n* Occurrence of serious adverse events (SAEs) from Day 0 to Day 56\n* Occurrence of potential immune-mediated diseases (pIMDs) and medically attended AEs from Day 0 to Day 56'}, {'measure': 'Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations 28 days after the second dose (Day 56)', 'timeFrame': 'Day 56', 'description': 'Humoral Immunogenicity:\n\nNeutralizing antibody titers specific to each DENV type at Day 56\n\n* Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type\n* Rate of fold increases in neutralizing antibody from Day 0 for each DENV type\n* Seropositivity rates for each DENV type\n* Trivalent and tetravalent seropositivity rates'}], 'secondaryOutcomes': [{'measure': 'Safety of various TDENV-PIV formulations, from Day 0 to Month 13 (Visits 1-11)', 'timeFrame': 'Up to month 13', 'description': 'Safety:\n\n* Hematological and biochemical levels at study visits on Months 4, 7, 10 and Month 13\n* Occurrence of pIMDs and medically attended AEs from Day 0 to Month 13\n* Occurrence of any SAE from Day 0 to Month 13'}, {'measure': 'Humoral immunogenicity to each of four DENV types of various TDENV-PIV formulations on Days 0, 7 and 28 and Months 7 and 13', 'timeFrame': 'Up to month 13', 'description': 'Humoral Immunogenicity:\n\n* Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type\n* Rate of fold increases in neutralizing antibody from Day 0 for each DENV type\n* Seropositivity rates for each DENV type\n* Trivalent and tetravalent seropositivity rates'}, {'measure': '• To evaluate the safety of various TDENV-PIV formulations from Month 14 through the end of the study (Visit 15)', 'timeFrame': 'Up to the end of study (Month 37-39)', 'description': 'Occurrence of serious adverse events (SAEs) related to study procedures from Month 14 to end of study (Month 37-39)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dengue', 'Dengue fever', 'Dengue Hemorrhagic Fever', 'Flavivirus'], 'conditions': ['Dengue Fever']}, 'referencesModule': {'references': [{'pmid': '29512481', 'type': 'DERIVED', 'citation': 'Diaz C, Lin L, Martinez LJ, Eckels KH, Campos M, Jarman RG, De La Barrera R, Lepine E, Toussaint JF, Febo I, Innis BL, Thomas SJ, Schmidt AC. Phase I Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico. Am J Trop Med Hyg. 2018 May;98(5):1435-1443. doi: 10.4269/ajtmh.17-0627. Epub 2018 Mar 1.'}]}, 'descriptionModule': {'briefSummary': "This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV vaccine in a predominantly dengue-primed adult population. The study is designed to afford a first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of the four DENV types. The control group will receive a saline placebo. All experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart. There is a parallel FTiH study that is conducted in the United States in a dengue-naive population using the same investigational vaccines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.)\n* A male or female between 20 and 39 years of age (inclusive) at the time of consent\n* Written informed consent obtained from the subject\n* Healthy subjects as established by medical history and clinical examination before entering into the study\n* Subject has lived in the Caribbean for more than 10 years\n* Female subjects of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least three months prior to enrollment, hysterectomy, ovariectomy, or is post-menopause).\n* Female subjects of childbearing potential may be enrolled in the study, if the subject has:\n\n * practiced adequate contraception for 30 days prior to vaccination, and\n * a negative urine pregnancy test on the day of vaccination, and\n * agreed to continue adequate contraception until two months after completion of the vaccination series\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)\n* Planned administration or administration of a vaccine/product not foreseen by the study protocol during the Exclusion:\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent; inhaled and topical steroids are allowed)\n* Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until after the visit at Day 56 (if influenza activity warrants vaccination of healthy young adults, influenza vaccination will be encouraged and will not lead to study exclusion)\n* Previous or planned administration of any other flavivirus vaccine (approved or investigational) for the entire study duration\n* Previous receipt of any investigational dengue virus vaccine\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* Family history of congenital or hereditary immunodeficiency\n* History of, or current auto-immune disease\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/placebo or related to a study procedure\n* Major congenital defects or serious chronic illness\n* History of any neurological disorders or seizures\n* Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment (a subject with a minor illness, i.e., mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator)\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests\n* Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period\n* History of chronic alcohol consumption and/or drug abuse\n* Pregnant or lactating female or female planning to become pregnant or planning to discontinue contraceptive precautions\n* A planned move to a location that will prohibit participating in the trial until study end for the participant\n* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.\n* Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)\n* Safety laboratory test results that are outside the normal limits for their age, gender, and locality at screening.'}, 'identificationModule': {'nctId': 'NCT01702857', 'acronym': 'DPIV-002', 'briefTitle': 'A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'A Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of WRAIR Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in Puerto Rico', 'orgStudyIdInfo': {'id': 'S-12-12'}, 'secondaryIdInfos': [{'id': '116614', 'type': 'OTHER', 'domain': 'GSK'}, {'id': 'WRAIR 1945', 'type': 'OTHER', 'domain': 'WRAIR'}, {'id': 'DPIV-002', 'type': 'OTHER', 'domain': 'GSK Protocol #'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TDENV-PIV alum4', 'description': '4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days', 'interventionNames': ['Biological: Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'TDENV-PIV AS03B', 'description': '1 µg TDENV-PIV with AS03B adjuvant; 0.5 mL intramuscular injection at 0 and 28 days', 'interventionNames': ['Biological: Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days', 'interventionNames': ['Other: Phosphate buffered saline']}, {'type': 'EXPERIMENTAL', 'label': 'TDENV-PIV alum1', 'description': '1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days', 'interventionNames': ['Biological: 1 µg TDENV-PIV with Alum adjuvant']}, {'type': 'EXPERIMENTAL', 'label': 'TDENV-PIV AS01E', 'description': '1 µg TDENV-PIV with AS01E adjuvant; 0.5 mL intramuscular injection at 0 and 28 days', 'interventionNames': ['Biological: 1 µg TDENV-PIV with AS01E adjuvant']}], 'interventions': [{'name': 'Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TDENV-PIV alum4']}, {'name': 'Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TDENV-PIV AS03B']}, {'name': 'Phosphate buffered saline', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}, {'name': '1 µg TDENV-PIV with Alum adjuvant', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TDENV-PIV alum1']}, {'name': '1 µg TDENV-PIV with AS01E adjuvant', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TDENV-PIV AS01E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Clinical Research Center, 1st Floor University Hospital', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Clemente Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Puerto Rico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}