Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-27 @ 11:48 AM
Study NCT ID:
NCT06002503
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with immediate reactions', 'timeFrame': '30 minutes after each vaccination', 'description': 'The nature, frequency, and severity of immediate reactions following vaccination'}, {'measure': 'Solicited adverse events', 'timeFrame': '7 days after each vaccination', 'description': 'The nature, frequency, and severity of solicited adverse events'}, {'measure': 'Unsolicited adverse events', 'timeFrame': '28 days after the final vaccination', 'description': 'The nature, frequency, and severity of unsolicited adverse events'}, {'measure': 'Adverse events', 'timeFrame': '1 year', 'description': 'The nature, frequency, and severity of adverse events'}], 'secondaryOutcomes': [{'measure': 'VEEV-specific antibody', 'timeFrame': '1 year', 'description': 'PsVNA50'}, {'measure': 'Seroconversion rate', 'timeFrame': '1 year', 'description': 'PsVNA50'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vaccine Reaction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is:\n\n• Is the VEE DNA Vaccine candidate safe\n\nParticipants will:\n\n* Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection\n* Provide blood and urine samples\n* Complete ECGs\n* Complete physical exams\n* Complete diaries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults, male or female.\n* Ages at least 18 at the start of the study and no greater than 49 years of age on Day 1 of vaccination.\n* Participants must be available for all visits and for the complete duration of the study.\n* Participants must, in the opinion of the Investigator or person obtaining consent, understand the information provided and be capable of providing informed consent.\n* Women of child bearing potential (WOCBP) must have a negative pregnancy test and be willing to use an effective method of contraception: oral contraception, diaphragm, cervical cap, intrauterine device, condom, or be anatomically sterile (in self or partner) from the date of screening until at least 6 months after the last vaccination.\n* If subject is a sexually active male, must be willing to use an effective method of contraception (such as condoms or be anatomically sterile) from screening until 6 months after the last vaccination.\n\nExclusion Criteria:\n\n* Clinically relevant abnormality on history or examination including a history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered to be significant by the designated trial physician in the last 6 months.\n* Any acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the Investigator, would preclude participation.\n* Any of the following laboratory parameters with abnormal values that are moderate in severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, AST, ALT).\n* If female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination.\n* Receipt of a blood transfusion or blood products 6 months prior to enrollment.\n* Participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study.\n* History of severe local or systemic reactions to vaccination or a history of severe allergic reactions.\n* History of Guillain-Barre syndrome.\n* Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C infection (HCV Ab positive); HIV infection, or active syphilis.\n* History of grand mal epilepsy, or currently taking anti-epileptics.\n* Any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection.\n* Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject from participating.\n* History of syncope or history of a fainting episode within one year of study entry.\n* Extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles).\n* Presence of any surgical/traumatic metal implants, or significant scar tissue that may impair appropriate injection at the eligible sites of administration (skin or muscle of the upper left and right deltoid muscles).\n* In the opinion of the Investigator, is unlikely to comply with the protocol.\n* As confirmed/reported by the study subject, a history of: exposure to Venezuelan Equine Encephalitis Virus (VEEV) or related alphavirus; prior immunization with an alphavirus replicon-based vaccine; prior immunization with a live-attenuated alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine.\n* A history of encephalitis as confirmed/reported by the study subject.\n* Prior immunization against VEEV or related alphavirus or encephalitis, as confirmed/reported by the study subject.\n* History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse (excluding marijuana) or addiction within 12 months of screening.\n* Involved in the planning or conduct of the study.'}, 'identificationModule': {'nctId': 'NCT06002503', 'briefTitle': 'Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered by Jet Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaJet, Inc.'}, 'officialTitle': 'A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults', 'orgStudyIdInfo': {'id': 'VEEV-PJ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Intramuscular', 'description': 'Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26', 'interventionNames': ['Drug: Venezuelan Equine Encephalitis DNA Vaccine', 'Device: PharmaJet Stratis Needle-free Injection System']}, {'type': 'EXPERIMENTAL', 'label': '2: Intramuscular', 'description': 'Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4', 'interventionNames': ['Drug: Venezuelan Equine Encephalitis DNA Vaccine', 'Device: PharmaJet Stratis Needle-free Injection System']}, {'type': 'EXPERIMENTAL', 'label': '3: Intradermal', 'description': 'Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26', 'interventionNames': ['Drug: Venezuelan Equine Encephalitis DNA Vaccine', 'Device: PharmaJet Tropis Needle-free Injection System']}, {'type': 'EXPERIMENTAL', 'label': '4: Intradermal', 'description': 'Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4', 'interventionNames': ['Drug: Venezuelan Equine Encephalitis DNA Vaccine', 'Device: PharmaJet Tropis Needle-free Injection System']}], 'interventions': [{'name': 'Venezuelan Equine Encephalitis DNA Vaccine', 'type': 'DRUG', 'description': 'Venezuelan Equine Encephalitis DNA Vaccine Candidate', 'armGroupLabels': ['1: Intramuscular', '2: Intramuscular', '3: Intradermal', '4: Intradermal']}, {'name': 'PharmaJet Stratis Needle-free Injection System', 'type': 'DEVICE', 'description': 'Intramuscular Needle-free Injection System (Jet Injector)', 'armGroupLabels': ['1: Intramuscular', '2: Intramuscular']}, {'name': 'PharmaJet Tropis Needle-free Injection System', 'type': 'DEVICE', 'description': 'Intradermal Needle-free Injection System (Jet Injector)', 'armGroupLabels': ['3: Intradermal', '4: Intradermal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaJet, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}