Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-12 @ 10:50 PM
Study NCT ID:
NCT02830932
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-07-09', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.', 'timeFrame': 'Day 7', 'description': 'Number of Patients with Systemic Reactogenicity Symptoms'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.', 'timeFrame': 'Day 28', 'description': 'Number of Patients with a \\>/= 4-fold Increase in Serum Neutralizing Antibodies from Baseline as determined by PRNT Assay'}, {'measure': 'Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)', 'timeFrame': 'Days 7 and 28', 'description': 'Mean Geometric Mean Titer'}, {'measure': 'Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)', 'timeFrame': 'Days 7 and 28', 'description': 'Mean Geometric Mean Fold Rise'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus (RSV)']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers', 'detailedDescription': 'The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-RSV-f at a low dose, a high dose or placebo.\n\nTwo sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-RSV-f prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.\n\nCohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo\n\nSubjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female volunteers aged 18 - 49 years, inclusive\n2. Able to give written informed consent\n3. Healthy (no clinically significant health concerns)\n4. Safety laboratory values within the following range criteria normal range\n5. Body mass index between 17 and 35 at screening\n\nExclusion Criteria:\n\n1. Receipt of any investigational RSV vaccine within two years prior to study\n2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination\n3. Administration of any licensed vaccine within 30 days prior to study\n4. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline\n5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination\n6. Presence of a fever ≥ 38oC measured orally at baseline\n7. Stool sample with occult blood at screening'}, 'identificationModule': {'nctId': 'NCT02830932', 'briefTitle': 'Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxart'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'VXA-RSV-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VXA-RSV-f Tablets (high dose)', 'description': 'Singe dose of orally administered VXA-RSV-f Tablets (high dose). VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.', 'interventionNames': ['Biological: VXA-RSV-f Tablets (high dose)']}, {'type': 'EXPERIMENTAL', 'label': 'VXA-RSV-f Tablets (low dose)', 'description': 'Singe dose of VXA-RSV-f Tablets (low dose).VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.', 'interventionNames': ['Biological: VXA-RSV-f Tablets (low dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'VXA Placebo Tablets', 'description': 'Singe dose of matching placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.', 'interventionNames': ['Other: VXA Placebo Tablets']}], 'interventions': [{'name': 'VXA-RSV-f Tablets (high dose)', 'type': 'BIOLOGICAL', 'otherNames': ['RSV (high dose) Oral Vaccine Tablet'], 'description': 'The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.', 'armGroupLabels': ['VXA-RSV-f Tablets (high dose)']}, {'name': 'VXA Placebo Tablets', 'type': 'OTHER', 'otherNames': ['Placebo Control'], 'description': 'The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.', 'armGroupLabels': ['VXA Placebo Tablets']}, {'name': 'VXA-RSV-f Tablets (low dose)', 'type': 'BIOLOGICAL', 'otherNames': ['RSV (low dose) Oral Vaccine Tablet'], 'description': 'The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose', 'armGroupLabels': ['VXA-RSV-f Tablets (low dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32934', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Optimal Research', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data may be made available to subjects following the 1 year safety follow-up period.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vaxart', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}