Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT05972733
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aborkowski@hillevax.com', 'phone': '+1 (617) 213-6562', 'title': 'Astrid Borkowski, Chief Medical Officer', 'organization': 'HilleVax, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events, all-cause mortality and other significant adverse events were assessed for each participant from Day 1 to Day 85', 'description': 'Solicited AE (local and systemic) data was collected for 79 participants.', 'eventGroups': [{'id': 'EG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 80, 'otherNumAffected': 52, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 35}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Immunogenicity for Panel Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'classes': [{'title': 'Anti-GI.1 HBGA-blocking seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '77.4', 'upperLimit': '93.6'}]}]}, {'title': 'Anti-GII.4c HBGA-blocking seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '82.3'}]}]}, {'title': 'Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '71.6'}]}]}, {'title': 'Anti-GI.1 pan-Ig seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100'}]}]}, {'title': 'Anti-GII.4c pan-Ig seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '96.3'}]}]}, {'title': 'Anti-GI.1 and GII.4c pan-Ig seroresponse rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 29', 'description': 'Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants that received trial vaccine (HIL-214).'}, {'type': 'SECONDARY', 'title': 'Adverse Events Leading to Participant Withdrawal From the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 85', 'description': 'Adverse events leading to trial withdrawal were collected throughout the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants that received trial vaccine (HIL-214).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 7', 'description': 'Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants who received trial vaccine (HIL-214).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 7', 'description': 'Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants who received trial vaccine (HIL-214).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 28', 'description': 'Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the trial at 2 investigative sites in the United States from 01 August 2023 to 10 November 2023.', 'preAssignmentDetails': 'Healthy volunteers were enrolled in 1 treatment arm and received a single dose of HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIL-214', 'description': 'One dose of norovirus GI.1/GII.4c bivalent virus-like particle (VLP) vaccine (HIL-214) (50 µg of GI.1 VLP and 150 µg GII.4c VLP, adjuvanted with 500 µg aluminum hydroxide) by intramuscular injection on Day 1.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '9.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.32', 'spread': '24.573', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.70', 'spread': '10.822', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.06', 'spread': '8.358', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set, all participants that received trial vaccine (HIL-214).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-25', 'size': 1988193, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-28T15:38', 'hasProtocol': True}, {'date': '2024-01-12', 'size': 10331977, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-28T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, Open-label Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2023-07-11', 'resultsFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-31', 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Immunogenicity for Panel Formation', 'timeFrame': 'Day 1 to Day 29', 'description': 'Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events Leading to Participant Withdrawal From the Trial', 'timeFrame': 'Day 1 to Day 85', 'description': 'Adverse events leading to trial withdrawal were collected throughout the trial.'}, {'measure': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration', 'timeFrame': 'Day 1 to Day 7', 'description': 'Assessed solicited local AEs included pain at injection site, redness, swelling, and induration. See AE tables for specifics.'}, {'measure': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration', 'timeFrame': 'Day 1 to Day 7', 'description': 'Assessed solicited systemic AEs included headache, fatigue, myalgia, arthralgia, vomiting, diarrhea, and fever.'}, {'measure': 'Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine', 'timeFrame': 'Day 1 to Day 28', 'description': 'Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.', 'detailedDescription': 'This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects aged 18 to 49 years, inclusive.\n* Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.\n* The individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.\n* Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.\n\nExclusion Criteria:\n\n* Females who are pregnant or breastfeeding.\n* Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).\n* Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).\n* Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.\n* Any serious chronic or progressive disease (including hepatitis B or C).\n* Previous exposure to an experimental norovirus vaccine.\n* Subject or subject's first-degree relatives are involved in the trial conduct."}, 'identificationModule': {'nctId': 'NCT05972733', 'briefTitle': 'Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'HilleVax'}, 'officialTitle': 'Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years', 'orgStudyIdInfo': {'id': 'NOR-215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Arm Study', 'description': 'One dose given to all participants', 'interventionNames': ['Biological: HIL-214']}], 'interventions': [{'name': 'HIL-214', 'type': 'BIOLOGICAL', 'description': 'HIL-214', 'armGroupLabels': ['Open Arm Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Pennisula Research Associates', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HilleVax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}