Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06077656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-12', 'releaseDate': '2025-08-26'}, {'resetDate': '2025-12-01', 'releaseDate': '2025-11-17'}], 'estimatedResultsFirstSubmitDate': '2025-08-26'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25 in which healthy adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-05-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Solicited local adverse events (AEs)', 'timeFrame': '7 days post-vaccination (Day 8)', 'description': 'Number and severity of solicited local AEs'}, {'measure': 'Solicited systemic AEs', 'timeFrame': '7 days post-vaccination (Day 8)', 'description': 'Number and severity of solicited systemic AEs'}, {'measure': 'Unsolicited AEs', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'Number and severity of unsolicited AEs'}, {'measure': 'Severe adverse events (SAEs)', 'timeFrame': '6 months post-vaccination (Day 169)', 'description': 'Number of SAEs'}], 'secondaryOutcomes': [{'measure': 'Immunoglobulin G (IgG) geometric mean concentration (GMC)', 'timeFrame': 'Baseline (Day 1) and 28 days post-vaccination (Day 29)', 'description': 'Serotype-specific IgG GMCs'}, {'measure': 'IgG geometric mean fold rise (GMFR)', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'IgG GMFR as measured by serotype-specific IgG GMCs from baseline'}, {'measure': 'IgG four-fold rise', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'Percentage of participants with four-fold IgG GMC rise or greater as measured by serotype-specific IgG GMCs from baseline'}, {'measure': 'IgG GMC ratio', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'IgG GMC ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs'}, {'measure': 'IgG GMFR ratio', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'IgG GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific IgG GMCs'}, {'measure': 'OPA geometric mean titer (GMT)', 'timeFrame': 'Baseline (Day 1) and 28 days post-vaccination (Day 29)', 'description': 'Serotype-specific OPA GMTs'}, {'measure': 'OPA GMFR', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'OPA GMFR between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs from baseline'}, {'measure': 'OPA GMT ratio', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'OPA GMT ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs'}, {'measure': 'OPA GMFR ratio', 'timeFrame': '28 days post-vaccination (Day 29)', 'description': 'OPA GMFR ratio between IVT PCV-25 and Prevnar 20 groups as measured by serotype-specific OPA GMTs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Vaccines']}, 'descriptionModule': {'briefSummary': "Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)", 'detailedDescription': 'A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults who are 18 through 49 years old on the day of randomization (Day 1).\n* Participant must provide voluntary written informed consent to participate in the study.\n* Participant must be able to comprehend and comply with study requirements and procedures and be willing and able to return for all scheduled follow-up visits.\n* Adult female participants who are not surgically sterile must have a negative pregnancy test at screening and negative pregnancy test prior to vaccination and must agree to employ a highly effective method to avoid pregnancy through Day 57 of the study.\n\nExclusion Criteria:\n\n* Use of any investigational medicinal product within 90 days prior to randomization or planned use of such a product during the period of study participation.\n* Adults who have previously been vaccinated against S. pneumoniae.\n* History of microbiologically confirmed invasive disease caused by S. pneumoniae.\n* History of allergic disease (including angioedema) or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines, including PEG.\n* Any abnormal vital sign deemed clinically relevant by the PI.\n* Acute illness at time of randomization (moderate or severe) and/or fever (body temperature of ≥ 38.0°C)\n* History of any non-study vaccine administration within 14 days of study vaccine administration.\n* No planned vaccines until after Day 29 (Visit 3).\n* Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine (and within the 6 months prior to administration of the study vaccine), including the use of glucocorticoids. The use of topical and inhaled glucocorticoids will be permitted.\n* Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.\n* Any medical or social condition that in the opinion of the PI , may interfere with the study objectives, pose a risk to the participant, or prevent the participant from completing the study follow-up.\n* Any screening laboratory test result outside the normal range and with toxicity score ≥ 2, unless allowed by study team.\n* A positive serologic test for human immunodeficiency virus (HIV)-1 or HIV-2 (HIV 1/2 Ab), hepatitis B (HBsAg) or hepatitis C (HCV Ab).\n* History of malignancy, excluding non-melanoma skin and cervical carcinoma in situ.\n* Recent history (within the past year) or signs of alcohol or substance abuse.\n* History of major psychiatric disorder.\n* Female adult participants who are pregnant or breastfeeding.\n* Participant is an employee of, or direct descendant (child or grandchild) of any person employed by the Sponsor, PATH, the Contract Research Organization (CRO), the PI.'}, 'identificationModule': {'nctId': 'NCT06077656', 'briefTitle': 'Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inventprise Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults', 'orgStudyIdInfo': {'id': 'CVIA 105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation A administered by intramuscular injection on Day 1', 'interventionNames': ['Biological: IVT PCV-25 Formulation A']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1', 'interventionNames': ['Biological: IVT PCV-25 Formulation B']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Participants will receive a single 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1', 'interventionNames': ['Biological: IVT PCV-25 Formulation C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Participants will receive a single 0.5mL dose of PCV 20 administered by intramuscular injection on Day 1', 'interventionNames': ['Biological: PCV 20']}], 'interventions': [{'name': 'IVT PCV-25 Formulation A', 'type': 'BIOLOGICAL', 'description': '25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant', 'armGroupLabels': ['Group A']}, {'name': 'IVT PCV-25 Formulation B', 'type': 'BIOLOGICAL', 'description': '25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant', 'armGroupLabels': ['Group B']}, {'name': 'IVT PCV-25 Formulation C', 'type': 'BIOLOGICAL', 'description': '25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant', 'armGroupLabels': ['Group C']}, {'name': 'PCV 20', 'type': 'BIOLOGICAL', 'description': '20 valent pneumococcal conjugate vaccine', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Inventprise Clinical Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Inventprise Clinical Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B2N IL2', 'city': 'Truro', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Inventprise Clinical Site', 'geoPoint': {'lat': 45.36685, 'lon': -63.26538}}, {'zip': 'G1W 4R4', 'city': 'Saint-Louis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Inventprise Clinical Site', 'geoPoint': {'lat': 45.51737, 'lon': -73.57872}}], 'overallOfficials': [{'name': 'Sybil Tasker, MD, MPH, FIDSA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inventprise Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Plan to be defined at a later date', 'ipdSharing': 'YES', 'description': 'Plan to be defined at a later date', 'accessCriteria': 'Plan to be defined at a later date'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inventprise Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Canadian Center for Vaccinology', 'class': 'OTHER'}, {'name': 'Vaccine Evaluation Center, Canada', 'class': 'OTHER'}, {'name': 'PATH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-26', 'type': 'RELEASE'}, {'date': '2025-09-12', 'type': 'RESET'}, {'date': '2025-11-17', 'type': 'RELEASE'}, {'date': '2025-12-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Inventprise Inc.'}}}}