Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
Study NCT ID:
NCT03998592
Status:
WITHDRAWN
Last Update Posted:
2021-02-04
First Post:
2019-06-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012213', 'term': 'Rheumatic Fever'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, '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'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Agreement between interested partied ended', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Solicited and unsolicited adverse reactions', 'timeFrame': 'Six months after last dose', 'description': 'Frequency of solicited and unsolicited adverse reactions'}, {'measure': 'Immune response to vaccine', 'timeFrame': 'Six months after last dose', 'description': 'Rate of seroconversion for vaccine epitopes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccine', 'peptide', 'Streptococcus pyogenes'], 'conditions': ['Rheumatic Fever']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled phase I clinical trial with dose-escalation of a synthetic vaccine against Streptococcus pyogenes. The active component of this vaccine candidate is a synthetic polypeptide named StreptInCor designed to elicit humoral and cell-mediated immune responses. The vaccine will be formulated with Aluminium hydroxide in three different doses of StreptInCor (50 µg, 100µg, 200 µg). The proposed vaccination schedule is three doses (0, 1, 6 months). The doses will be escalated for the next group after safety review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, both sex, aging 18 to 45 years;\n* Availability for all procedures during the study period;\n* Provide free informed consent to join the study\n\nExclusion Criteria:\n\n* Diagnosis of concomitant infections or diseases that might affect immunity, including active HIV infection, hepatitis B, hepatitis C, diabetes mellitus, neoplasias, and autoimmune diseases;\n* Previous or current diagnosis or family antecedent of rheumatic fever, chorea, obsessive-compulsive disorder or glomerulonephritis;\n* Previous or current diagnosis of cardiac disease;\n* Severe asma or Chronic obstructive pulmonary disease (COPD);\n* Abnormal neurological clinical assessment, particularly chorea;\n* Use of treatments that might affect the immunity in the last four weeks, including immunomodulators, corticosteroids (only systemic use equal or longer than two weeks), or antineoplastic agents;\n* Use of treatments that might affect heart valves in the latest four weeks, including fenfluramine e dexfenfluramine;\n* Kidney failure determined by creatinine clearance lower than 45 ml/min/1,73m²;\n* History of intolerance or allergy to any component of investigational products, including antigen or adjuvant;\n* Presence of abnormalities in heart valves or heart anatomy defined by echocardiogram;\n* Electrocardiogram disturbances;\n* Presence of cross-reactive antibodies against human tissues (heart, kidney, cartilage, brain) in screening tests;\n* Evidence or suspicion of recent infection due to S. pyogenes assessed by clinical symptoms and negative rapid test for Streptococcus;\n* Pregnancy, breastfeeding mother or intention to became pregnant during the study period;\n* Any other condition that might affect the study process according to the investigators.'}, 'identificationModule': {'nctId': 'NCT03998592', 'briefTitle': 'Clinical Trial to Assess Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Butantan Institute'}, 'officialTitle': 'Phase I Clinical Trial for Assessment of Safety and Immunogenicity of a Synthetic Vaccine Against Streptococcus Pyogenes in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EGA-01-IB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose vaccine', 'interventionNames': ['Biological: Streptococcus pyogenes vaccine (50 µg)']}, {'type': 'EXPERIMENTAL', 'label': 'Mid-dose vaccine', 'interventionNames': ['Biological: Streptococcus pyogenes vaccine (100 µg)']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose vaccine', 'interventionNames': ['Biological: Streptococcus pyogenes vaccine (200 µg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Streptococcus pyogenes vaccine (50 µg)', 'type': 'BIOLOGICAL', 'description': 'Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant', 'armGroupLabels': ['Low-dose vaccine']}, {'name': 'Streptococcus pyogenes vaccine (100 µg)', 'type': 'BIOLOGICAL', 'description': 'Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant', 'armGroupLabels': ['Mid-dose vaccine']}, {'name': 'Streptococcus pyogenes vaccine (200 µg)', 'type': 'BIOLOGICAL', 'description': 'Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant', 'armGroupLabels': ['High-dose vaccine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo without active component', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Luiza Guilherme, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'InCor Heart Institute'}, {'name': 'Roney O Sampaio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butantan Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'InCor - Instituto do Coração - HCFMUSP.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}