Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 12:03 PM
Study NCT ID:
NCT05193734
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2021-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D000079263', 'term': 'Vaccine-Preventable Diseases'}], 'ancestors': [{'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C011820', 'term': 'FHD'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-23', 'size': 1574325, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-23T12:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-11', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine', 'timeFrame': '1 year', 'description': 'The primary objective is to assess the immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine (Pertagen®) including genetically-detoxified pertussis toxin (rPT) administered at 6 months interval and delivered by the intramuscular route to adults aged 18-30 years previously primed and boosted with chemically-detoxified PT.\n\nThe main immunogenicity endpoints will be the geometric mean concentration (GMC) of anti-PT neutralizing antibodies assessed 4 weeks (early immunity) and 6 months (sustained immunity) following one or two injections of Pertagen® given at 6 months interval'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events OBJECTIVE', 'timeFrame': 'Solicited local and systemic reactions will be followed up for 7 days and AEs for 28 days after vaccination', 'description': 'Safety endpoints evaluated by solicited local and systemic reactions and unsolicited adverse events (AEs)'}, {'measure': 'Humoral immune response', 'timeFrame': 'At 28 days after vaccination', 'description': 'GMCs and seroresponse rates of PT, FHA, tetanus and diphtheria-toxoid specific IgG antibodies measured by ELISA and specific elicited by two doses of Pertagen® as compared to a single dose.'}, {'measure': 'Cellular immune response', 'timeFrame': 'At 28 days after vaccination', 'description': 'Concentration of specific memory B cells for PT, tetanus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pertussis', 'Vaccine-Preventable Diseases']}, 'descriptionModule': {'briefSummary': 'A significant increase of pertussis incidence is reported in a growing number of countries. This resurgence is considered as resulting from the limited durability of aP-vaccine-induced immunity and is associated with increased mortality in young infants and morbidity at all age groups. As the pertussis immunity acquired through immunization or infection is short-lived, its maintenance or reactivation requires repeat boosting at regular time points. Thus, novel strategies capable of reactivating pertussis immunity are needed.\n\nThe efficacy of current acellular pertussis vaccines (which contain chemically-detoxified pertussis toxoid (PT)) rapidly wanes, in part because priming and repeat immunization with acellular vaccines induce antibodies specific for the chemically-detoxified PT but unable to efficiently recognize the native PT expressed by B. pertussis.\n\nClinical studies have shown the superior immunogenicity profile of acellular pertussis vaccines including genetically-detoxified PT (rPT) in adults and adolescents previously primed with aP. In particular, the investigators showed in a past Geneva study in teenagers previously primed with aP that rPT/FHA induced a stronger recall response than the current aP-vaccine at one month post-vaccination. However, the difference was less clear one year after vaccination, suggesting that 2 doses may be needed for more sustained immunity.\n\nIn the present study, the investigators would like to assess whether giving two doses of rPT/FHA at 6 months interval induces stronger immune responses than a single dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has provided written informed consent;\n* Male or female, ages 18 to 30 years (inclusive) at the time of enrollment;\n* With documented history of acellular pertussis immunization (5 doses);\n* Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;\n* Non-pregnant, non-lactating females :\n* Able to attend all scheduled visits during one year and to understand and comply with the study procedures;\n\nExclusion Criteria:\n\n* Prior dTpa immunization within the last 5 years or prior dT immunization within the last 2 years, or any other investigational vaccine likely to impact on interpretation of the trial data\n* Suspected or confirmed pertussis infection within the last 10 years or documented pertussis infection in a household member within the last 10 years;\n* History of severe local or systemic reactions to any vaccination;\n* Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis-containing vaccines (including excipients);\n* Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial;\n* Receipt of licensed vaccines within 30 days of planned study immunization or ongoing participation in another clinical interventional trial likely to interfere with study results;\n* Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history and physical exam;\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the previous 5 years, and/or diabetes;\n* Has a known history of vaccine-induced Guillain-Barré Syndrome;\n* Has an active malignancy or recent (\\<10 years) history of metastatic or hematologic malignancy;\n* Suspected or known alcohol and/or illicit drug abuse within the past 5 years;\n* Pregnant or lactating female, or female intending to becoming pregnant during the study period;\n* Administration of immunoglobulins within the 120 days preceding study entry or planned administration during the study period;\n* History of blood donation (at least 450 ml) within 30 days of enrollment or plans to donate within the 30 days following and preceding each blood draw;\n* Receipt of chronic (\\>14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry:\n* Any other significant finding that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study."}, 'identificationModule': {'nctId': 'NCT05193734', 'acronym': 'Pertagen2x', 'briefTitle': 'Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'A Phase II/III Randomized, Double-blind Controlled Study to Compare the Safety and Immunogenicity of 1 or 2 Doses of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines', 'orgStudyIdInfo': {'id': 'PERTAGEN2x'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Pertagen', 'interventionNames': ['Drug: Pertagen®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Control', 'interventionNames': ['Drug: Revaxis®']}], 'interventions': [{'name': 'Pertagen®', 'type': 'DRUG', 'otherNames': ['Genetically detoxified pertussis toxin (rPT) and filamentous hemagglutinin (FHA), alum adsorbed'], 'description': 'Schedule:\n\nGroup Pertagen will receive two doses of Pertagen®. (one vaccination on Day 0 and 6 months later for each volunteer.)\n\nMode of Administration:\n\nIntramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle.', 'armGroupLabels': ['Group Pertagen']}, {'name': 'Revaxis®', 'type': 'DRUG', 'description': 'Schedule:\n\nGroup Control will receive one dose of Revaxis® on Day 0 followed by 1 dose of Pertagen® 6 months later for each volunteer.\n\nMode of Administration:\n\nIntramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle.', 'armGroupLabels': ['Group Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Gualtieri Renato, MD', 'role': 'CONTACT', 'email': 'renato.gualtieri@hcuge.ch', 'phone': '+41 (0)79 55 35 509'}], 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'GUALTIERI Renato, MD', 'role': 'CONTACT', 'email': 'renato.gualtieri@hcuge.ch', 'phone': '+41 (0)79 55 35 509'}], 'overallOfficials': [{'name': 'BLANCHARD ROHNER Geraldine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Blanchard-Rohner Geraldine', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}