Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-29 @ 2:37 AM
Study NCT ID:
NCT01031966
Status:
COMPLETED
Last Update Posted:
2012-03-29
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558220', 'term': 'focetria'}, {'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-28', 'studyFirstSubmitDate': '2009-12-11', 'studyFirstSubmitQcDate': '2009-12-14', 'lastUpdatePostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measures of immunogenicity, as determined by HI; MN and SRH', 'timeFrame': 'Geometric mean HI titer (GMT) on Day 0, Day 21, Day 42, Day 84 and Day 168 for the primary course'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ESRD'], 'conditions': ['END STAGE RENAL DISEASE']}, 'descriptionModule': {'briefSummary': 'The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.', 'detailedDescription': 'The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.\n\nUremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.\n\nDecreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.\n\nSince Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age \\> 18 .\n3. Chronic dialysis for ESRD .\n4. Life expectancy of at least 6 months.\n\nExclusion Criteria:\n\n1. They have any serious disease\n2. They are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.\n3. They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.\n4. Within the past 3 days, they have experienced fever (i.e., axillary temperature \\_ 38°C).\n5. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.'}, 'identificationModule': {'nctId': 'NCT01031966', 'briefTitle': "A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'sigma-tau i.f.r. S.p.A.'}, 'officialTitle': 'A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine', 'orgStudyIdInfo': {'id': 'ST1472-DM-09-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'H1N1sw monovalent vaccine', 'interventionNames': ['Biological: MF59 adjuvanted H1N1 influenza monovalent vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Thymosin alpha 1 3.2mg', 'interventionNames': ['Drug: Thymosin alpha 1']}, {'type': 'EXPERIMENTAL', 'label': 'Thymosin alpha 1 6.4 mg', 'interventionNames': ['Drug: Thymosin alpha 1']}], 'interventions': [{'name': 'MF59 adjuvanted H1N1 influenza monovalent vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Focetria™'], 'description': 'One/two single administration', 'armGroupLabels': ['H1N1sw monovalent vaccine']}, {'name': 'Thymosin alpha 1', 'type': 'DRUG', 'otherNames': ['Zadaxin'], 'description': '1.6 mg, 3.2 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)', 'armGroupLabels': ['Thymosin alpha 1 3.2mg']}, {'name': 'Thymosin alpha 1', 'type': 'DRUG', 'otherNames': ['Zadaxin'], 'description': '1.6 mg, 6.4 mg seven days before vaccination (study day -7) and at the same day of vaccination (study day 0)', 'armGroupLabels': ['Thymosin alpha 1 6.4 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Second Division of Nephrology and Dialysis - Padua Hospital', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Agostino Naso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Division of Nephrology and Dialysis - Padua Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'sigma-tau i.f.r. S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}