Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 8:57 AM
Study NCT ID:
NCT01798095
Status:
UNKNOWN
Last Update Posted:
2013-02-25
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Equivalence Study of Specificity of PPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales 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': 'D000085343', 'term': 'Latent Infection'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014373', 'term': 'Tuberculin'}, {'id': 'D012015', 'term': 'Reference Standards'}], 'ancestors': [{'id': 'D000942', 'term': 'Antigens, Bacterial'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2013-01-31', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of similarity in responses', 'timeFrame': '72 hours', 'description': 'To determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.Skin test responses will be used to determine product similarity in responses.'}], 'secondaryOutcomes': [{'measure': 'Determine equivalent specificity', 'timeFrame': '72 hours', 'description': 'To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb; 2) To assess the tolerability of the investigational products in terms of the localand systemic reactogenicity events. Skin responses to new PPD and reference standard will be monitored to determine equivalent specificity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TB, Aplisol'], 'conditions': ['Tuberculosis Infection']}, 'descriptionModule': {'briefSummary': 'Determine if investigational products and reference standard produce similar responses.', 'detailedDescription': 'Primary:\n\nTo determine if the 2 investigational products (Aplisol formulated from the new Tuberculin PPD drug substance and the reference standard PPD-S2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with M. tuberculosis (Mtb) or other mycobacteria.\n\nSecondary:\n\n1. To determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with Mtb;\n2. To assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or nonpregnant females, age 18 to 70 years\n\n * Negligible risk of manifesting a positive PPD test as evidenced by:\n\n * Prior history of negative PPD test or interferon gamma release assay (IGRA) within 14 months before Screening\n * No history of Bacillus Calmette- Guérin vaccination; or if vaccination status is uncertain, was born in the US and did not live outside the US as a child\n * No history of Mtb or Mtb therapy (including isoniazid, rifampin, ethambutol, pyrazinamide, or streptomycin)\n * No history of infection with atypical mycobacteria, including suspicious chest roentgenogram\n * No history of high risk medical conditions (eg, HIV infection or other immunosuppressive conditions, severe chronic renal disease \\[as evidenced by a creatinine clearance \\< 30 ml/min\\], poorly controlled diabetes mellitus, silicosis, intravenous drug use, or alcohol abuse)\n * No known close contact to a confirmed Mtb case (family or social setting)\n * No history of living or travelling in India, China, Sub-Saharan Africa, or Southeast Asia in the past 6 months\n * No exposure (other than casual) to high-risk environments for Mtb exposure (eg, prisons, homeless shelters); healthcare workers are allowed\n\nExclusion Criteria:\n\n* Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating\n\n * History of anaphylactic type reaction or other severe reaction to PPD in the past, including a history of blistering or sloughing\n * Presence of conditions that may suppress TST reactivity, including:\n\nProtocol No. JHP-Aplisol-03 Confidential 04 May 2012 Page 8 of 38\n\n* Acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (HIV1, HIV2). Mild viral syndromes are allowed.\n* Acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis\n* Acute systemic fungal infection\n* Live virus vaccinations within the past 6 weeks, including measles, mumps, polio, varicella, or FluMist®\n* Metabolic derangements (eg, poorly controlled diabetes, Cushing syndrome, chronic renal failure \\[as evidenced by a creatinine clearance \\< 30 ml/min\\])'}, 'identificationModule': {'nctId': 'NCT01798095', 'acronym': '03', 'briefTitle': 'Equivalence Study of Specificity of PPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'JHP Pharmaceuticals LLC'}, 'officialTitle': 'A Randomized, Double-blind, Equivalence Study of the Specificity of Tuberculin Purified Protein Derivative (PPD) (Aplisol®) in Comparison With a Reference Standard', 'orgStudyIdInfo': {'id': 'JHP-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aplisol', 'description': 'To confirm the response of PPD materials', 'interventionNames': ['Biological: Aplisol@ PPD material', 'Biological: Reference Standard']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPD Standard', 'description': 'Determine equivalent specificity for new material compared to standard material.', 'interventionNames': ['Biological: Aplisol@ PPD material', 'Biological: Reference Standard']}], 'interventions': [{'name': 'Aplisol@ PPD material', 'type': 'BIOLOGICAL', 'otherNames': ['Aplisol@'], 'description': 'Determine equivalency of materials', 'armGroupLabels': ['Aplisol', 'PPD Standard']}, {'name': 'Reference Standard', 'type': 'BIOLOGICAL', 'otherNames': ['US Reference Standard'], 'description': 'Reference standard material for comparison to newly produced materials.', 'armGroupLabels': ['Aplisol', 'PPD Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Joe Santor, Pharm. D.', 'role': 'CONTACT', 'email': 'clin.res@uthct.edu', 'phone': '903-877-7632'}, {'name': 'David Griffith, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas Health Science Center at Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'centralContacts': [{'name': 'Arlene Lund, B.Sc.', 'role': 'CONTACT', 'phone': '919-985-3220'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JHP Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}