Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-30 @ 5:22 PM
Study NCT ID:
NCT01230957
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'dispFirstSubmitDate': '2013-12-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2010-10-28', 'dispFirstSubmitQcDate': '2013-12-03', 'studyFirstSubmitQcDate': '2010-10-28', 'dispFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.', 'timeFrame': '6 days after each vaccination and up to 6 months post-vaccination 3'}, {'measure': 'Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™.', 'timeFrame': 'Up to 6 months post-vaccination 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clostridium difficile infection', 'Diarrhea', 'Pseudomembranous colitis', 'Clostridium Difficile Toxoid Vaccine', 'ACAM-CDIFF™ vaccine'], 'conditions': ['Clostridium Difficile Infection', 'Diarrhea']}, 'referencesModule': {'references': [{'pmid': '27013431', 'type': 'RESULT', 'citation': 'de Bruyn G, Saleh J, Workman D, Pollak R, Elinoff V, Fraser NJ, Lefebvre G, Martens M, Mills RE, Nathan R, Trevino M, van Cleeff M, Foglia G, Ozol-Godfrey A, Patel DM, Pietrobon PJ, Gesser R; H-030-012 Clinical Investigator Study Team. Defining the optimal formulation and schedule of a candidate toxoid vaccine against Clostridium difficile infection: A randomized Phase 2 clinical trial. Vaccine. 2016 Apr 27;34(19):2170-8. doi: 10.1016/j.vaccine.2016.03.028. Epub 2016 Mar 21.'}, {'pmid': '31537446', 'type': 'DERIVED', 'citation': 'Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.\n\nPrimary Objectives:\n\n* To describe the safety profile of subjects in each of the study groups.\n* To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups.\n\nObservational Objective:\n\n* To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.', 'detailedDescription': 'Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™ vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different vaccination schedules using one of these formulations.\n\nParticipants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40 to 75 years on the day of inclusion\n* Informed consent form has been signed and dated\n* Able to attend all scheduled visits and to comply with all trial procedures\n* For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination\n* At risk for developing Clostridium difficile infection during the trial because of impending elective surgery or hospitalization within 60 days of enrollment, or current or impending residence in a long-term care facility or rehabilitation facility.\n\nExclusion Criteria:\n\n* Known pregnancy, or a positive urine pregnancy test\n* Currently breastfeeding a child\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine\n* Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines\n* Previous vaccination against Clostridium difficile with either the trial vaccine or another vaccine\n* Current or prior Clostridium difficile infection (CDI) episode\n* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C\n* Anticipated or current receipt of kidney dialysis treatment\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances\n* Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion\n* Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data\n* Subjects who have any history of intestinal diverticular bleeding\n* Subjects who have had surgery within the past three months for gastrointestinal (GI) malignancy.'}, 'identificationModule': {'nctId': 'NCT01230957', 'briefTitle': 'Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection', 'orgStudyIdInfo': {'id': 'H-030-012'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1114-3917', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (Low-dose with adjuvant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (Low-dose without adjuvant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Participants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Participants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (high-dose without adjuvant)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 5', 'description': 'Participants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.', 'interventionNames': ['Biological: Placebo: 0.9% normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': 'Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 7', 'description': 'Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively.', 'interventionNames': ['Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)']}], 'interventions': [{'name': 'Clostridium difficile toxoids A and B (Low-dose with adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 30', 'armGroupLabels': ['Group 1']}, {'name': 'Clostridium difficile toxoids A and B (Low-dose without adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 30', 'armGroupLabels': ['Group 2']}, {'name': 'Clostridium difficile toxoids A and B (high-dose with adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 30', 'armGroupLabels': ['Group 3']}, {'name': 'Clostridium difficile toxoids A and B (high-dose without adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 30', 'armGroupLabels': ['Group 4']}, {'name': 'Placebo: 0.9% normal saline', 'type': 'BIOLOGICAL', 'otherNames': ['0.9% normal saline'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 30', 'armGroupLabels': ['Group 5']}, {'name': 'Clostridium difficile toxoids A and B (high-dose with adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 7, and 180', 'armGroupLabels': ['Group 6']}, {'name': 'Clostridium difficile toxoids A and B (high-dose with adjuvant)', 'type': 'BIOLOGICAL', 'otherNames': ['ACAM-CDIFF™ vaccine'], 'description': '0.5 mL, Intramuscular on Days 0, 30, and 180', 'armGroupLabels': ['Group 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '06010', 'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 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'Cary', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '29464', 'city': 'Mt. 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