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Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults

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ClinicalTrials.gov Identifier: NCT01230957
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine. [ Time Frame: 6 days after each vaccination and up to 6 months post-vaccination 3 ]
  • Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™. [ Time Frame: Up to 6 months post-vaccination 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01230957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
Official Title  ICMJE 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
Brief Summary

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.

Primary Objectives:

  • To describe the safety profile of subjects in each of the study groups.
  • To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups.

Observational Objective:

  • To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
Detailed Description

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.

Participants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Clostridium Difficile Infection
  • Diarrhea
Intervention  ICMJE
  • Biological: Clostridium difficile toxoids A and B (Low-dose with adjuvant)
    0.5 mL, Intramuscular on Days 0, 7, and 30
    Other Name: ACAM-CDIFF™ vaccine
  • Biological: Clostridium difficile toxoids A and B (Low-dose without adjuvant)
    0.5 mL, Intramuscular on Days 0, 7, and 30
    Other Name: ACAM-CDIFF™ vaccine
  • Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
    0.5 mL, Intramuscular on Days 0, 7, and 30
    Other Name: ACAM-CDIFF™ vaccine
  • Biological: Clostridium difficile toxoids A and B (high-dose without adjuvant)
    0.5 mL, Intramuscular on Days 0, 7, and 30
    Other Name: ACAM-CDIFF™ vaccine
  • Biological: Placebo: 0.9% normal saline
    0.5 mL, Intramuscular on Days 0, 7, and 30
    Other Name: 0.9% normal saline
  • Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
    0.5 mL, Intramuscular on Days 0, 7, and 180
    Other Name: ACAM-CDIFF™ vaccine
  • Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
    0.5 mL, Intramuscular on Days 0, 30, and 180
    Other Name: ACAM-CDIFF™ vaccine
Study Arms  ICMJE
  • Experimental: Group 1
    Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (Low-dose with adjuvant)
  • Experimental: Group 2
    Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (Low-dose without adjuvant)
  • Experimental: Group 3
    Participants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
  • Experimental: Group 4
    Participants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (high-dose without adjuvant)
  • Placebo Comparator: Group 5
    Participants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.
    Intervention: Biological: Placebo: 0.9% normal saline
  • Experimental: Group 6
    Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
  • Experimental: Group 7
    Participants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively.
    Intervention: Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2010)
650
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 40 to 75 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • 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
  • 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.

Exclusion Criteria:

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
  • Previous vaccination against Clostridium difficile with either the trial vaccine or another vaccine
  • Current or prior Clostridium difficile infection (CDI) episode
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • 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)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C
  • Anticipated or current receipt of kidney dialysis treatment
  • 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
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as a study site employee who is involved in the protocol and may have direct access to trial-related data
  • Subjects who have any history of intestinal diverticular bleeding
  • Subjects who have had surgery within the past three months for gastrointestinal (GI) malignancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230957
Other Study ID Numbers  ICMJE H-030-012
UTN: U1111-1114-3917 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP