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CompletedNCT01230957Updated Jul 18, 2018

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

A Phase 2 interventional study of Clostridium difficile toxoids A and B (Low-dose with adjuvant) and Clostridium difficile toxoids A and B (Low-dose without adjuvant) in Clostridium Difficile Infection and Diarrhea, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 30 sites in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Clostridium Difficile Infection
  • Diarrhea

Keywords

  • Clostridium difficile infection
  • Diarrhea
  • Pseudomembranous colitis
  • Clostridium Difficile Toxoid Vaccine
  • ACAM-CDIFF™ vaccine
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 650 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
650 participants (actual)

Study arms

  • Experimental
    Group 1

    Participants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.

    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.

    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.

    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.

    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.

    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.

    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.

    Biological: Clostridium difficile toxoids A and B (high-dose with adjuvant)

Interventions

  • BiologicalClostridium difficile toxoids A and B (Low-dose with adjuvant)

    0.5 mL, Intramuscular on Days 0, 7, and 30

    Also known as: ACAM-CDIFF™ vaccine

  • BiologicalClostridium difficile toxoids A and B (Low-dose without adjuvant)

    0.5 mL, Intramuscular on Days 0, 7, and 30

    Also known as: ACAM-CDIFF™ vaccine

  • BiologicalClostridium difficile toxoids A and B (high-dose with adjuvant)

    0.5 mL, Intramuscular on Days 0, 7, and 30

    Also known as: ACAM-CDIFF™ vaccine

  • BiologicalClostridium difficile toxoids A and B (high-dose without adjuvant)

    0.5 mL, Intramuscular on Days 0, 7, and 30

    Also known as: ACAM-CDIFF™ vaccine

  • BiologicalPlacebo: 0.9% normal saline

    0.5 mL, Intramuscular on Days 0, 7, and 30

    Also known as: 0.9% normal saline

  • BiologicalClostridium difficile toxoids A and B (high-dose with adjuvant)

    0.5 mL, Intramuscular on Days 0, 7, and 180

    Also known as: ACAM-CDIFF™ vaccine

  • BiologicalClostridium difficile toxoids A and B (high-dose with adjuvant)

    0.5 mL, Intramuscular on Days 0, 30, and 180

    Also known as: ACAM-CDIFF™ vaccine

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

30 sites
  • Redding, California 96001, United States
  • Bristol, Connecticut 06010, United States
  • Stamford, Connecticut 06905, United States
  • Clearwater, Florida 33756, United States
  • Coral Gables, Florida 33134, United States
  • Port Orange, Florida 32127, United States
  • Saint Petersburg, Florida 33709, United States
  • Tampa, Florida 33614, United States
  • Atlanta, Georgia 30342, United States
  • Idaho Falls, Idaho 83404, United States
  • Newton, Kansas 67114, United States
  • Brockton, Massachusetts 02301, United States
  • Troy, Michigan 48098, United States
  • Neptune, New Jersey 07753, United States
  • Binghamton, New York 13901, United States
  • Endwell, New York 13760, United States
  • Cary, North Carolina 27518, United States
  • Hickory, North Carolina 28602, United States
  • Raleigh, North Carolina 27609, United States
  • Centerville, Ohio 45459, United States
  • Pittsburgh, Pennsylvania 15241, United States
  • Uniontown, Pennsylvania 15401, United States
  • Mount Pleasant, South Carolina 29464, United States
  • Bristol, Tennessee 37620, United States
  • Salt Lake City, Utah 84093, United States
  • Salt Lake City, Utah 84109, United States
  • Salt Lake City, Utah 84124, United States
  • Richmond, Virginia 23294, United States
  • Williamsburg, Virginia 23185, United States
  • Marshfield, Wisconsin 54449, United States
08

References and documents

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. PubMed 27013431 ↗
  • 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. PubMed 31537446 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01230957
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Oct 29, 2010
Start date
Oct 2010
Primary completion
Nov 2012
Completion
Mar 2013
Last update
Jul 18, 2018

Study contacts

Medical Director
study director · Sanofi Pasteur Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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