NCT01230957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

October 28, 2010

Last Update Submit

July 13, 2018

Conditions

Clostridium Difficile InfectionDiarrhea

Keywords

Clostridium difficile infectionDiarrheaPseudomembranous colitisClostridium Difficile Toxoid VaccineACAM-CDIFF™ vaccine

Outcome Measures

Primary Outcomes (2)

  • Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.

    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™.

    Up to 6 months post-vaccination 3

Study Arms (7)

Group 1

EXPERIMENTAL

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)

Group 2

EXPERIMENTAL

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)

Group 3

EXPERIMENTAL

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)

Group 4

EXPERIMENTAL

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)

Group 5

PLACEBO COMPARATOR

Participants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.

Biological: Placebo: 0.9% normal saline

Group 6

EXPERIMENTAL

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)

Group 7

EXPERIMENTAL

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

Clostridium difficile toxoids A and B (Low-dose with adjuvant)BIOLOGICAL

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

Also known as: ACAM-CDIFF™ vaccine
Group 1
Clostridium difficile toxoids A and B (Low-dose without adjuvant)BIOLOGICAL

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

Also known as: ACAM-CDIFF™ vaccine
Group 2
Clostridium difficile toxoids A and B (high-dose with adjuvant)BIOLOGICAL

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

Also known as: ACAM-CDIFF™ vaccine
Group 3
Clostridium difficile toxoids A and B (high-dose without adjuvant)BIOLOGICAL

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

Also known as: ACAM-CDIFF™ vaccine
Group 4
Placebo: 0.9% normal salineBIOLOGICAL

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

Also known as: 0.9% normal saline
Group 5

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Redding, California, 96001, United States

Location

Unknown Facility

Bristol, Connecticut, 06010, United States

Location

Unknown Facility

Stamford, Connecticut, 06905, United States

Location

Unknown Facility

Clearwater, Florida, 33756, United States

Location

Unknown Facility

Coral Gables, Florida, 33134, United States

Location

Unknown Facility

Port Orange, Florida, 32127, United States

Location

Unknown Facility

St. Petersburg, Florida, 33709, United States

Location

Unknown Facility

Tampa, Florida, 33614, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Idaho Falls, Idaho, 83404, United States

Location

Unknown Facility

Newton, Kansas, 67114, United States

Location

Unknown Facility

Brockton, Massachusetts, 02301, United States

Location

Unknown Facility

Troy, Michigan, 48098, United States

Location

Unknown Facility

Neptune City, New Jersey, 07753, United States

Location

Unknown Facility

Binghamton, New York, 13901, United States

Location

Unknown Facility

Endwell, New York, 13760, United States

Location

Unknown Facility

Cary, North Carolina, 27518, United States

Location

Unknown Facility

Hickory, North Carolina, 28602, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Centerville, Ohio, 45459, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15241, United States

Location

Unknown Facility

Uniontown, Pennsylvania, 15401, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

Unknown Facility

Salt Lake City, Utah, 84093, United States

Location

Unknown Facility

Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

Unknown Facility

Williamsburg, Virginia, 23185, United States

Location

Unknown Facility

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (2)

  • 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: 27013431RESULT

  • 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.

    PMID: 31537446DERIVED

MeSH Terms

Conditions

Clostridium InfectionsDiarrheaEnterocolitis, Pseudomembranous

Interventions

Adjuvants, PharmaceuticSaline Solution

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and UsesCrystalloid SolutionsIsotonic SolutionsSolutions

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2010

First Posted

October 29, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

US(30)