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

CompletedPhase 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Clostridium Difficile Infection, Diarrhea

Interventions: Clostridium difficile toxoids A and B (Low-dose with adjuvant), Clostridium difficile toxoids A and B (Low-dose without adjuvant), Clostridium difficile toxoids A and B (high-dose with adjuvant), Clostridium difficile toxoids A and B (high-dose without adjuvant), Placebo: 0.9% normal saline

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (30)

Redding, California, United States
Bristol, Connecticut, United States
Stamford, Connecticut, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Port Orange, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Newton, Kansas, United States
Brockton, Massachusetts, United States
Troy, Michigan, United States
Neptune City, New Jersey, United States
Binghamton, New York, United States
Endwell, New York, United States
Cary, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Centerville, Ohio, United States
Pittsburgh, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Bristol, Tennessee, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Williamsburg, Virginia, United States
Marshfield, Wisconsin, United States