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OpenTrials
Completed

NCT Number: NCT00772343

Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care.

Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

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Key information

Conditions

Diarrhea Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Infection Clostridium Infections Gram-Positive Bacterial Infections Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham Heartlands Hospital, Birmingham, United Kingdom

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About this study

This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their first event of CDI and are being treated with the antibiotic standard of care. This study will be conducted in the United States and United Kingdom. Adult subjects with limited chronic disease, who are currently receiving treatment for their first episode of CDI will be enrolled in this trial. Subjects will be required to be able to take oral antibiotics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
  • Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
  • Subjects who are medically stable.
  • Subjects who are willing and able to comply with the study procedures and visit schedules outlined.

Exclusion criteria

  • Subjects who are currently on treatment for a recurrence of CDI.
  • Subjects who are currently or have recently been treated with immunoglobulin therapy.
  • Pregnant or breast feeding females.
  • Concurrent, acutely life-threatening diseases.

Treatment and study plan

0.9% Normal Saline

Biological

0.5 mL, intramuscular on Days 0, 7, and 28

Other names: Normal Saline

Clostridium difficile toxoid vaccine

Biological

0.5 mL, intramuscular on Days 0, 7, and 28

Other names: ACAM-CDIFF™

Clostridium difficile toxoid vaccine with adjuvant

Biological

0.5 mL, intramuscular on Days 0, 7, and 28

Other names: ACAM-CDIFF™, ACAM-CDIFF™ Adjuvant

Primary outcomes

  1. Recurrence of Clostridium difficile infection.

    Time frame: Approximately 13 weeks after last injection

Secondary outcomes

  1. Safety and immunogenicity

    Time frame: Approximately 13 weeks after last injection.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Phase II Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of A Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection (CDI)

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 15, 2008
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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