A phase II study of a C.difficile toxoid vaccine in patients with CDI.

• Research type

  Research Study

• Full 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-associated infection(CDI)

• IRAS ID

  6711

• Contact name

  Barry Cookson

• Sponsor organisation

  Sanofi Pasteur MSD S.N.C

• Eudract number

  2008-004907-69

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is designed to allowus to assess a novel vaccine to protect against C. difficile which is anorganism associated with morbidity and mortality in patients who becomeinfected often whilst staying in UK hospitals. The study will allowus to compare responses of people receiving this new vaccine with thosereceiving a placebo injection whilst being given the antibiotics that areroutinely used to treat C. difficile infections (CDI) in the UK. We willcompare how well those vaccinated are protected against disease, any reactionsto their vaccination (such as redness and swelling at the injection site) andany illnesses (such as headaches, malaise) and how their immune systems respondin making antibodies. We will enroll 700 healthy adults who are being treatedfor their first episode of CDI. Study duration (13 visits) for each subjectwill be approximately 210 days, with a planned Vaccination Period of 28 days, a63 day Principal Observation Period after the 3rd dose of vaccine, and aLong-term Follow-up Period. Screening Period: Prior to any study procedure,signed informed consent will be obtained. After this is obtained, screeningevaluations may be performed. All procedures for the Screening Period must becompleted and results obtained and analyzed within 5 days of vaccination on Day0. Vaccination Period (Day 0 to 28): Subjects will receive 3 doses of vaccineor placebo. Principal Observation Period (Day 29 to 91) and Long-Term Follow-upPeriod (Day 92-210): Recurrent events of CDI will be counted starting at thecompletion of antibiotic therapy and will continue through both of theseperiods. There may or may not be direct medical benefit to research subjectsfor taking part in this study, but it is possible that the vaccine will preventCDI recurrence. The information gained from this study may help to better treatpatients with CDI.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  08/H0206/62

• Date of REC Opinion

  21 Nov 2008

• REC opinion

  Further Information Favourable Opinion