B5091007 Phase III Study of a Clostridium Difficile Vaccine
Research type
Research Study
Full title
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER
IRAS ID
220929
Contact name
Mark Wilcox
Contact email
Sponsor organisation
Pfizer Inc. 235 East 42nd Street, New York, NY 10017
Eudract number
2016-003866-14
Clinicaltrials.gov Identifier
Registration of Study with NIHR, 31054
Duration of Study in the UK
3 years, 2 months, 5 days
Research summary
Research Summary
The purpose of this study is to find out if an investigational vaccine prevents severe diarrhoea caused by a germ (bacterium) called Clostridium difficile (C diff) in adults 50 years of age and older. Vaccines help the body to make antibodies which help to fight against diseases.
C diff is a significant cause of infectious diarrhoea. Its severity can range from being mild to severe, and can lead to death. A person can become infected with C. difficile if they ingest the bacterium (through contact with a contaminated environment or person). It accounts for 20% to 30% of cases of antibiotic-associated diarrhoea. Most people who get C diff diarrhoea are older or have immune systems that are compromised and have hospital stays; see their doctor often; live in a nursing home; or take antibiotics.
Increased incidence and severity of the disease with associated complications, colectomy (surgical removal of any extent of the colon) rates, and mortality have been observed over the last 10 to 20 years. Key factors in this escalation include emergence of intensely harmful bacterium/virus or other microorganism, increased use of antibiotics, improved detection methods, and increased exposure to spores in healthcare facilities. In Europe, increased mortality, prolonged length of hospital stay, and increase cost of hospitalisation in association with C Diff Infection (CDI) have been reported. A systematic review published in 2012 reported 30-day mortality estimates in Europe ranging from 6.8% to 42%.
Across the World, around 16,000 people in around 25 countries who are 50 years of age or older who have an increased risk for CDI will take part in this study. Approximately 276 patients will be randomised in the UK across 16 sites.
This study is a placebo-controlled, randomised, observer-blinded study therefore the participants will receive the investigational C diff vaccine or a placebo. The participants will receive 3 injections over a period of 6 months. An investigational vaccine is one that is currently not approved for sale in this country. A placebo looks like the investigational vaccine, but does not have any active ingredients in it. For this study the placebo will be salt-water (also known as normal saline). To find out whether the vaccine prevents C diff diarrhoea, this study will closely monitor the participants for signs of infection for up to 3 years after they receive the last vaccine. Information will also be collected on any side effects the C diff vaccine might cause and the participants’ general health. Participants may need to visit the research site at least 5 times during the study and will also need to speak to the study team on the telephone.
During the first 6 months of the study the participants will be given vaccines and have blood taken at the research clinic. What happens at each of these visits is shown in the Patient Information Sheet and Protocol. Blood will also be taken to measure their immune response to the vaccine. On the days they receive the study vaccine/placebo, they will be asked to wait for at least 30 minutes for observation.
Summary of Results
Lay summary on Pfizer.com
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North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0092
Date of REC Opinion
24 May 2017
REC opinion
Further Information Favourable Opinion