Date: 2017-12-01
Type of
information: DSMB assessment
phase: 3
Announcement: discontinuation of development
Company: Sanofi Pasteur (France)
Product: Clostridium difficile vaccine (ACAM-CDIFF™)
Action
mechanism:
- vaccine. ACAM-CDIFF™ is a toxoid-based vaccine. It is designed to produce an immune response that targets the toxins A and B generated by C. difficile bacteria, which can cause inflammation of the gut and lead to diarrhea. It ultimately may help prevent a future infection from occurring. It has been developed by the UK vaccine company Acambis. Sanofi Pasteur has completed the acquisition of this company for £ 285 million in September 2008.
Disease: prevention of primary symptomatic Clostridium difficile infection
Therapeutic
area: Infectious diseases
Country: USA
Trial
details:
- This randomized, observer-blind, placebo-controlled, multi-center, multi-national trial will include up to 15,000 adults across 17 countries. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or who have had at least two hospital stays and have received systemic antibiotics in the past year are also eligible.
Latest
news:
- • On December 1, 2017, following a planned interim analysis, the Independent Data Monitoring Committee (IDMC) for the phase III Cdiffense clinical trial
program concluded that the probability that the study will meet its primary objective is low. Based on this, Sanofi has therefore decided to discontinue clinical development of
its experimental Clostridium difficile vaccine, to focus on six key vaccine projects currently in development.
Cdiffense is a trial designed to test the efficacy and safety of a candidate toxoid vaccine in a subpopulation at risk of Clostridium difficile infection. Sanofi Pasteur, the vaccines business of Sanofi responsible for the program, is informing all investigators, regulatory authorities and trial ethics committees. In addition, investigators are notifying study volunteers of the decision to stop the program. Data from all vaccinated volunteers in this trial will continue to be analyzed for more information and shared with the scientific community.
- • On August 5, 2013, Sanofi Pasteur, the vaccines division of Sanofi, has announced the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). The investigational vaccine is designed to help protect at-risk individuals from C. difficile, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide. The Cdiffense Phase III clinical program has just started recruiting volunteers at approximately 100 sites in the U.S. The FDA granted fast-track designation to Sanofi Pasteur’s investigational C. difficile vaccine candidate in 2010.
Is
general: Yes
