C. Difficile Vaccination and Antimicrobial Resistance

Program Objective

The investigational vaccine is designed to help protect at-risk individuals from C. diff, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide. While not antibiotic resistant itself, C. difficile is strongly associated with antibiotic use and preventing CDI could have a significant impact on the development and spread of antimicrobial-resistant organisms.

Hospital-acquired infections are a major concern for public health in many industrialized countries and cause significant annual costs to the healthcare systems. Hospital-acquired infections are a major concern for public health in many industrialized countries and cause significant annual costs to the healthcare systems. Copyright Sanofi

What are the health needs and challenges?

Hospital-acquired infections are a major concern for public health in many industrialized countries and cause significant annual costs to the healthcare systems. Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of contracting CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. A main source of C. diff is infected patients who release spores into the environment that can then infect other people

Description of partnership activities and how they address needs and challenges

Sanofi Pasteur's candidate vaccine against Clostridium difficile takes a toxoid-based approach, which has been used extensively in Sanofi Pasteur's licensed vaccines against tetanus, diphtheria and pertussis (whooping cough). In August 2013, the company initiated a Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of its investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). The Cdiffense Phase III clinical program will include up to 15,000 adults at 200 sites across 17 countries.

In addition to developing a C. difficile vaccine that could help reduce the burden of CDI in the world today, Sanofi Pasteur is working with multiple external experts to quantify the potential benefits of preventing CDI as it relates to the development and transmission of AMR organisms.

Corresponding principle in Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance

We are investing in a range of innovative antibiotics, vaccines, alternative technologies, and diagnostics for resistant infections. We are advancing our pipelines, but more work and investment into multiple approaches is needed to overcome the significant scientific difficulties of antibiotic discovery.

Read full Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance (AMR)

Videos

Clostridium difficile infection

What is Clostridium difficile?

Partnership information

Therapeutic Focus Infectious Diseases

Disease(s) Drug-Resistant Infections (AMR)

Program Type(s) Prevention Programs - Vaccines, Research & Development - Development of Treatments

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean, Middle East & North Africa, North America, South Asia, Sub-Saharan Africa

Number of Countries 198

Country(ies) Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cape Verde, Central African Republic, Chad, Chile, China, Colombia, Comoros, Congo, Cook Islands, Costa Rica, Côte d'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Fiji, Finland, France, French Guiana, Gabon, Georgia, Germany, Ghana, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Hong-Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kiribati, Kosovo, Kuwait, Kyrgyzstan, Lao PDR, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mexico, Micronesia, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, Niue, North Korea, Norway, Oman, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Samoa, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Korea, South Sudan, Spain, Sri Lanka, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, The Gambia, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Start Date 2013

More information Sanofi Website

Anticipated completion date Ongoing