Tag Archives: Sanofi Pasteur

Utah doctor seeks patients to test vaccine to prevent C. diff. Infection (CDI)

The clinical trial being offered by Dr. Derek Muse, a medical director for Jean Brown Research  https://www.jeanbrownresearch.com/studies/c-diff-vaccine-study/

aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

C. diff has been called an “urgent threat to the public,” causing an estimated half-million infections and at least 29,000 deaths in the United States in 2011, according to the U.S. Centers for Disease Control and Prevention. Rates of infection increased 400 percent from 2000 to 2007, as more dangerous strains emerged and it has become more difficult to treat.

Clostridium difficile is a bacteria found in feces. People taking antibiotics increases the risks are more prone to picking it up, transmitting it from hand to mouth, as many of a person’s protective measures are depleted during antibiotic treatment.  C. diff. infections are also community acquired.

Dr. Muse said about half of the cases of C. diff occur in people younger than 65, but those in people age 65 and older remain in the high risk category and account for 95 percent of deaths related to the infection.

Symptoms include diarrhea, fever, nausea and other abdominal issues that can lead to a perforated colon and bacteria leaking into the bloodstream.

With this vaccine, we’re trying to reduce the chances they’d come down with this potentially virulent infection,” Muse said.

People most at risk for developing the infection include anyone who takes antibiotics, which includes patients who are hospitalized for any number of reasons, as well as those who are scheduled for various surgeries.

The clinical trial being offered by Dr. Muse, a medical director for Jean Brown Research, aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

“Our hope is that they’d be protected for their lifetime, but we just don’t know that yet,” Muse said. “It’s something that would be evaluated by the results of the trial.”

The trial, sponsored by global pharmaceutical company SanofiPasteur, needs 15,000 enrollees across 20 countries throughout the world to reach statistical significance. The company has successfully developed vaccines for tetanus, typhoid, pertussis, rabies and more. It also manufactures the influenza vaccine most commonly used in the market today.

***  To be eligible for the clinical trial to evaluate effectiveness against C. diff, patients *must be age 50 or older
*hospitalized twice in the past year for 24 hours or more
*and/or planning to have an upcoming surgical procedure.

Dr. Muse said the study doesn’t guarantee participants will receive the active vaccination, as placebos are used to confirm the research.

“We’re trying to bring very helpful medications to the market and that requires a lot of volunteers,” he said. “In the end, we ask patients to sacrifice a little bit of their time to participate in these studies and some medications end up saving millions of lives all over the world.”

A number of vaccines come out each year, including one for meningitis that became available earlier this year. An update of the human papillomavirus vaccination, as well as one to help the elderly avoid pneumonia are also newly available.

“These things cause so much suffering,” Muse said. “Doctors want these vaccines yesterday.”

Muse blames over-prescription of antibiotics for the growing number of cases of C. diff. Antibiotics, he said, can destroy the normal bacteria in the intestine, which can result in overgrowth of toxic spores that can injure the lining of the colon and cause diarrhea, abdominal pain and bloody stool.

The key, he said, is preventing C. diff altogether.

Antibiotic Use:  “Talk with your doctor whether you really need an antibiotic or not,” Muse said. “Many upper respiratory infections don’t need antibiotic treatment. Even mild sinus infections don’t have to be treated.”

*Utilize natural remedies when treating symptoms caused by viruses and discuss over the counter medications and alternatives available with the healthcare provider.

Antibiotics, unless necessary, should be deferred or delayed until necessary

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

 

To read the article in its entirety click on the following link:

http://www.deseretnews.com/article/865636216/Utah-doctor-seeking-patients-to-test-vaccine-to-prevent-potentially-debilitating-infection.html

C Diff Foundation’s “Raising C.diff Awareness” Continuing Education Workshop Launched in Community Colleges

cdiffhandwashingbreakpostercdiffInfControl Healthcare Professionals, employed in all areas of healthcare, attended the first “Raising C. diff. Awareness” Continuing Education class being offered in allied health at the Community Colleges.

Attendees learned about C. difficile prevention, treatments, and environmental safety.

ShelbyTeachingThe class learned how to prevent contamination with the opportunity to practice safe infection control techniques, discuss the physical, psychological, social, and financial impact this infection causes to a patient, families, and healthcare industry and how to prevent infections in their everyday practices.

Congratulations to all the attendees of “Raising C. diff. Awareness” Continuing Education Workshop – Spring Class 2015!  Each attendee learned something new today and each has a voice – Now is the time to take the knowledge and continue raising C. diff. awareness in every area of practice.  Each student joins us in the shared goal~  to witness a decrease in newly diagnosed   C. diff. infections worldwide.

Thank you to all who attended this workshop and it was a pleasure to provide you with valid information for C. diff. prevention, treatments, and environmental safety.

“None of us can do this alone…..all of us can do this together!”

 

CdiffRCDA-2May2015

 

LindaAngelo CdiffRCDA-3May2015 CdiffRCDAgroupMay2015 CdiffRCDA-5May2015 CdiffRCDA-7May2015

Taught by:
Nancy Caralla, Founding Executive Director C Diff Foundation,
Shelby Lassiter, RN, BSN, CPHQ, CIC, Consulting Infection Preventionist for C Diff Foundation
Karen Factor, RD, MBA, Chairperson Nutrition and Wellness C Diff Foundation
Angelo Ortiz, Treasurer, C Diff Foundation
Linda Davis, RN, BSN, Community Nurse for C Diff Foundation

Continuing Education through Durham Community Colleges

Sanofi Pasteur Discusses Developing a Preventative C.diff. Infection Vaccine March 17, 2015 with C Diff Foundation’s ‘C diff Spores and More’ #CdiffRadio

cdiffRadioLogoMarch2015C. diff. Spores and More”

We invite you to join us in listening to this exciting episode on March 17th, 2015 and every Tuesday at the following times:

11a – 12p PT, 12p – 1pm MT, 1 pm – 2 pm CT,                              2 pm – 3 pm ET

 

Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is currently conducting a Phase III clinical trial called Cdiffense in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic Clostridium difficile infection (CDI). The Cdiffense Phase III clinical program hopes to recruit up to 15,000 adults over 200 sites across the 20+ countries.

SANOFI Pasteur - RVB - Colors[1]Sanofi Pasteur’s Dr. Christian Felter, MD is Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine.

Dr. Patricia J. Freda Pietrobon, PhD, Associate Vice President, R&D, Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines.

Dr. Guy de Bruyn, Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Listen in on March 17th  as these three  Sanofi Pasteur professionals discuss the background of acquiring a C.difficile infection,  Sanofi Pasteur’s Phase III clinical trial called Cdiffense,  and data from the preventative vaccine in Phase II

Click on the link below to access the C. diff. Spores and More Show Page:

www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

 

C. diff. and Healthcare-Associated Infections Discussed Live on C. diff. Radio

CdiffRadioPost

#CdiffRadio

C Diff Foundation, Sponsor, with Founder            Nancy C. Caralla, Executive Director and               Dr. Chandrabali Ghose, Chairperson of the Research and Development Community will be broadcasting live on Tuesdays delivering the most up-to-date information pertaining to a leading super-bug/ Healthcare Associated Infection (HAI),  C. difficile, with additional HAI’s, and a variety of related healthcare topics.

Topic experts will be joining your hosts to discuss prevention, treatments, clinical trials, and environmental safety products on a global level.

Tune in Tuesdays beginning March 3rd at 11 AM Pacific Time (2 PM Eastern Time, 7 PM UK) on the VoiceAmerica network  http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

Meridien Research in Tampa Bay – Florida, Seeking Volunteers For C. diff. Vaccine Clinical Research Trial

Sanofi Pasteur MeridienH-030-014_CDIF10010A-1_ STP

Are You at Risk for C. Diff?

C. diff is a bacterium that can cause mild diarrhea to life-threatening bowel disease. The risk of  acquiring C. diff. increases with age, the use of antibiotics and time spent in hospitals or in nursing homes.

Volunteers are needed for research study being conducted to evaluate the effects of an investigational vaccine for C.diff infections. You may qualify if you are 50 years old or older, are planning a hospitalization, and/or have had at least 2 recent hospital stays within the past year.

Qualified participants may receive at no cost study-related:
     ● Evaluations, physical exams, routine lab work
     ● Investigational medication or placebo

Compensation for time and travel may be available. No medical insurance is necessary.

Call 1-727-347-8839 (USA) for more information.

  About Meridien

Meridien Research  provides patients and families in the Tampa Bay area an opportunity to take part in clinical research trials for a wide variety of medical conditions. These research trials are usually offered at University or large research institutions, but with offices in Tampa, St. Petersburg, Brooksville, Bradenton and Lakeland, area residents can have access to the latest in medical research without leaving home.

Stephanie Jones, Director of Marketing

 

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Insearch Group

9455 Koger Blvd.

Suite 111

St. Petersburg, FL 33702

727.544.4842

sjones@insearchgroup.net

www.newstudyinfo.com

 

 

 

C. difficile; Sanofi Pasteur Announces Favorable Phase II Study Results

Sanofi Pasteur Announces Favorable Phase II Study Results for Investigational Clostridium difficile Vaccine at the American Society for Microbiology Meeting

 

Results indicate vaccine generates an immune response against key toxins
in volunteers and establish dosing for Phase III 

Boston, United States of America – May 19, 2014 – Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), presented Phase II (H-030-012) trial results for an investigational vaccine for the prevention of Clostridium difficile (C. diff) infection (CDI) at the 114th General Meeting of the American Society for Microbiology (ASM). The Phase II trial met its primary objectives, reactions were generally mild and of short duration, and the candidate vaccine generated an immune response against C. diff toxins A and B. These toxins are largely responsible for CDI, which can cause potentially life-threatening gut inflammation and diarrhea.

 

Based on the Phase II results, a high-dose plus adjuvant vaccine formulation administered on days 0, 7 and 30 was selected for further evaluation in the global efficacy program Cdiffense. This ongoing Phase III trial began in August 2013 with plans to include up to 200 sites in 17 countries.

 

C. diff infection threatens the many people who frequently use antibiotics, as well as older hospitalized patients and residents in long-term healthcare facilities,” said Jamshid Saleh, M.D., who participated in Phase II and is currently the principal investigator in the Phase III trial at Northern California Clinical Research Center in Redding, California. “It would be great if we could offer patients a way to help prevent this contagious and debilitating disease versus just treating it after it happens.

 

The Phase II vaccine study was a randomized, multi-center trial split into two stages. The first, conducted with 455 volunteers, was placebo-controlled, double-blind and designed for dose and formulation selection. The second, which included 206 additional volunteers, was designed to compare the dose and formulation chosen in the first stage against two alternate dosing schedules. Volunteers in the study were adults aged 40-75 years who were at risk of CDI due to impending hospitalization or residence in a long-term healthcare facility.

 

In this trial, we saw a significant increase in antibody production against C. diff toxins, across all dosing schedules and volunteer ages,” said Guy De Bruyn, MBBCh MPH, Director, Clinical Development, Sanofi Pasteur, who presented the data at ASM. “These results provide a strong foundation for our efforts to develop and offer a vaccine to prevent first occurrence CDI.

 

In Stage 1 of this trial, volunteers were randomized into one of five study groups: high-dose or low-dose vaccine either with or without adjuvant, or placebo. Each formulation was administered on days 0, 7 and 30. Immune responses were measured using both Enzyme Linked Immunosorbent Assay (ELISA), which assesses anti-toxin A and B immunoglobulin G (IgG) concentrations, and Toxin Neutralization Activity (TNA), which measures anti-toxin A and B neutralizing activity. Composite ELISA ranking analysis determined that the high-dose plus adjuvant vaccine formulation (Group 3) generated the greatest immune response over a 60-day period. ELISA results also showed four-fold increases in the development of detectable antibodies for both toxins A and B.

 

The high-dose plus adjuvant vaccine formulation was then selected for further study in Stage 2 of the trial, which compared its use across three schedules: days 0, 7 and 30 (Group 3, N=101); days 0, 7 and 180 (Group 6, N=103); and days 0, 30 and 180 (Group 7, N=103). Analysis was conducted on days 0, 7, 14, 30, 60, 180 and 210.

 

Increased immune responses were observed in all vaccine groups and with each dose, according to ELISA and TNA. Overall, Group 3 demonstrated the most favorable immune profile over the 30-, 60- and 180-day periods, particularly in volunteers aged 65-75 years.

 

The safety profile of all vaccine doses was deemed acceptable throughout the Phase II study. Reactions were monitored until day 210 and were generally Grade 1 (classified as mild), of short duration, did not lead to study discontinuations, and were not considered clinically significant.

 

Sanofi Pasteur’s investigational vaccine stimulates a person’s immune system to fight C. diff toxins upon exposure and, ultimately, may help prevent a future CDI from occurring,” said Dr. Saleh. “Like other toxoid vaccinessuch as tetanus, diphtheria and whooping coughthis investigational vaccine targets the symptom-causing toxins generated by C. diff bacteria and could be an important public health measure to help protect individuals from CDI.

 

Analysis of available data indicates that CDI may have resulted in up to $4.8 billion in excess costs in acute-care facilities in the United States (U.S.) during 2008.4 In 2009, U.S. hospital stays in which CDI was a principal diagnosis averaged 6.9 days and $10,100.When CDI was a complicating factor to already complex principal diagnoses (e.g., septicemia, pneumonia, congestive heart failure, renal failure), hospital stays more than doubled and costs more than tripled (16 days and $31,500, respectively).5

 

About Sanofi

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

 

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: http://www.sanofipasteur.com or www.sanofipasteur.us

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Cdiffense – Sanofi Pasteur’s Clinical Vaccine Trial for C. diff. Prevention Now in Phase III

Sanofi Pasteur’s Clinical Vaccine Trial for Prevention of C.diff Now in Phase III Stage

Sanofi Pasteur, one of the world’s largest vaccine manufacturers, is developing a vaccine for prevention of Clostridium difficile.

Because of the unmet medical need regarding this disease, in 2010, The U.S. Food and Drug Administration (FDA) granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The vaccine is now in the Phase III stages of its Clinical Vaccine Trial and is looking for volunteers in several countries to participate in this preventative vaccine trial.

For more information regarding the Cdiffense Cdiff vaccine trial and trial centers, please visit http://www.cdiffense.org