C. difficile Vaccine for C. diff Infection
(BEETHOVEN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a vaccine designed to reduce infections caused by Clostridioides difficile, a bacterium that can lead to severe diarrhea and other intestinal issues in older adults. Participants will receive either the new C. difficile vaccine or a placebo (a shot with no active ingredients) to evaluate the vaccine's effectiveness and safety. The study targets individuals 65 and older who have recently interacted with healthcare systems or taken antibiotics. Participants will have regular clinic and phone check-ins, and the trial may last up to three and a half years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that the C. difficile vaccine is likely to be safe for humans?
Studies have shown that the C. difficile vaccine is generally safe. In one study, participants received the vaccine in three doses and tolerated it well, experiencing no major issues or unexpected side effects. Another study confirmed the vaccine's safety, noting no serious problems. Although the vaccine did not fully achieve its main goal in some research, it still helped shorten the duration of symptoms for those infected. Overall, these findings suggest that the vaccine is safe for humans.12345
Why do researchers think this study treatment might be promising?
Most treatments for C. difficile infections involve antibiotics like vancomycin or metronidazole that target the bacteria causing the infection. However, the C. difficile vaccine is different because it aims to prevent the infection from occurring in the first place. This vaccine introduces a novel formulation that stimulates the immune system to recognize and fight off C. difficile bacteria before they can cause harm. Researchers are excited about this approach because it could significantly reduce infection rates and reliance on antibiotics, which often lead to resistance and other complications.
What evidence suggests that the C. difficile vaccine is effective for C. diff infection?
Research has shown that the C. difficile vaccine, which participants in this trial may receive, might help lower infection rates. In one study, patients who received three doses of the vaccine recovered from symptoms 75% faster. Another study using animals found that the vaccine could protect against severe infection and even death. These results suggest that the vaccine might reduce the risk of C. difficile infections in people. While more research is needed, these early findings are promising.56789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This study is for people aged 65 or older to learn about the effectiveness of a C. difficile vaccine in preventing infections. Participants must be willing to receive injections and follow up with clinic visits and phone calls.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive either the C. difficile vaccine or placebo as a shot into the upper arm muscle
Surveillance
Participants are monitored for the incidence of C. difficile infections and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- C.difficile vaccine
Trial Overview
The trial is testing a C. difficile vaccine against a saline placebo, given as shots in the upper arm muscle, to see if it reduces infection rates. The duration depends on how quickly infection-related diarrhea events occur.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Novel vaccine formulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Against Clostridioides difficile Infection: An Update on Vaccine ...
In murine models, this vaccine confers protection against lethal CDI in both primary infection and recurrent infection scenarios, exhibiting ...
Preferences for a Clostridioides difficile vaccine among ...
This study assessed US adults' willingness to receive a C.diff vaccine and examined how vaccine attributes influence their choices.
CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A ...
Although the primary end point was not met, secondary and post hoc analysis results indicated 3 PF-06425090 doses reduced median time to CDI resolution by 75%.
mRNA Vaccine Shows Potential for C difficile Infections
The research represents a promising proof of principle that mRNA vaccines could be effective in preventing C difficile disease. Looking forward, ...
A “butt vaccine” against C. diff-associated diarrhea
We have been able to show that the “butt vaccine” prevents death and toxin-induced tissue damage while clearing C. diff spores. Our results ...
Safety and Immunogenicity of an Adjuvanted Clostridioides ...
This study investigated the safety, reactogenicity, and immunogenicity in healthy subjects of a Clostridioides difficile vaccine candidate with/without ...
Clostridioides difficile Infection (CDI) Surveillance | HAIs
The Clostridioides difficile infection (CDI) Surveillance Program collects data for describing incidence and trends of these infections.
Clostridium difficile - Pathogen Safety Data Sheets
Clostridium difficile, of the Clostridiaceae family, is motile, anaerobic, and spore-forming (forms subterminal spores)
A phase 3 study evaluating the lot consistency ...
Three doses (Months 0,1,6) of toxoid-based C difficile vaccine induced robust neutralizing antibody responses and were well tolerated in healthy participants ...
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