Hackensack Meridian Health (HMH) recently announced its participation in a massive Phase 3 clinical trial aimed at developing the first vaccine against Clostridioides difficile, commonly known as C. diff.
The investigation, known as the BEETHOVEN study and sponsored by Pfizer, marks the largest-ever clinical trial for the Hackensack Meridian Health Research Institute. Physicians at Hackensack University Medical Center and Jersey Shore University Medical Center are aiming to enroll 1,000 participants as part of a global effort to recruit 32,000 volunteers across four countries.
C. diff is a resilient bacterium that causes severe diarrhea and colitis (inflammation of the colon). According to the CDC, the germ causes approximately 500,000 infections annually in the U.S. and can lead to death, particularly in elderly patients or those with compromised immune systems.
The bacteria are notoriously difficult to eradicate because they form hardy spores that can survive for months on surfaces, in soil, and in clinical environments like hospitals and nursing homes.
“This is a landmark investigation for the healthcare industry, and we are glad to do our part for it,” Dr. Ihor Sawczuk, president of Academics, Research, and Innovation at HMH.
The study is a “double-blinded” and “randomized” trial, meaning neither the participants nor the doctors know who receives the vaccine versus a placebo. The primary goal is to determine if the vaccine can effectively decrease the number of C. diff infections in adults aged 65 and older.
Trial structure:
- Regimen: A two-dose adjuvanted vaccine administered over six months.
- Duration: Participants will be followed for 3.5 years.
- Monitoring: Volunteers will use “e-diaries” to check in and report health changes or medication use.
To participate in the New Jersey sites, volunteers must never have had a C. diff infection previously and must meet one of the following criteria:
- Age 65 or older.
- Received antibiotics in the last three months.
- Hospitalized at least once or had two ER visits in the last year.
- Had 10 or more healthcare visits in the past year.
- Scheduled for an upcoming elective surgery or hospitalization.
The study is being led at Hackensack University Medical Center by Principal Investigator Dr. Bindu Balani, alongside Drs. Ashley Eunhye Kang and Arunima Sarkar. At Jersey Shore University Medical Center, the study is overseen by Drs. Anna Kufelnicka, Jose Fune, and Alex Lazo-Vasquez.
