Hackensack Meridian Health Joins Phase 3 Trial of Pfizer’s Investigational C difficile Vaccine

Hackensack Meridian Health has become one of the largest participating health systems in Pfizer's global Phase 3 BEETHOVEN clinical trial, which is evaluating an investigational vaccine to prevent Clostridioides difficile (C diff) infection in adults aged 65 years and older. Through the Hackensack Meridian Health Research Institute, investigators at Hackensack University Medical Center and Jersey Shore University Medical Center plan to enroll approximately 1,000 participants, making it the largest clinical trial ever conducted across the health network.

The randomized, double-blind, placebo-controlled BEETHOVEN study is enrolling approximately 32,000 participants at more than 129 sites across four countries to assess the safety, tolerability, and efficacy of a two-dose adjuvanted vaccine in reducing primary C diff infections. Participants will receive two doses over six months and be followed for 3.5 years through electronic health diaries and routine assessments to monitor infections, medications, and overall health.

Bindu Balani, MD, associate professor of Internal Medicine at the Hackensack Meridian School of Medicine and affiliate associate member of the Center for Discovery and Innovation, is the principal investigator at HUMC and she will be working with Ashley Eunhye Kang, MD, and Arunima Sarkar, MD. At Jersey Shore University Medical Center, Anna Kufelnicka,, MD, Jose Fune, MD, and Alex Lazo-Vasquez, MD, will be the sub-investigators overseeing the study.

Lazo-Vasquez infectious diseases specialist at Jersey Shore University Medical Center who is an investigator on the trial spoke to Contagion about the study.

Contagion: Why is there an urgent need for a vaccine targeting C. diff, particularly among adults aged 65 and older and patients frequently exposed to hospitals or antibiotics?

Lazo-Vasquez: The clinical need for a C diff vaccine is huge, especially as modern medicine advances. C diff causes around 500,000 infections a year, and it carries a high mortality rate, where roughly 1 in 11 infected patients over age 65 die. We also have to face the fact that C diff is changing. It used to be known strictly as an intrahospital infection, but nowadays we routinely see it occurring right in the community because so many people are now colonized with it. Right now, our treatment options are highly limited.

Contagion: Can you explain how the phase 3 BEETHOVEN trial is structured, including the vaccine regimen, participant follow-up, and the goals researchers hope to achieve over the 3.5-year study period?

Lazo-Vasquez: The Phase 3 BEETHOVEN trial is structured to evaluate exactly that. Participants are randomized 1:1 to receive a simplified two-dose regimen of either the investigational adjuvanted vaccine or a saline placebo. Patients will be followed for a period of time. If a patient becomes symptomatic with a potential C diff infection, stool samples are sent to confirm the presence of the toxin. The primary goal is: to evaluate how effective, safe, and tolerable the vaccine is at reducing primary C diff infections, starting 14 days after that second dose.

Contagion: What impact could a successful C diff vaccine have on infection prevention practices in hospitals, nursing homes, and other health care environments?

Lazo-Vasquez: Successfully preventing cases of C diff infection could save, and improve, lives. According to the CDC [Centers for Disease Control and Prevention], 1 in 6 people who are infected will become re-infected. Finding a way to break that kind of illness cycle is a major objective for clinicians in every care setting.

Reference
Hackensack Meridian Health Joins Massive Clinical Trial to Vaccinate Against Health Care Infection.Hackensack press release. April 10, 2026. Accessed June 28, 2026.
https://www.hackensackmeridianhealth.org/en/news/2026/04/10/hmh-joins-massive-clinical-trial-to-vaccinate-against-health-care-infection