Hackensack Meridian Health has joined Pfizer’s Phase 3 BEETHOVEN trial to evaluate an investigational C. difficile vaccine for adults 65 and older, aiming to enroll about 1,000 participants within its network.

A successful vaccine could significantly reduce infections in hospitals, nursing homes, and other healthcare settings by preventing primary infections and potentially breaking cycles of reinfection, given CDC data that infection cycles affect roughly one in six cases.

Participants will receive two doses over six months and be followed for 3.5 years with electronic health diaries and routine assessments to monitor infections, medications, and overall health.

Hackensack University Medical Center and Jersey Shore University Medical Center will host investigators and sub-investigators, with Bindu Balani, MD, serving as PI at HUMC and multiple co-investigators at HUMC and Jersey Shore.

The article references Hackensack Meridian Health’s press release from April 10, 2026, as the source for this information.

The trial uses a 1:1 randomization to vaccine or saline placebo, with symptomatic cases confirmed by stool toxin testing; primary goals are to assess effectiveness, safety, and tolerability starting 14 days after the second dose.

Lazo-Vasquez, MD, an infectious diseases specialist at Jersey Shore University Medical Center, stresses the urgent need for a C. diff vaccine due to about 500,000 U.S. infections annually and notable mortality in patients over 65, with infections increasingly occurring in the community as well as hospitals.

The BEETHOVEN trial is a large, global, randomized, double-blind, placebo-controlled study enrolling roughly 32,000 participants across 129 sites in four countries to evaluate a two-dose adjuvanted vaccine for safety, tolerability, and efficacy.