Clostridium Difficile Vaccine Efficacy Trial

Summary

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Timeline

Start

2017-03-29

Primary completion

2021-12-21

Completion

2021-12-21

Outcome

Missed primary endpoint

paper The primary end point was not met PMID 39180325 ↗

registry Vaccine efficacy 31.0 (96.4% CI -38.7 to 66.6) NCT03090191 ↗

Publications

• Donskey CJ, Dubberke ER, Klein NP, Liles EG, Szymkowiak K, Wilcox MH, Lawrence J, Bouguermouh S, Zhang H, Koury K, Bailey R, Smith HM, Lockhart S, Lamberth E, Kalina WV, Pride MW, Webber C, Anderson AS, Jansen KU, Gruber WC, Kitchin N. CLOVER (CLOstridium difficile Vaccine Efficacy tRial) Study: A Phase 3, Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection. Clin Infect Dis. 2024 Dec 17;79(6):1503-1511. doi: 10.1093/cid/ciae410.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-06425090	Vaccine	—	—

Indications