The End of Toxoid Vaccine Development for Preventing Clostridioides difficile Infections?
Series / Report no.
Open Access
Type
Article
Language
Date
2024-12-31
Research Projects
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Journal Issue
Title
The End of Toxoid Vaccine Development for Preventing Clostridioides difficile Infections?
Translated Title
Published in
Clin Infect Dis 2024; 79(6)1512-1514
Abstract
PF-06425090 is a recombinant detoxified toxin Clostridioides difficile vaccine that was tested in a global, phase 3 efficacy study (CLOVER [CLOstridium difficile Vaccine Efficacy tRial]; NCT03090191) to assess the efficacy in N = 17 535 adults aged 50 years and older at risk for C difficile infection (CDI) [1]. The study was conducted at 382 sites in 23 countries from March 2017 to December 2021 and continued in the coronavirus disease 2019 (COVID-19) period with an altered healthcare system, which resulted in a high dropout rate of 35%. The primary objective of reduction in the incidence of a first primary episode of CDI was not met; however, the results showed that a 3-dose regimen reduced the duration of CDI and the need for CDI-related medical attention and anti-CDI antibiotic treatment. Recurrent infections were also not prevented, although the recurrence numbers were too small to draw firm conclusions. The vaccine was safe and well tolerated, with reported local reactions and systemic events being generally mild to moderate in severity.