Comprehensive Evaluation of the Efficacy and Safety of the Clostridioides difficile Toxoid Vaccine: A Meta-Analysis

Document Type

Conference Proceeding

Publication Date

10-1-2024

Publication Title

Am J Gastroenterol

Abstract

Introduction: Clostridioides difficile (C. difficile), a gram-positive bacterium, causes significant morbidity and mortality, particularly in hospitalized individuals over 65 and those recently on antibiotics. Current treatments include antibiotics and fecal transplants for recurrent cases. Given the role of humoral immunity, toxoid vaccines targeting toxins A (TcdA) and B (TcdB) show promise. This meta-analysis evaluates the safety, immunogenicity, and efficacy of the C. difficile toxoid vaccine. Methods: This meta-analysis followed Cochrane and PRISMA guidelines, comparing the efficacy of C. difficile toxoid vaccine (50, 100, and 200 ug doses) against a normal saline placebo. Comprehensive searches were conducted across PubMed, Embase, Scopus, and Cochrane CENTRAL databases up to January 2023, focusing on randomized controlled trials (RCTs). Data extraction adhered to PICOS criteria and utilized Excel. Statistical analyses were performed with RevMan using a random-effects model (P < 0.05). Results: From 3,057 screened studies, 8 were eligible, including 11,717 patients (7903 vaccine and 3814 placebo). Six studies in the day regimen showed significant increases in Geometric Mean Concentrations (GMC) for Toxin A (MD: 2048.05) and Toxin B (MD: 2453.98), and significant seroconversion rates for Toxin A (RR: 23.28) and Toxin B (RR: 19.23). Local adverse effects included increased pain (RR: 3.02), swelling (RR: 8.53), and erythema (RR: 6.78). The 100ug month regimen showed significant GMC increases for Toxin A (MD: 935.01) and Toxin B (MD: 3995.16), with increased pain (RR: 5.39), swelling (RR: 4.91), and erythema (RR: 4.17). The 200ug month regimen showed significant GMC increases for Toxin A (MD: 1246.80) and Toxin B (MD: 6700.23), with elevated seroconversion rates for Toxin A (MD: 77.97) and Toxin B (MD: 66.59). Local adverse effects included increased pain (RR: 5.46), swelling (RR: 4.02), and erythema (RR: 2.69). Systemic adverse effects varied, with some increases in headache and myalgia but overall manageable side effects. Conclusion: This meta-analysis shows that the C. difficile toxoid vaccine elicits robust immune responses and maintains a favorable safety profile across dosages. Despite some variability and evidence quality limitations, the vaccine shows promise in preventing CDI by targeting toxins A and B. Further research is needed to translate immunogenicity into clinical benefits, paving the way for an effective CDI vaccine. (Table Presented).

Volume

119

Issue

10

First Page

S233

Last Page

S234

Find It @ Sladen

Share

COinS