Penn State Health Milton S. Hershey Medical Center Hershey, PA
Muhammad Shahzil, MD1, Saleha Azeem, 2, Zainab Jamil, 2, Ammad Javaid Chaudhry, MD3, Aisha Shabbir, MD4, Maria Rehmani, 2, Muhammad Saad Faisal, MD3, Muhammad Ali Khaqan, MD5, Muhammad Sheharyar Warraich, MD6 1Penn State Health Milton S. Hershey Medical Center, Hershey, PA; 2King Edward Medical University, Lahore, Punjab, Pakistan; 3Henry Ford Health, Detroit, MI; 4University of Minnesota, Minneapolis, MN; 5John H. Stroger, Jr. Hospital of Cook County, Chicago, IL; 6University of Illinois College of Medicine, Peoria, IL
Introduction:
Clostridium 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, eight 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.
Discussion:
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.
Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.
Disclosures:
Muhammad Shahzil indicated no relevant financial relationships.
Saleha Azeem indicated no relevant financial relationships.
Zainab Jamil indicated no relevant financial relationships.
Ammad Javaid Chaudhry indicated no relevant financial relationships.
Aisha Shabbir indicated no relevant financial relationships.
Maria Rehmani indicated no relevant financial relationships.
Muhammad Saad Faisal indicated no relevant financial relationships.
Muhammad Ali Khaqan indicated no relevant financial relationships.
Muhammad Sheharyar Warraich indicated no relevant financial relationships.
Muhammad Shahzil, MD1, Saleha Azeem, 2, Zainab Jamil, 2, Ammad Javaid Chaudhry, MD3, Aisha Shabbir, MD4, Maria Rehmani, 2, Muhammad Saad Faisal, MD3, Muhammad Ali Khaqan, MD5, Muhammad Sheharyar Warraich, MD6. P3625 - Comprehensive Evaluation of the Efficacy and Safety of the <i>Clostridioides difficile</i> Toxoid Vaccine: A Meta-Analysis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
