A phase 1, placebo-controlled, randomized study of the safety, tolerability, and immunogenicity of a Clostridium difficile vaccine administered with or without aluminum hydroxide in healthy adults

• Published in: Vaccine Vol. 34; no. 18; pp. 2082 - 2091
• Main Authors: Sheldon, Eric, Kitchin, Nicholas, Peng, Yahong, Eiden, Joseph, Gruber, William, Johnson, Erik, Jansen, Kathrin U., Pride, Michael W., Pedneault, Louise
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 19.04.2016; Elsevier Limited
• Subjects: Adjuvants, Immunologic - administration & dosage; adults; Age; Aged; Aged, 80 and over; Allergy and Immunology; Aluminum; aluminum hydroxide; Aluminum Hydroxide - administration & dosage; Antibiotics; Antibodies, Bacterial - blood; Antibodies, Neutralizing - blood; antigens; Antitoxins; bacteria; Bacterial Vaccines - administration & dosage; Bacterial Vaccines - therapeutic use; Clostridium difficile; Diarrhea; Enterocolitis, Pseudomembranous - prevention & control; Ethnicity; Female; headache; Hemophilia; Hepatitis; Hispanic Americans; Hospitals; Humans; Illnesses; Immune response; Immunization; Immunization, Secondary; Immunogenicity; Infections; injection site; Laboratories; Long term health care; Long-term care; Male; Middle Aged; morbidity; Mortality; neutralization; neutralizing antibodies; Neutralizing antibody; Nursing; nursing homes; Population; Pseudomembranous colitis; Single-Blind Method; Toxin A; Toxin B; Toxins; toxoids; Toxoids - administration & dosage; Toxoids - therapeutic use; Vaccine; Vaccines; virulence; United States > US; Toxin A; C. difficile; Toxin B; Clostridium difficile; Al(OH)3; CDI; Vaccine; Pseudomembranous colitis; PCR; Neutralizing antibody; Al(OH) 3; aluminum hydroxide; Clostridium difficile infection; polymerase chain reaction

•Phase 1 study of a toxoid A and B vaccine in healthy adults aged 50–85 years.•Immunogenicity was present after Dose 2, with an anamnestic response at Month 7.•Response was higher in the toxoid-only groups than in the Al(OH)3-containing groups.•No clear dose response was evident in either the 50–64-...