Study Title and Description
Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.
Key Questions Addressed
|8||Key Question 8 - Case studies/series and potential harms of nonstandard interventions for CDI|
Primary Publication Information
|Title||Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.|
|Author||Kotloff KL., Wasserman SS., Losonsky GA., Thomas W., Nichols R., Edelman R., Bridwell M., Monath TP.|
|Country||Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. firstname.lastname@example.org|
Pubmed ID: 11159994
Secondary Publication Information
There are currently no secondary publications defined for this study.
Extraction Form: Key Question 4 - Case studies/series and potential harms of nonstandard interventions for CDI (Table C11)
|Question... Follow Up||Answer||Follow-up Answer|
|Study Focus||Randomized, double- blind, Phase 1 study of C. difficile vaccine|
|Subject/Study Details||30 healthy adults (no ages reported)|
|Interventions||Vaccine, 6.25, 25 or 100 mg given intramuscular Five subjects at each dose level received soluble toxoid vaccine, and five subjects received an equivalent dose of toxoid adsorbed to alum.|
|Clinical Diarrhea Outcomes|
|C. difficile Toxin, C. difficile Culture, or Other|
|Adverse Effects (AE) Harms||No serious adverse events during the study: rash = 8 (subjects); abdominal pain = 6; athralgia = 2; diarrhea = 2 All subjects had local pain at injection site, especially those who received toxoid adsorbed to alum, pruritus (without urticaria) at the site of injection n = 6|
Results & Comparisons
No Results found.