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Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine

by: Richard N. Greenberg, Thomas C. Marbury, Ginamarie Foglia, Michel Warny
Vaccine, Vol. 30, No. 13. (March 2012), pp. 2245-2249, doi:10.1016/j.vaccine.2012.01.065  Key: citeulike:10366643

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Abstract

Fifty healthy adult (18–55 years) and 48 elderly (≥65 years) volunteers were randomized to receive a candidate Clostridium difficile toxoid vaccine (2 Î¼g, 10 Î¼g, or 50 Î¼g) or placebo on Days 0, 28, and 56. No volunteer receiving placebo seroconverted. For toxin A, seroconversion by Day 56 (post-dose 2) was observed in 100% of volunteers aged 18–55 years in all dose groups and in 50%, 89%, and 100% of elderly participants in the 2 Î¼g, 10 Î¼g, and 50 Î¼g dose groups, respectively. For both age groups, seroconversion for toxin B was lower than toxin A. There were no safety concerns.


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