CVD 909 Vi Prime Boost Study

Summary

The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.

Timeline

Start

2006-02

Primary completion

2007-09

Completion

2008-08

Publications

• Background Wahid R, Zafar SJ, McArthur MA, Pasetti MF, Levine MM, Sztein MB. Live oral Salmonella enterica serovar Typhi vaccines Ty21a and CVD 909 induce opsonophagocytic functional antibodies in humans that cross-react with S. Paratyphi A and S. Paratyphi B. Clin Vaccine Immunol. 2014 Mar;21(3):427-34. doi: 10.1128/CVI.00786-13. Epub 2014 Jan 15.

Drugs

Indications