Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

Summary

This is a Phase I, Randomized, observer-blinded, age de-escalating study. The study objectives are: 1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks. 2. To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks. 3. To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.

Timeline

Start

2016-05-19

Primary completion

2017-02-09

Completion

2017-02-09

Publications

• Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo SK, Chon Y, Kothari S, Yang SY, Ham DS, Ryu JH, Hwang HS, Mun JH, Lynch JA, Kim JH, Kim H, Excler JL, Sahastrabuddhe S. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine. 2018 Jun 18;36(26):3794-3801. doi: 10.1016/j.vaccine.2018.05.038.

Drugs

Indications