Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults

Summary

This Phase I, first-in-human study is intended to primarily determine the safety of the dose range with or without Aluminum phosphate adjuvant expected to be needed for later clinical studies, to determine the nature of adverse reactions (i.e., safety profile) and to secondly assess the Aluminum phosphate humoral immune responses in non-endemic population to guide future dose selection.

Timeline

Start

2022-12-05

Primary completion

2023-09-08

Completion

2024-01-23

Publications

• Kelly M, Janardhanan J, Wagh C, Verma S, Charles RC, Leung DT, Kamruzzaman M, Pansuriya RK, Chowdhury F, Vann WF, Kaminski RW, Khan AI, Bhuiyan TR, Qadri F, Kovac P, Xu P, Ryan ET. Development of a Shigella conjugate vaccine targeting Shigella flexneri 6 that is immunogenic and provides protection against virulent challenge. Vaccine. 2024 Oct 24;42(24):126263. doi: 10.1016/j.vaccine.2024.126263. Epub 2024 Aug 31.
• Kelly M, Jeon S, Yun J, Lee B, Park M, Whang Y, Lee C, Charles RC, Bhuiyan TR, Qadri F, Kamruzzaman M, Cho S, Vann WF, Xu P, Kovac P, Ganapathy R, Lynch J, Ryan ET. Vaccination of Rabbits with a Cholera Conjugate Vaccine Comprising O-Specific Polysaccharide and a Recombinant Fragment of Tetanus Toxin Heavy Chain Induces Protective Immune Responses against Vibrio cholerae O1. Am J Trop Med Hyg. 2023 Oct 2;109(5):1122-1128. doi: 10.4269/ajtmh.23-0259. Print 2023 Nov 1.

Drugs

Indications

No indication recorded.