NCT02646371

Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a

Phase 2b, Double-blind, Placebo-controlled Efficacy Challenge Study With a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.

Detailed description

Flexyn2a is a bioconjugate candidate vaccine that is able to induce an humoral immune response specific for the 2a-antigen of Shigella flexneri 2a bacteria. Healthy adult volunteers naïve for Shigella flexneri 2a infections at screening will receive two administrations of 10 micrograms Flexyn2a or placebo 4 weeks apart. Four weeks after the second vaccination, each subject will be challenged with 1500 cfu of the virulent Shigella flexneri 2a strain 2457T. In order to assess the ability of Flexyn2a to protect against infection with this strain, the attack rate of shigellosis in the group vaccinated with Flexyn2a will be compared to the group of the subjects who received placebo injections.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Flexyn2a	2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
BIOLOGICAL	Placebo	2 doses of TBS solution will be injected intramuscularly 4 weeks apart

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-09-01
• Completion: 2017-07-01
• First posted: 2016-01-05
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

1 site across 1 country: United States