NCT01069471

Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

Safety and Reactogenicity of a Candidate Vaccine Against S. Dysenteriae When Administered to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlycoVaxyn AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1. Blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Shigella vaccine	Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-02-17
• Last updated: 2010-10-13

Locations

1 site across 1 country: Switzerland