NCT02388009

Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a

Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.

Detailed description

A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group. For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.

Conditions

• Shigellosis

Interventions

Type	Name	Description
BIOLOGICAL	Flexyn2a	Intramuscular doses of 0.5 mL
BIOLOGICAL	Placebo	Intramuscular doses of 0.5 mL
BIOLOGICAL	Flexyn2a plus adjuvant	Intramuscular doses of 0.5 mL

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2015-03-13
• Last updated: 2015-12-22

Locations

1 site across 1 country: United States