NCT02538185

Intradermal Rabies Immunization Using NanoJect: A Comparative Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.

Detailed description

This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each volunteer will receive three injections at each of three vaccination visits. Total study duration per volunteer is 2 months.

Conditions

• Intradermal (ID) Vaccination Device

Interventions

Type	Name	Description
DEVICE	NanoJect device (DebioJect™)	The investigational device used in this study is the NanoJect™ device developed by Debiotech company.
DEVICE	Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus)	The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus)
DEVICE	Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)	The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)
DRUG	Vaccin rabique Pasteur®
DRUG	Placebo	Sodium Chloride (NaCl) 0,9%; B. Braun

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2015-09-02
• Last updated: 2020-03-26