NCT01354379

Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer

A Phase 1 Randomized, Observer-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: NanoBio Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the safety and immune response of a new intranasal vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising results in terms of being well tolerated and eliciting mucosal and systemic immune responses after administration by a dropper. In this study NB-1008 is being administered by dropper as well as a nasal sprayer to determine if the sprayer further enhances the immune response.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	NB-1008	NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant.
BIOLOGICAL	Fluzone IN	The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA).

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2011-05-16
• Last updated: 2013-03-28

Locations

1 site across 1 country: United States