NCT01078701

Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: AVIR Green Hills Biotechnology AG · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus. This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

Detailed description

GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo. Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised. GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	GHB11L1	GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
BIOLOGICAL	Placebo	SPGN buffer

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-02
• Last updated: 2011-01-05

Locations

1 site across 1 country: Austria