Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

Phase 1

Completed

• Conditions: Influenza

• Registration Number: NCT00741806
• Lead Sponsor: AVIR Green Hills Biotechnology AG

Brief Summary

It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Primary Completion: 2009-12
• Status Verified: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Healthy male volunteers, 18-50 years
• Seronegative for H5N1
• Seronegative for H1N1 (with antibody titers ≤1:20)
• Written informed consent to participate in this study

Exclusion Criteria

• Acute febrile illness
• Signs of acute or chronic upper or lower tract respiratory illnesses
• History of severe atopy
• Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
• Known increased tendency of nose bleeding
• Volunteers with clinically relevant abnormal paranasal anatomy
• Volunteers with clinically relevant abnormal laboratory values
• Simultaneous treatment with immunosuppressive drugs
• Clinically relevant history of renal, hepatic, GI, cardiovascular,haematological, skin, endocrine, neurological or immunological diseases
• History of leukaemia or cancer
• HIV or Hepatitis B or C seropositivity
• Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
• Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
• Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
• Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus.	study medication administration until 30 days after end of study

Secondary Outcome Measures

Name	Time	Method
To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.	day1 until day 29

Trial Locations

Locations (1)

Dept of Clinical Pharmacology, Medical University Vienna; 🇦🇹 Vienna, Austria