Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults (GHB-CS03)

Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: GHB04L1; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Dept of Clinical Pharmacology, Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GHB04L1; Single dose, dose escalation	Biological: GHB04L1; single dose intranasal administration of GHB04L1; Other Names: A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant
Placebo Comparator: SPGN buffer	Other: Placebo; SPGN buffer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: AVIR Green Hills Biotechnology AG
• Collaborators: Medical University of Vienna
• Investigators: Principal Investigator: Volker Wacheck, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 25, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): March 2, 2010
• Last Update Submitted That Met QC Criteria: March 1, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: vaccination; avian
• Other Study ID Numbers: GHB-CS03; EudraCT 2007-003219-29