Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

Influenza Clinical Trial

— GHB-CS03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741806
• Other study ID #: GHB-CS03
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2008
• Last updated: March 1, 2010
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: AVIR Green Hills Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Agency for Health and Food Safety (AGES)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• GHB04L1
single dose intranasal administration of GHB04L1

Other:
• Placebo
SPGN buffer

Locations

Country	Name	City	State
Austria	Dept of Clinical Pharmacology, Medical University Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
AVIR Green Hills Biotechnology AG	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.		day1 until day 29	No