Status:
COMPLETED
Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Lead Sponsor:
AVIR Green Hills Biotechnology AG
Collaborating Sponsors:
Medical University of Vienna
Conditions:
Influenza
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 random...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00741806
Start Date
August 1 2008
End Date
March 1 2010
Last Update
March 2 2010
Active Locations (1)
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1
Dept of Clinical Pharmacology, Medical University Vienna
Vienna, Austria, 1090