Status:
COMPLETED
Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
Lead Sponsor:
AVIR Green Hills Biotechnology AG
Conditions:
Seasonal Human Influenza
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus. This study is perf...
Detailed Description
GHB01L1 intends to provide a novel vaccination for influenza virus infection. Data indicate that the GHB01L1 virus is a promising, safe and immunogenic vaccine candidate with a high protection efficac...
Eligibility Criteria
Inclusion
- Healthy male volunteers, 18-50 years
- Immune status: seronegative with respect to the applied virus antigens with antibody titres \<1:10 detected in the HAI assay with the corresponding antigens)
- Written informed consent to participate in this study
Exclusion
- Acute febrile illness (\>37.3°C)
- Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
- History of severe atopy
- Seasonal influenza vaccination 2005/2006, 2006/2007 and/or 2007/2008 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 incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
- 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 :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00724997
Start Date
March 1 2007
End Date
August 1 2008
Last Update
December 8 2009
Active Locations (1)
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1
Medical University Vienna, Vienna General Hospital, Dpmt. of Clinical Pharmacology
Vienna, Austria, A-1090