Seasonal Human Influenza Clinical Trial
— GHBCS-01Official title:
Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
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 performed further to assess local and systemic immune response and to analyse
pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | August 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Vienna, Vienna General Hospital, Dpmt. of Clinical Pharmacology | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| AVIR Green Hills Biotechnology AG |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary objective of safety and tolerability of GHB01L1 administered as single dose intranasal aerosol will be evaluated by clinical signs and symptoms as well as laboratory tests. | Beginning with signing Informed Consent through 30 days after study end | Yes | |
| Secondary | Local immune response: IgA and cytokines response in nasal mucosal samples. Systemic Immune response: HAI, MNA and IgG assessment in serum samples. Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples. | Samples are collected at baseline and at several time points till day 29 (end of study) | Yes |