Influenza Clinical Trial
— GHB-CS03Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Dept of Clinical Pharmacology, Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
AVIR Green Hills Biotechnology AG | Medical University of Vienna |
Austria,
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 |
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