Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Biological: GHB04L1
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GHB04L1<br>Single dose, dose escalation | Biological: GHB04L1<br>* single dose intranasal administration of GHB04L1<br>* Other names: A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant;|
| Placebo Comparator: SPGN buffer<br> | Other: Placebo<br>* SPGN buffer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally. |  | day1 until day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, avian