Clinical trial NCT00741806: Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Official title: Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: vaccination
avian
Lead sponsor: AVIR Green Hills Biotechnology AG
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Vienna
First posted: 2008-08-26
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus.
timeFrame: study medication administration until 30 days after end of study
Secondary outcomes:
measure: To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.
timeFrame: day1 until day 29
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept of Clinical Pharmacology, Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Volker Wacheck, MD
role: PRINCIPAL_INVESTIGATOR
References: