Clinical trial NCT01078701: Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Official title: Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
Keywords: live attenuated flu vaccines
Influenza A (H1N1)
intranasal application
replication-deficient influenza virus
Lead sponsor: AVIR Green Hills Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 49
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: The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.

This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

Detailed description: GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo.

Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised.

GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 18-50 years
* Seronegative for H1N1 (Influenza A/Brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness (\>37.0°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time
* 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

Primary outcomes:
measure: Local and systemic immune response
timeFrame: From baseline to day 29 (end of study)
Secondary outcomes:
measure: Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples.
timeFrame: From written informed consent to 30 days after end of study
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: Medical University Vienna
name: Volker Wacheck, MD
role: PRINCIPAL_INVESTIGATOR
References: