Influenza, Human
Conditions
Keywords
live attenuated flu vaccines, Influenza A (H1N1), intranasal application, replication-deficient influenza virus
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.
Interventions
BIOLOGICALGHB11L1
GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
BIOLOGICALPlacebo
SPGN buffer
Sponsors
AVIR Green Hills Biotechnology AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local and systemic immune response | From baseline to day 29 (end of study) |
Secondary
| Measure | Time frame |
|---|---|
| Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples. | From written informed consent to 30 days after end of study |
Countries
Austria
Outcome results
None listed