The intended indication for the IMP GHB16L2 is prevention of influenza A (H1N1, H3N2) and B contained in the vaccine.
Conditions
Interventions
Product Name: GHB16L2
Product Code: GHB16L2
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of administration of the placebo: Intranasal use (Noncurrent)
Sponsors
AVIR Green Hills Biotechnology Research Development Trade AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy male and female volunteers, 18-60 years • Seronegative for one or two of the applied vaccine strains (with antibody titres =1:16 detected in micro-HAI assay for influenza A/Brisbane/59/07(H1N1), A/Brisbane/10/07(H3N2) and/or B/Florida/04/06 • Low antibody titres (i.e. titres =1:64 detected in micro-HAI assay) for H1N1v • Written informed consent to participate in this study • For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices (hysterectomy or bilateral tubal ligation, oral or implanted contraceptive use, intrauterine device, barrier method plus spermicide, history of a single male partner with vasectomy, or a history of abstinence deemed credible by the investigator). Note: The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy tests. Are the trial subjects under 18? no Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute febrile illness (>37.3°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 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time • Fever =38.0°C in the time period between the pre-screening visit and day 1 • Known increased tendency of nose bleeding • Volunteers with clinically relevant abnormal paranasal anatomy • Volunteers with clinically relevant abnormal laboratory values • In female volunteers of childbearing potential, a positive urine pregnancy test • 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 4 weeks prior to study medication application • Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of single dose of GHB16L2;Secondary Objective: To assess - immunogenicity (HAI, MNA, SRH, IgA, Granzyme B T-cell response) - pharmacokinetics (shedding);Primary end point(s): The primary end point is to assess the safety and tolerability of GHB16L2 administered as a single dose liquid nasal spray against influenza A (H1N1, H3N2) and B virus. For this purpose 80 healthy volunteers are planned to be included in a phase I/II study where a first group of 18 volunteers and consecutively a second group of 62 volunteers will be randomized in a ratio of 1:1 for verum or placebo in parallel. The second group of 62 will only be included after the safety observation period and an interim safety review for the first group of 18 has been completed.;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the immunogenicity (HAI, MNA, SRH, IgA, IgG and Granzyme B T-cell response) and pharmrcokinetics of GHB16L2 administered as a single dose liquid nasal spray against influenza A (H1N1, H3N2) and B virus.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Austria
Contacts
Public ContactSponsor
AVIR Green Hills Biotechnoligy AG
Outcome results
None listed