Influenza, Human
Conditions
Keywords
live attenuated flu vaccines, influenza A (H1N1), intranasal application, replication-deficient influenza virus
Brief summary
The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).
Detailed description
GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
Interventions
BIOLOGICALGHB16L2
A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
BIOLOGICALPlacebo
SPGNH 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
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers, 18-60 years * Seronegative for one or two of the applied vaccine strains * Low antibody titres 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
Exclusion criteria
* Acute febrile illness (\>37.3°C) * Signs of acute or chronic upper or lower tract respiratory illnesses * 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 * 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 |
|---|---|
| Number of participants with Adverse Events | From baseline to 30 days after end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates at day 29 | At day 29 (end of study) | Seroconversion rates for HAI, MNA, IgA and IgG |
| Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding) | 1 week post immunisation | — |
| Immune response factor at day 29 | At day 29 (end of study) | Immune response factors for HAI, MNA, IgA and IgG |
Countries
Austria
Outcome results
None listed