NCT01369862CompletedPhase 1
Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
AVIR Green Hills Biotechnology AG1 site in 1 country80 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
SPGNH buffer
Placebo Comparator
SPGNH buffer administration by liquid nasal spray
Intervention: Placebo (Biological)
GHB16L2
Experimental
Dose level ~7.0 log10 fTCID50/strain/person
Intervention: GHB16L2 (Biological)
Outcomes
Primary Outcomes
Number of participants with Adverse Events
Time Frame: From baseline to 30 days after end of study
Secondary Outcomes
- Seroconversion rates at day 29(At day 29 (end of study))
- 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))
Investigators
Study Sites (1)
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