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Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

This study is currently recruiting participants.
Verified August 2011 by AVIR Green Hills Biotechnology AG
Sponsor:
Information provided by:
AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier:
NCT01369862
First received: January 4, 2011
Last updated: August 11, 2011
Last verified: August 2011
History of Changes

January 4, 2011
August 11, 2011
January 2011
August 2011   (final data collection date for primary outcome measure)
Number of participants with Adverse Events [ Time Frame: From baseline to 30 days after end of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01369862 on ClinicalTrials.gov Archive Site
  • Seroconversion rates at day 29 [ Time Frame: At day 29 (end of study) ] [ Designated as safety issue: No ]
    Seroconversion rates for HAI, MNA, IgA and IgG
  • Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding) [ Time Frame: 1 week post immunisation ] [ Designated as safety issue: Yes ]
  • Immune response factor at day 29 [ Time Frame: At day 29 (end of study) ] [ Designated as safety issue: No ]
    Immune response factors for HAI, MNA, IgA and IgG
Same as current
Not Provided
Not Provided
 
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

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).

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza, Human
  • Biological: GHB16L2
    A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
  • Biological: Placebo
    SPGNH buffer
  • Placebo Comparator: SPGNH buffer
    SPGNH buffer administration by liquid nasal spray
    Intervention: Biological: Placebo
  • Experimental: GHB16L2
    Dose level ~7.0 log10 fTCID50/strain/person
    Intervention: Biological: GHB16L2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Not Provided
Austria
 
NCT01369862
GHB-CS08
No
Thomas Muster PhD, CEO/CSO, AVIR Green Hills Biotechnology AG
AVIR Green Hills Biotechnology AG
Not Provided
Principal Investigator: Michael Wolzt, MD Medical University Vienna
AVIR Green Hills Biotechnology AG
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP