Dose Finding Study of Single Dose GHB11L1 in Healthy Adults (GHB-CS07)

This study has been completed.
Sponsor:
Information provided by:
AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier:
NCT01078701
First received: March 1, 2010
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Influenza, Human
Biological: GHB11L1
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

Resource links provided by NLM:


Further study details as provided by AVIR Green Hills Biotechnology AG:

Primary Outcome Measures:
  • Local and systemic immune response [ Time Frame: From baseline to day 29 (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples. [ Time Frame: From written informed consent to 30 days after end of study ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GHB11L1
Dose levels: 6.0 log10 TCID50/volunteer, 6.5 log10 TCID50/volunteer and 7.0 log10 TCID50/volunteer
Biological: GHB11L1
GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
Other Name: A/Brisbane/59/07(H1N1)-like delNS1 virus reassortant
Placebo Comparator: SPGN buffer
SPGN buffer administration by liquid nasal spray
Biological: Placebo
SPGN buffer
Other Name: SPGN buffer

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078701

Locations
Austria
Medical University Vienna, Department of Clinical Pharmacology
Vienna, Austria, A-1090
Sponsors and Collaborators
AVIR Green Hills Biotechnology AG
Investigators
Principal Investigator: Volker Wacheck, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Thomas Muster PhD, CEO/CSO, AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier: NCT01078701     History of Changes
Other Study ID Numbers: GHB-CS07, EudraCT 2009-015902-20
Study First Received: March 1, 2010
Last Updated: January 4, 2011
Health Authority: Austria: Federal Ministry for Health Family and Youth

Keywords provided by AVIR Green Hills Biotechnology AG:
live attenuated flu vaccines
Influenza A (H1N1)
intranasal application
replication-deficient influenza virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014