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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014