Back to resultsDose Finding Study of Single Dose GHB11L1 in Healthy Adults (GHB-CS07)
Primary Purpose
Influenza, Human
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
GHB11L1
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring live attenuated flu vaccines, Influenza A (H1N1), intranasal application, replication-deficient influenza virus
Eligibility 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
Sites / Locations
- Medical University Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GHB11L1
SPGN buffer
Arm Description
Dose levels: 6.0 log10 TCID50/volunteer, 6.5 log10 TCID50/volunteer and 7.0 log10 TCID50/volunteer
SPGN buffer administration by liquid nasal spray
Outcomes
Primary Outcome Measures
Local and systemic immune response
Secondary Outcome Measures
Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples.
Full Information
NCT ID
NCT01078701
First Posted
March 1, 2010
Last Updated
January 4, 2011
Sponsor
AVIR Green Hills Biotechnology AG
1. Study Identification
Unique Protocol Identification Number
NCT01078701
Brief Title
Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Acronym
GHB-CS07
Official Title
Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AVIR Green Hills Biotechnology AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
live attenuated flu vaccines, Influenza A (H1N1), intranasal application, replication-deficient influenza virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GHB11L1
Arm Type
Experimental
Arm Description
Dose levels: 6.0 log10 TCID50/volunteer, 6.5 log10 TCID50/volunteer and 7.0 log10 TCID50/volunteer
Arm Title
SPGN buffer
Arm Type
Placebo Comparator
Arm Description
SPGN buffer administration by liquid nasal spray
Intervention Type
Biological
Intervention Name(s)
GHB11L1
Other Intervention Name(s)
A/Brisbane/59/07(H1N1)-like delNS1 virus reassortant
Intervention Description
GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
SPGN buffer
Intervention Description
SPGN buffer
Primary Outcome Measure Information:
Title
Local and systemic immune response
Time Frame
From baseline to day 29 (end of study)
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Wacheck, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
12. IPD Sharing Statement
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Dose Finding Study of Single Dose GHB11L1 in Healthy Adults
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