Back to resultsStudy of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Primary Purpose
Influenza, Human
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
GHB16L2
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 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
Sites / Locations
- Medical University Vienna, Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
SPGNH buffer
GHB16L2
Arm Description
SPGNH buffer administration by liquid nasal spray
Dose level ~7.0 log10 fTCID50/strain/person
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events
Secondary Outcome Measures
Seroconversion rates at day 29
Seroconversion rates for HAI, MNA, IgA and IgG
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
Immune response factor at day 29
Immune response factors for HAI, MNA, IgA and IgG
Full Information
NCT ID
NCT01369862
First Posted
January 4, 2011
Last Updated
January 9, 2014
Sponsor
AVIR Green Hills Biotechnology AG
1. Study Identification
Unique Protocol Identification Number
NCT01369862
Brief Title
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Official Title
Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (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 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.
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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPGNH buffer
Arm Type
Placebo Comparator
Arm Description
SPGNH buffer administration by liquid nasal spray
Arm Title
GHB16L2
Arm Type
Experimental
Arm Description
Dose level ~7.0 log10 fTCID50/strain/person
Intervention Type
Biological
Intervention Name(s)
GHB16L2
Intervention Description
A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
SPGNH buffer
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
From baseline to 30 days after end of study
Secondary Outcome Measure Information:
Title
Seroconversion rates at day 29
Description
Seroconversion rates for HAI, MNA, IgA and IgG
Time Frame
At day 29 (end of study)
Title
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
Time Frame
1 week post immunisation
Title
Immune response factor at day 29
Description
Immune response factors for HAI, MNA, IgA and IgG
Time Frame
At day 29 (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolzt, 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
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
24183981
Citation
Mossler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013 Dec 16;31(52):6194-200. doi: 10.1016/j.vaccine.2013.10.061. Epub 2013 Oct 30.
Results Reference
derived
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Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
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