Influenza, HumanPhase 1/2NCT01369862
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
A Phase 1/2 study testing GHB16L2 in people with Influenza, Human, run by AVIR Green Hills Biotechnology AG at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GHB16L2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
Official title: 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).
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- GHB16L2, Placebo
- Keywords
- live attenuated flu vaccines, influenza A (H1N1), intranasal application, replication-deficient influenza virus
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHB16L2Biological
A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
PlaceboBiological
SPGNH buffer
| Study group | Role | What they receive |
|---|---|---|
| SPGNH buffer | Placebo comparator | SPGNH buffer administration by liquid nasal spray Receives: Biological: Placebo |
| GHB16L2 | Experimental | Dose level ~7.0 log10 fTCID50/strain/person Receives: Biological: GHB16L2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Measured: From baseline to 30 days after end of study
Secondary outcomes (3)
Seroconversion rates at day 29
Seroconversion rates for HAI, MNA, IgA and IgG
Measured: At day 29 (end of study)
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
Measured: 1 week post immunisation
Immune response factor at day 29
Immune response factors for HAI, MNA, IgA and IgG
Measured: At day 29 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVIR Green Hills Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Wolzt, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369862
- Sponsor's protocol ID
- GHB-CS08
- Status last verified
- Aug 2011
- First submitted
- 4 Jan 2011
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24183981
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT01369862
- Acronym / sponsor ID
- GHB-CS08
- Conditions
- Influenza, Human
- Keywords
- live attenuated flu vaccines, influenza A (H1N1), intranasal application, replication-deficient influenza virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AVIR Green Hills Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPGNH buffer | Placebo comparator | Biological: PlaceboSPGNH buffer administration by liquid nasal spray |
| GHB16L2 | Experimental | Biological: GHB16L2Dose level ~7.0 log10 fTCID50/strain/person |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHB16L2A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants | Biological | GHB16L2 |
| PlaceboSPGNH buffer | Biological | SPGNH buffer |
Primary outcome
Number of participants with Adverse Events
Time frame: From baseline to 30 days after end of study
3 secondary outcomes
Seroconversion rates at day 29
Time frame: At day 29 (end of study)
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)
Time frame: 1 week post immunisation
Immune response factor at day 29
Time frame: At day 29 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 24183981Mossler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolzt, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GHB16L2 in people with Influenza, Human, run by AVIR Green Hills Biotechnology AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: From baseline to 30 days after end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01369862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.