Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

Influenza, Human Clinical Trial

— GHB-CS07  

Official title:

Randomised, Double-blind, Placebo-controlled, Phase IIa Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078701
• Other study ID #: GHB-CS07
• Secondary ID: EudraCT 2009-015
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2010
• Last updated: January 4, 2011
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2011
• Source: AVIR Green Hills Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health Family and Youth
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• GHB11L1
GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
• Placebo
SPGN buffer

Locations

Country	Name	City	State
Austria	Medical University Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
AVIR Green Hills Biotechnology AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic immune response		From baseline to day 29 (end of study)	No
Secondary	Clinical signs and symptoms, laboratory tests Pharmacokinetics: qualitative assessment of viral recovery (shedding) in nasal mucosal samples.		From written informed consent to 30 days after end of study	Yes