Dose Finding Study of Single Dose GHB11L1 in Healthy Adults


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.

Intervention / Treatment

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

Condition or Disease

  • Influenza, Human


Study Design

Status: Completed
Study results: No Results Available
Age: 18 Years to 50 Years
Enrollment: 49 (ACTUAL)
Funded by: Industry
Allocation: Randomized
Primary Purpose: Prevention


Clinical Trial Dates

Start date: Dec 01, 2009
Primary Completion: May 01, 2010 ACTUAL
Completion Date: May 01, 2010 ACTUAL
Study First Posted: Mar 02, 2010 ESTIMATED
Last Updated: Jan 04, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A


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 Criteria

Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: Yes

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

Primary Outcomes
  • Local and systemic immune response From baseline to day 29 (end of study)
Secondary Outcomes
  • 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

More Details

NCT Number: NCT01078701
Acronym: GHB-CS07
Other IDs: GHB-CS07
Study URL:
Last updated: Sep 29, 2023