Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults


Brief Summary

It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.

Intervention / Treatment

    single dose intranasal administration of GHB04L1
  • Placebo (OTHER)
    SPGN buffer

Condition or Disease

  • Influenza


Study Design

Status: Completed
Study results: No Results Available
Age: 18 Years to 50 Years
Enrollment: 32 (ACTUAL)
Funded by: Industry|Other
Allocation: Randomized
Primary Purpose: Prevention


Clinical Trial Dates

Start date: Aug 01, 2008
Primary Completion: Dec 01, 2009 ACTUAL
Completion Date: Mar 01, 2010 ACTUAL
Study First Posted: Aug 26, 2008 ESTIMATED
Last Updated: Mar 01, 2010

Sponsors / Collaborators

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


Eligibility Criteria

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

Inclusion Criteria:

* Healthy male volunteers, 18-50 years
* Seronegative for H5N1
* Seronegative for H1N1 (with antibody titers ≤1:20)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness
* Signs of acute or chronic upper or lower tract respiratory illnesses
* History of severe atopy
* Seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against H5N1
* 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
* 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
  • To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus. study medication administration until 30 days after end of study
Secondary Outcomes
  • To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally. day1 until day 29

More Details

NCT Number: NCT00741806
Acronym: GHB-CS03
Other IDs: GHB-CS03
Study URL:
Last updated: Sep 29, 2023