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Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults (GHB-CS03)

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ClinicalTrials.gov Identifier: NCT00741806
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : March 2, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: GHB04L1 Other: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Study Start Date : August 2008
Primary Completion Date : December 2009
Study Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: GHB04L1
Single dose, dose escalation
Biological: GHB04L1
single dose intranasal administration of GHB04L1
Other Name: A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant
Placebo Comparator: SPGN buffer Other: Placebo
SPGN buffer

Outcome Measures

Primary Outcome Measures :
  1. To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus. [ Time Frame: study medication administration until 30 days after end of study ]

Secondary Outcome Measures :
  1. To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally. [ Time Frame: day1 until day 29 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741806

Dept of Clinical Pharmacology, Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
AVIR Green Hills Biotechnology AG
Medical University of Vienna
Principal Investigator: Volker Wacheck, MD Medical University of Vienna
More Information

Responsible Party: AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier: NCT00741806     History of Changes
Other Study ID Numbers: GHB-CS03
EudraCT 2007-003219-29
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by AVIR Green Hills Biotechnology AG: