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

This study has been completed.
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by:
AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00741806
First received: August 25, 2008
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Influenza
Biological: GHB04L1
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AVIR Green Hills Biotechnology AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741806

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

No publications provided

Responsible Party: AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier: NCT00741806     History of Changes
Other Study ID Numbers: GHB-CS03, EudraCT 2007-003219-29
Study First Received: August 25, 2008
Last Updated: March 1, 2010
Health Authority: Austria: Austrian Agency for Health and Food Safety (AGES)

Keywords provided by AVIR Green Hills Biotechnology AG:
vaccination
avian

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014