Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

NCT00741806 | Completed Phase 1 DMC

• 2 other identifiers: GHB-CS03EudraCT 2007-003219-29
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

vaccination; avian

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.

  day1 until day 29

Study Arms (2)

GHB04L1

EXPERIMENTAL

Single dose, dose escalation

Biological: GHB04L1

SPGN buffer

PLACEBO COMPARATOR

Other: Placebo

Interventions

GHB04L1 BIOLOGICAL

single dose intranasal administration of GHB04L1

Also known as: A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant

GHB04L1

Placebo OTHER

SPGN buffer

SPGN buffer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AVIR Green Hills Biotechnology AG: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Dept of Clinical Pharmacology, Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Volker Wacheck, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

AU (1)