Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

NCT ID: NCT00741806

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GHB04L1

Single dose, dose escalation

Group Type: EXPERIMENTAL

GHB04L1

Intervention Type: BIOLOGICAL

single dose intranasal administration of GHB04L1

SPGN buffer

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

SPGN buffer

Interventions

GHB04L1

single dose intranasal administration of GHB04L1

Intervention Type: BIOLOGICAL

Placebo

SPGN buffer

Intervention Type: OTHER

Other Intervention Names

A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

AVIR Green Hills Biotechnology AG

INDUSTRY

Sponsor Role: lead

Responsible Party

AVIR Green Hills Biotechnology AG

Principal Investigators

Volker Wacheck, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Dept of Clinical Pharmacology, Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

EudraCT 2007-003219-29

Identifier Type: -

Identifier Source: secondary_id

GHB-CS03

Identifier Type: -

Identifier Source: org_study_id