Dose-escalation Study of Single Dose GHB04L1 in Healthy A... | NCT00741806

Studies
Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

NCT00741806

Sponsor

AVIR Green Hills Biotechnology AG

Status

Completed

Last Update Posted

Mar 2, 2010Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Influenza

Interventions

GHB04L1
Placebo

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2007-003219-29

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Name	Class
Medical University of Vienna	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GHB04L1	Experimental	Single dose, dose escalation	Biological: GHB04L1
SPGN buffer	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GHB04L1	Biological	single dose intranasal administration of GHB04L1	GHB04L1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To assess local immune response, systemic immune response and pharmacokinetics (shedding) of a single dose of GHB04L1 aerosol administered intranasally.		day1 until day 29

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections