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Clinical Trials/NCT00741806
NCT00741806CompletedPhase 1

Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

AVIR Green Hills Biotechnology AG2 sites in 1 country32 target enrollmentStarted: August 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
To evaluate safety and tolerability of GHB04L1 administered as single dose intranasal aerosol for vaccination against influenza A (H5N1) virus.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

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 Outcomes

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

Investigators

Sponsor Class
Industry

Study Sites (2)

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