Dose Finding Study of Single Dose GHB11L1 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this phase IIa trial is to evaluate the immunogenicity of a single dose of GHB11L1 administered by liquid nasal spray for vaccination against influenza A (H1N1) virus.

This study is also performed to assess safety, tolerability and pharmacokinetics (shedding) of a single dose of GHB11L1 administered by liquid nasal spray.

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Detailed Description

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GHB11L1 intends to provide a novel vaccination for influenza virus infection. 48 healthy volunteers will be included in this phase IIa study investigating three dose levels. 16 subjects will be randomised at a ratio of 3:1 for GHB11L1 or placebo.

Healthy male volunteers, 18-50 years of age and seronegative with respect to the applied virus antigens (antibody titers \<1:10 detected) will be randomised.

GHB11L1 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GHB11L1

Dose levels: 6.0 log10 TCID50/volunteer, 6.5 log10 TCID50/volunteer and 7.0 log10 TCID50/volunteer

Group Type EXPERIMENTAL

GHB11L1

Intervention Type BIOLOGICAL

GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer

SPGN buffer

SPGN buffer administration by liquid nasal spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

SPGN buffer

Interventions

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GHB11L1

GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer

Intervention Type BIOLOGICAL

Placebo

SPGN buffer

Intervention Type BIOLOGICAL

Other Intervention Names

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A/Brisbane/59/07(H1N1)-like delNS1 virus reassortant SPGN buffer

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers, 18-50 years
* Seronegative for H1N1 (Influenza A/Brisbane/59/07 antibody titres \<1:10 detected in haemagglutination inhibition assay)
* Written informed consent to participate in this study

Exclusion Criteria

* Acute febrile illness (\>37.0°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination in 2007/2008 and/or later seasons and/or pandemic influenza vaccination at any time
* 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 incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
* 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