Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults (GHB-CS03)

AVIR Green Hills Biotechnology

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Other: Placebo; Biological: GHB04L1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00741806

GHB-CS03

EudraCT 2007-003219-29

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

GHB04L1

Experimental group

Description:

Single dose, dose escalation

Treatment:

Biological: GHB04L1

SPGN buffer

Placebo Comparator group

Treatment:

Other: Placebo