Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

Phase 1

Completed

• Conditions: Influenza, Human
• Interventions: Biological: Placebo; Biological: GHB16L2

• Registration Number: NCT01369862
• Lead Sponsor: AVIR Green Hills Biotechnology AG

Brief Summary

The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).

Detailed Description

GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy male and female volunteers, 18-60 years
• Seronegative for one or two of the applied vaccine strains
• Low antibody titres for H1N1v
• Written informed consent to participate in this study
• For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices

Exclusion Criteria

• Acute febrile illness (>37.3°C)
• Signs of acute or chronic upper or lower tract respiratory illnesses
• History of severe atopy
• Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time
• Fever ≥38.0°C in the time period between the pre-screening visit and day 1
• Known increased tendency of nose bleeding
• Volunteers with clinically relevant abnormal paranasal anatomy
• Volunteers with clinically relevant abnormal laboratory values
• In female volunteers of childbearing potential, a positive urine pregnancy test
• 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 4 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPGNH buffer	Placebo	SPGNH buffer administration by liquid nasal spray
GHB16L2	GHB16L2	Dose level \~7.0 log10 fTCID50/strain/person

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	From baseline to 30 days after end of study

Secondary Outcome Measures

Name	Time	Method
Immune response factor at day 29	At day 29 (end of study)	Immune response factors for HAI, MNA, IgA and IgG
Seroconversion rates at day 29	At day 29 (end of study)	Seroconversion rates for HAI, MNA, IgA and IgG
Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)	1 week post immunisation

Trial Locations

Locations (1)

Medical University Vienna, Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria