Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

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).

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Placebo; Biological: GHB16L2

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna, Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SPGNH buffer; SPGNH buffer administration by liquid nasal spray	Biological: Placebo; SPGNH buffer
Experimental: GHB16L2; Dose level ~7.0 log10 fTCID50/strain/person	Biological: GHB16L2; A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events	From baseline to 30 days after end of study

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AVIR Green Hills Biotechnology AG
• Investigators: Principal Investigator: Michael Wolzt, MD, Medical University Vienna

Publications and helpful links

General Publications

• Mossler C, Groiss F, Wolzt M, Wolschek M, Seipelt J, Muster T. Phase I/II trial of a replication-deficient trivalent influenza virus vaccine lacking NS1. Vaccine. 2013 Dec 16;31(52):6194-200. doi: 10.1016/j.vaccine.2013.10.061. Epub 2013 Oct 30.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: intranasal application; live attenuated flu vaccines; replication-deficient influenza virus; influenza A (H1N1)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: GHB-CS08