Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier:
NCT01369862
First received: January 4, 2011
Last updated: January 9, 2014
Last verified: August 2011
  Purpose

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).


Condition Intervention Phase
Influenza, Human
Biological: GHB16L2
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

Resource links provided by NLM:


Further study details as provided by AVIR Green Hills Biotechnology AG:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: From baseline to 30 days after end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Seroconversion rates at day 29 [ Time Frame: At day 29 (end of study) ] [ Designated as safety issue: No ]
    Seroconversion rates for HAI, MNA, IgA and IgG

  • Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding) [ Time Frame: 1 week post immunisation ] [ Designated as safety issue: Yes ]
  • Immune response factor at day 29 [ Time Frame: At day 29 (end of study) ] [ Designated as safety issue: No ]
    Immune response factors for HAI, MNA, IgA and IgG


Estimated Enrollment: 80
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369862

Locations
Austria
Medical University Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
AVIR Green Hills Biotechnology AG
Investigators
Principal Investigator: Michael Wolzt, MD Medical University Vienna
  More Information

No publications provided by AVIR Green Hills Biotechnology AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Muster PhD, CEO/CSO, AVIR Green Hills Biotechnology AG
ClinicalTrials.gov Identifier: NCT01369862     History of Changes
Other Study ID Numbers: GHB-CS08
Study First Received: January 4, 2011
Last Updated: January 9, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by AVIR Green Hills Biotechnology AG:
live attenuated flu vaccines
influenza A (H1N1)
intranasal application
replication-deficient influenza virus

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014