NCT01369862

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 10, 2014

Status Verified

August 1, 2011

Enrollment Period

7 months

First QC Date

January 4, 2011

Last Update Submit

January 9, 2014

Conditions

Influenza, Human

Keywords

live attenuated flu vaccinesinfluenza A (H1N1)intranasal applicationreplication-deficient influenza virus

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events

    From baseline to 30 days after end of study

Secondary Outcomes (3)

  • Seroconversion rates at day 29

    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

    At day 29 (end of study)

Study Arms (2)

SPGNH buffer

PLACEBO COMPARATOR

SPGNH buffer administration by liquid nasal spray

Biological: Placebo

GHB16L2

EXPERIMENTAL

Dose level \~7.0 log10 fTCID50/strain/person

Biological: GHB16L2

Interventions

GHB16L2BIOLOGICAL

A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants

GHB16L2
PlaceboBIOLOGICAL

SPGNH buffer

SPGNH buffer

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 24183981DERIVED

MeSH Terms

Conditions

Influenza, HumanOrthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Michael Wolzt, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2011

First Posted

June 9, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 10, 2014

Record last verified: 2011-08

Locations

AU(1)