NCT03745274

Brief Summary

This study evaluates safety, tolerability and immunogenicity of two doses of GHB04L1, a liquid formulation of the replication- deficient influenza A/Vietnam/1203/04(H5N1)-like ∆NS1 virus in healthy adults. Subjects are randomised at a ratio of 2:1 for GHB04L1 (6.8 log10 or 7.5 log10 TCID50/dose/volunteer) or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

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

December 19, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2009

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 15, 2018

Last Update Submit

November 18, 2018

Conditions

Influenza, Avian

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    Occurrence of local and systemic adverse events overall and within 7 days after each study medication administration

    8 weeks

Secondary Outcomes (7)

  • Viral shedding

    3 days

  • Local immune response

    8 weeks

  • Local cytokines response

    3 days

  • Systemic influenza A virus-specific antibody response

    8 weeks

  • Systemic influenza A virus-specific T-cell response

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

GHB04L1

EXPERIMENTAL

GHB04L1 is administered as intranasal aerosol at a dose of 6.8 log10 or 7.5 log10 TCID50/dose/subject on day 1 and on day 29.

Biological: GHB04L1

Placebo

PLACEBO COMPARATOR

Placebo (buffer) is administered as intranasal aerosol on day 1 and on day 29.

Other: Placebo

Interventions

GHB04L1BIOLOGICAL

Solution

GHB04L1
PlaceboOTHER

Buffer solution

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female healthy volunteers, 18-50 years of age
  • Seronegative for H5N1 (with antibody titres \<1:10 detected in HAI assay)
  • Seronegative for H1N1 (with antibody titres ≤1:20 detected in HAI assay)
  • Written informed consent to participate in this study

You may not qualify if:

  • Acute febrile illness (\>37.0°C)
  • Positive influenza immunoassay at baseline
  • Signs of acute or chronic upper or lower respiratory tract illnesses (sneezing, cough, tonsillitis, otitis, etc.)
  • History of severe atopy
  • Influenza vaccination 2006/2007 and/or later
  • Known increased tendency of nose bleeding
  • Volunteers with clinically relevant abnormal paranasal anatomy
  • Volunteers with clinically relevant abnormal laboratory values Females with positive urine pregnancy test prior to vaccination
  • 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 had undergone rhino or sinus surgery or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
  • Volunteers who had received antiviral drugs, treatment with immunoglobulins or blood transfusions or an investigational drug within four weeks prior to study medication application
  • Volunteers who had received anti-inflammatory drugs 2 days prior to study medication application
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Influenza, Russian Academy of Medical Sciences

Saint Petersburg, 197376, Russia

Location

Related Publications (1)

  • Nicolodi C, Groiss F, Kiselev O, Wolschek M, Seipelt J, Muster T. Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1. Vaccine. 2019 Jun 19;37(28):3722-3729. doi: 10.1016/j.vaccine.2019.05.013. Epub 2019 May 30.

    PMID: 31155415DERIVED

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Officials

  • Oleg Kiselev, Prof

    Research Institute of Influenza, Russian Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

December 19, 2008

Primary Completion

May 27, 2009

Study Completion

May 27, 2009

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)