NCT02335164

Brief Summary

Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2015

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

January 4, 2015

Last Update Submit

May 6, 2019

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • The incidence of adverse events

    The frequency of adverse events will be compared between groups

    12 months

Secondary Outcomes (1)

  • Hemagglutination inhibition assay

    1 month post each immunization and 11 months post final immunization

Other Outcomes (2)

  • Plasmablast response

    7 and 28 days post each immunization

  • T-cell response

    7 and 28 days post each immunization

Study Arms (9)

HA 45ug

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutinin

HA 45ug+Advax1

EXPERIMENTAL

recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax1

HA 45ug+Advax2

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax2

HA 15ug+Advax1

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax1

HA 15ug+Advax2

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax2

HA 5ug+Advax1

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax1

HA 5ug+Advax2

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax2

HA 2.5ug+Advax2

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutininBiological: Advax2

HA 15ug

EXPERIMENTAL

recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses

Biological: recombinant influenza hemagglutinin

Interventions

recombinant influenza hemagglutininBIOLOGICAL

recombinant influenza hemagglutinin

HA 15ugHA 15ug+Advax1HA 15ug+Advax2HA 2.5ug+Advax2HA 45ugHA 45ug+Advax1HA 45ug+Advax2HA 5ug+Advax1HA 5ug+Advax2
Advax1BIOLOGICAL

Delta inulin adjuvant formulation 1

HA 15ug+Advax1HA 45ug+Advax1HA 5ug+Advax1
Advax2BIOLOGICAL

Delta inulin adjuvant formulation 2

HA 15ug+Advax2HA 2.5ug+Advax2HA 45ug+Advax2HA 5ug+Advax2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory males or females aged 18 years and over
  • Able to provide written informed consent
  • Willing and able to comply with the protocol for the duration of the study.
  • Not planning to have seasonal influenza vaccine within 2 months from the time of the first trial immunization

You may not qualify if:

  • Pregnant or lactating women.
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method.
  • Receipt of another investigational agent within 28 days preceding initiation of treatment.
  • Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flinders University

Adelaide, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Dimitar Sajkov, FRACP, PhD

    Flinders University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2015

First Posted

January 9, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

May 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

AU(1)