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A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults (FLU003)

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ClinicalTrials.gov Identifier: NCT02335164
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Flinders University
Australian Respiratory and Sleep Medicine Institute
Information provided by (Responsible Party):
Vaxine Pty Ltd

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

Condition or disease Intervention/treatment Phase
Influenza Biological: recombinant influenza hemagglutinin Biological: Advax1 Biological: Advax2 Phase 1

Detailed Description:
This is a study to test new vaccine formulations against pandemic avian influenza ("bird flu"). Bird flu is a potentially deadly disease that is caused by influenza virus from birds. It is not the same as the common seasonal flu for which there is a seasonal vaccine released around March each year. To date, bird flu due to the H5N1 strain of influenza virus has infected over 500 people mainly in Asia resulting in death in more than half the cases. More recently there has been an outbreak of another bird flu virus in China known as H9N7 that is also highly lethal when it infects humans. Vaccination is the single most effective measure to prevent infection from bird flu viruses such as H5N1 or H9N7 should such a pandemic occur. In the event of a major bird flu pandemic outbreak, vaccine supplies are likely to be very limited, as there is not currently sufficient manufacturing capacity to provide enough vaccine quickly for the whole population. Research is needed on how to make the pandemic flu vaccine more effective but also how to stretch vaccine supplies using a strategy called 'antigen-sparing'. This can potentially be achieved by using an important ingredient called an 'adjuvant'. Adjuvants act by stimulating the immune system to make vaccines more effective. This study will test Advax adjuvants which are based on delta inulin in combination with recombinant hemagglutinin from the H5N1 influenza virus serotype.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Controlled, Blinded Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian H5 Influenza Vaccine in Adults
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: HA 45ug
recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Experimental: HA 45ug+Advax1
recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax1
Delta inulin adjuvant formulation 1

Experimental: HA 45ug+Advax2
recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax2
Delta inulin adjuvant formulation 2

Experimental: HA 15ug+Advax1
recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax1
Delta inulin adjuvant formulation 1

Experimental: HA 15ug+Advax2
recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax2
Delta inulin adjuvant formulation 2

Experimental: HA 5ug+Advax1
recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax1
Delta inulin adjuvant formulation 1

Experimental: HA 5ug+Advax2
recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax2
Delta inulin adjuvant formulation 2

Experimental: HA 2.5ug+Advax2
recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Biological: Advax2
Delta inulin adjuvant formulation 2

Experimental: HA 15ug
recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses
Biological: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin




Primary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: 12 months ]
    The frequency of adverse events will be compared between groups


Secondary Outcome Measures :
  1. Hemagglutination inhibition assay [ Time Frame: 1 month post each immunization and 11 months post final immunization ]
    Seroconversion, seroprotection and GMT fold increase will be compared between groups at each time point using hemagglutination inhibition titers


Other Outcome Measures:
  1. Plasmablast response [ Time Frame: 7 and 28 days post each immunization ]
    The size of the plasmablast response will be compared between groups as an experimental endpoint

  2. T-cell response [ Time Frame: 7 and 28 days post each immunization ]
    The size of the memory T cell response will be compared between groups as an experimental endpoint



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335164


Locations
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Australia, South Australia
Flinders University
Adelaide, South Australia, Australia, 5042
Sponsors and Collaborators
Vaxine Pty Ltd
Flinders University
Australian Respiratory and Sleep Medicine Institute
Investigators
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Principal Investigator: Dimitar Sajkov, FRACP, PhD Flinders University

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Responsible Party: Vaxine Pty Ltd
ClinicalTrials.gov Identifier: NCT02335164     History of Changes
Other Study ID Numbers: FLU003
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs