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

May 6, 2019 updated by: Vaxine Pty Ltd

A Randomised, Controlled, Blinded Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian H5 Influenza Vaccine in Adults

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: 12 months
The frequency of adverse events will be compared between groups
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 month post each immunization and 11 months post final immunization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
7 and 28 days post each immunization
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
7 and 28 days post each immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vaxine Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Australian Respiratory and Sleep Medicine Institute
Flinders University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dimitar Sajkov, FRACP, PhD, Flinders University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Flu003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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