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Influenza APhase 1NCT01677676

Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

A Phase 1 study testing FP-01.1 and FP-01.1-Adjuvant in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1_CS_01. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Influenza A
What is being tested?
FP-01.1 and FP-01.1-Adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteAustralia
Study dates
Jan 2012to Sep 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 55 years inclusive at the time of consent
  • Willing to comply with the applicable contraceptive requirements of the protocol
  • For male subjects, agreement to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner until completion of the Day 57 visit, and refrain from fathering a child at least until completion ofthe Day 57 visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had her womb or both her ovaries removed.
  • OR
  • For female subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the TGA combined with a barrier contraceptive through to completion of the Day 57 visit study and have negative results on a serum or urine pregnancy test done before administration of study medication (women who are postmenopausal [no menses for at least 2 years] are also eligible to participate)
  • Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology, biochemistry or urinalysis) as assessed by the Investigator.
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  • An understanding, ability and willingness to fully comply with study procedures and restrictions
  • Ability to provide written, personally signed and dated informed consent to participate in the study.
  • The subject has a body mass index (BMI) within the range 19.0-32.0 kg/m2 and falls within the weight range of 50.0-100.0 kg.
  • The subject is willing to present a study prepared letter to a General Practitioner (GP) if visiting for any purpose
  • Subject is willing to refrain from consuming alcohol for 24h prior to all visits.

Who cannot join

  • As a result of the medical screening process, the Principal Investigator or Co-Investigator considers the subject unfit for the study.
  • Current, chronic or recurrent disease (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the IMP or could affect clinical or laboratory assessments.
  • Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
  • Subjects with a history of allergies or allergic conditions including anaphylactic reactions, asthmatics, hay fever and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co-Investigator will affect their participation in the study.
  • Subjects receiving medications that affect the immune system including systemic steroids and patients on chronic medications where the dose has not been stable for at least 3 months.
  • Known or suspected intolerance or hypersensitivity to the IMP, or closely related compounds or any of the stated ingredients
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  • History of alcohol or other substance abuse within the last year. A positive screen for alcohol or drugs of abuse.
  • Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
  • A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
  • Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site.
  • Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to or intention to donate blood during the entire study.
  • Use of another investigational medicinal product within 90 days prior to receiving the first dose of IMP or intention to enrol in another clinical study throughout the entire study (up to and including Day 57), including the 6 month follow-up period for those subjects who consent to remain on study for this follow-up.
  • Subject with suspected recent (≤12 months) pre-exposure to the influenza A virus - flu like symptoms associated with ≥ 2 days off normal daily activities
  • Subjects who have received a flu vaccine in the last 12 months or who anticipate receiving it within the duration of the clinical phase of the study (ie up to completion of Day 57) or the period up to the 6 month safety follow-up telephone call, for the subjects who consent to remain on study for this follow-up.
  • Any clinically significant abnormalities, in the opinion of the Principal Investigator or Co-Investigator, on electrocardiograms (ECGs), as assessed against the clinical site's reference range.
  • In addition, for each subject, a completed medical history questionnaire will be taken as part of the consented study procedure.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Q-Pharm Pty Ltd

    Brisbane, Queensland, 4006

Other trials in Australia

About this study

Official title: A Randomised, Double-Blind, Double Observer, Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.

Conditions
Influenza A
Being tested
FP-01.1, FP-01.1-Adjuvant
Keywords
Influenza A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FP-01.1Biological

    Also called Flunisyn

    IM injection

  • FP-01.1-AdjuvantBiological

    Also called Flunisyn + Adjuvant

    IM injection

Study groups in NCT01677676
Study groupRoleWhat they receive
Group 2Active comparatorFP-01.1 (250µg/peptide)
Receives: Biological: FP-01.1
Group 3Active comparatorFP-01.1-Adjuvant (150µg/peptide / 10.8mg)
Receives: Biological: FP-01.1-Adjuvant
Group 4Active comparatorFP-01.1-Adjuvant (250µg/peptide / 18mg)
Receives: Biological: FP-01.1-Adjuvant
Group 1Active comparatorFP-01.1 (150µg/peptide)
Receives: Biological: FP-01.1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and proportion of subjects reporting solicited local reactions and severity of the local reactions

    Measured: Day 1-57

  2. To assess and compare the immunogenicity response between groups

    The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group

    Measured: Day 1-57

  3. Number and proportion of subjects reporting solicited systemic events

    Measured: Day 1-57, optional safety FU day 209

  4. Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)

    Measured: Day 1-57, optional safety follow up at day 209

  5. Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments

    Measured: Day 1-57

  6. Number and proportion of subjects with abnormal vital signs/ECG assessments

    Measured: Day 1-57

Secondary outcomes (1)

  1. Exploratory immunogenicity tests on samples obtained from subjects

    Additional assessment of T cell responses induced by the vaccine including virus strain cross reactivity and intracellular cytokine staining assays.

    Measured: Day 1-57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677676
Sponsor's protocol ID
FP-01.1_CS_02
Status last verified
Jul 2013
First submitted
24 Aug 2012
Last updated
29 Jul 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP-01.1 and FP-01.1-Adjuvant in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and proportion of subjects reporting solicited local reactions and severity of the local reactions (time frame: Day 1-57). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01677676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.

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