ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000599471

Ethics application status

Approved

Date submitted

14/11/2007

Date registered

21/11/2007

Date last updated

29/06/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Study in healthy Australian adult subjects comparing the standard commercial flu vaccine with an enhanced flu vaccine containing a natural plant-derived immune enhancer

Scientific title

A randomised, controlled Phase 1/2 study in healthy adults of a seasonal influenza vaccine containing an inulin-based adjuvant to evaluate safety and immunogenicity

Secondary ID [1]

FLU001

Universal Trial Number (UTN)

Trial acronym

FLU001

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Seasonal influenza prevention

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparison of intramuscular administration of reduced dose seasonal trivalent inactivated influenza vaccine (15micrograms) containing Advax adjuvant (20mg) versus standard dose intramuscular seasonal trivalent inactivated influenza vaccine (45 micrograms)

Intervention code [1]

Prevention

Comparator / control treatment

Commercial trivalent inactivated seasonal influenza vaccine (45 micrograms) administered by intramuscular injection into deltoid muscle

Control group

Active

Outcomes

Primary outcome [1]

Incidence of adverse events

Timepoint [1]

21 days from immunisation

Primary outcome [2]

Seroconversion and seroprotection against influenza measured according to Therapeutic Goods Administration (TGA) criteria as contained in Harmonisation of Requirements for Influenza Vaccines, Directive 75/318/EEC as amended

Timepoint [2]

21 days post immunisation

Secondary outcome [1]

Kinetics of immunological responses to influenza vaccine (antibody and T cell responses)

Timepoint [1]

T cell responses to influenza haemaggutinin as measured 21 days post-immunisation

Eligibility

Key inclusion criteria

• Non-pregnant
• If child bearing age, using contraception (barrier method, intrauterine device (IUD) or oral contraception)
• Able to provide written informed consent
• Willing and able to comply with the protocol for the duration of the study.

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Known immunodeficiency (including human immunodeficiency virus (HIV)
• diabetes mellitus
• History of vaccine or egg allergy
• Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device (IUD) or mechanical barrier device.
• Pregnant or lactating women.
• Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids).
• Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
• History of intravenous drug abuse or alcohol abuse

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Blinded envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number generator (www.randomization.com)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1 / Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5042

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vaxine Pty Ltd

Address [1]

Flinders Medical Centre
Adelaide SA 5042

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Vaxine Pty Ltd

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Flinders Clinical Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Adelaide SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

A major challenge in influenza vaccines is to find a way to deliver considerably lower doses of influenza vaccine while still being able to elicit a protective immune response. This is because the number of doses of seasonal influenza vaccine able to be generated is limited by production capacity and cost.Extensive animal data indicates addition of a natural plant sugar called Advax  results in enhanced immunity and/or reduced antigen requirements compared to current unadjuvanted human influenza vaccines. This study will test the safety and effectiveness of a low dose flu vaccine containing Advax to the standard full dose commercial flu vaccine.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Nikolai Petrovsky

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Phone

+61 8 82044572

Fax

+61 8 82045987

[email protected]

Contact person for scientific queries

Name

Nikolai Petrovsky

Address

Flinders Medical Centre
Adelaide SA 5042

Country

Australia

Phone

+61 8 82044572

Fax

+61 8 82045987

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with AdvaxTM delta inulin adjuvant.	2016	https://dx.doi.org/10.1016/j.vaccine.2016.05.071

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically