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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000599471

Acronym

FLU001

Enrollment

150

Registered

2007-11-21

Start date

2007-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

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

Outcome results