Allison MacKinnon

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  • Proven IHN prevention Allison MacKinnon

    Head Technical Services Aqua NA

  • Todays Agenda

    NAV Technology Video

    Summary

    2 Campbell River, British Columbia October 9, 2012

    Innovation in Aqua

    APEX-IHN and Novartis

  • The Current Situation

    2012 IHN Outbreaks

    British Columbia

    IHN confirmed on two farm sites in Tofino North and one farm in Sechelt

    1.9 million fish eradicated at first affected farm in Tofino

    Financial consequence

    Lost revenue totaling millions

    Eradication, disposal, and clean up costs

    Disruption to future harvest plans

    Industry consequences

    Adds more fuel to environmental debate

    Undermines confidence throughout the value chain

    Campbell River, British Columbia October 9, 2012

    Source: Canadian Food Inspection Agency

  • The Disease

    Infectious hematopoietic necrosis (IHN)

    Caused by a rhabdovirus that targets salmonids

    Likely introduced to Atlantic salmon farms by returning Pacific salmon

    IHN is endemic amongst more-resistant Pacific salmon

    Highly infectious among farmed Atlantic salmon

    Current outbreak shows it is very difficult to model and predict

    Campbell River, British Columbia October 9, 2012

    Source: World Organization for Animal Health. An OIE Collaborating Center, Iowa State University College of Veterinary Medicine.

  • The Disease

    Campbell River, British Columbia October 9, 2012

    Source: IHNV White Paper, 2003. Karreman and Stephen, eds.

    TYPICAL MORTALITY CURVE for IHN in Atlantic salmon

  • The IHN virus spreads quickly

    and without warning

    So whats the best way to

    control a lethal disease?

    Campbell River, British Columbia October 9, 2012

  • Stop it before it starts.

    Campbell River, British Columbia October 9, 2012

  • Innovation in Aqua

    In 2001, Novartis began work on a technology

    that would safely and effectively protect fish

    against IHN.

    The result was a new generation of vaccines

    known as NAV vaccines or plasmid DNA vaccines.

    Campbell River, British Columbia October 9, 2012

  • Innovation in Aqua

    What is a NAV vaccine, exactly?

    Rather than using whole viruses, Nucleic Acid

    Vaccines are constructed using only the relevant

    genetic components of the virus that trigger

    antigen development.

    These components are inserted into a circular

    piece of nucleic acid called a plasmid.

    Campbell River, British Columbia October 9, 2012

  • Innovation in Aqua

    What is a NAV vaccine, exactly?

    The plasmid can be injected directly into the muscle, without causing side effects,

    and carries the information directly to cells around the injection point.

    Campbell River, British Columbia October 9, 2012

  • Innovation in Aqua

    What is a NAV vaccine, exactly?

    The plasmid then instructs cells to produce antigens, which initiate an immune response

    mimicking the natural infection of the virus.

    The following video provides further explanation.

    Campbell River, British Columbia October 9, 2012

    NAV Video: Apex-IHN

    E:/IHN Workshop 2012/Clynav_Technology_1080_WMV_110920.wmvE:/IHN Workshop 2012/Clynav_Technology_1080_WMV_110920.wmvE:/IHN Workshop 2012/Clynav_Technology_1080_WMV_110920.wmv

  • Innovation in Aqua

    Benefits of a NAV vaccine

    A more powerful and targeted immune response without the need of an oil adjuvant

    Reduced risk of side effects

    No possibility of inducing the disease

    Greater stability of the vaccine itself

    Campbell River, British Columbia October 9, 2012

  • APEX-IHN and Novartis

    Why APEX-IHN is the best way to

    ensure your farm is protected against IHN.

    Easy to administer

    Safe for humans, the environment, and fish

    Proven highly protective in salmon

    Campbell River, British Columbia October 9, 2012

  • APEX-IHN and Novartis

    Ease of use: dosing and admin

    Dose rate:

    0.05 mL (50 microlitres) injection in the area

    immediately anterior and lateral to the dorsal

    fin in the epaxial muscle

    Composition: Plasmid in saline solution

    Adjuvant: None

    Packaging: Ready-to-use flexible intravenous bag

    Pack size: 250 mL (5000 doses)

    Application:

    Standard injection guns

    0.5 mm X 3 mm stainless needles

    Campbell River, British Columbia October 9, 2012

  • APEX-IHN and Novartis

    Safety assessment

    Human safety

    Self-injection by operator no synthetic adjuvant hence very low risk

    of inflammatory complications

    Dosage Fish vaccine dose relatively low (10 g) as compared to the human

    dose in clinical trials (100 300+ g) where no adverse effects were reported

    Declared safe for humans by Health Canada; poses no risk in food

    Environmental safety

    Plasmids are not organisms and are not self-replicating

    Plasmids are non-infectious

    Expression of the antigen already occurs in the natural environment

    Vaccinated fish do not shed vaccine

    Campbell River, British Columbia October 9, 2012

  • APEX-IHN and Novartis

    Safety assessment (cont)

    Animal safety

    Average mortality in Atlantic Salmon for three batches 1.5 % less than 6 %

    as per requirements

    No significant histopathological observations at the injection site (2x dose)

    No lethargy, darkening, normal return to feed

    Campbell River, British Columbia October 9, 2012

    Source: IVVDC 2006, N.C. Simard. Data on file.

  • Proven efficacy

    In an in-vivo vaccination challenge performed under controlled conditions, APEX-IHN

    proved to be well tolerated and highly effective at protecting Atlantic salmon against IHN.

    APEX-IHN and Novartis

    Campbell River, British Columbia October 9, 2012

    Challenge study

    4 months post vaccination

    Percentage mortality

    of treatment groups

  • Field Performance

    More than 60 million vaccinated since 2005

    No reported adverse events of lack of efficacy claims since APEX-IHN was licensed in 2005

    No reported side effects or downgrades at harvest for the life of the product

    No reported cases of IHN in vaccinated fish

    Campbell River, British Columbia October 9, 2012

  • Summary

    IHN virus continues to be a threat to the industry in BC

    Increased surveillance of wild populations of Pacific salmon species

    Better understanding of the risk factors associated with clinical disease

    Increased research on the dynamics of shed / spread from wild populations

    Proven Protection for plasmid DNA vaccine

    No known treatment for IHN

    Prevention needs to be part of Health Management Plan

    Campbell River, British Columbia October 9, 2012

  • Thank you!

    Campbell River, British Columbia October 9, 2012

    NAAQ2012-001