Roadmap for the development of candidate vaccines for influenza

Vaccine

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Vaccine

Research Question

Develop vaccines with DIVA tests that can be rapidly modified and suitable for mass – administration such as spray, feed or
water or in ovo application
Mucosal vs systemic protection vaccine
Vaccine protection whole year or specific period of time or season
Develop potent vaccines for less immunogenic influenza subtypes (e.g. H9, H7 )
Development of protective vaccines to prevent outbreaks of influenza in poultry, horses and swine

Develop and transfer a process to select and update antigenic epitopes in vaccines based on regional circulating influenza viruses
Develop and validate DIVA tests for specific vaccine technologies
Develop and validate multi – species vaccine platforms that are broadly cross-protective: a universal flu vaccine
Detection systems for vaccine failure
Understanding the role of vaccines in driving escape mutations, and how to prevent them
How to evaluate levels of residual virus in vaccinated animals (Vaccination may not result in sterile immunity)?
Quick development and scale-up of vaccines
Correlates of protection: what are the minimum levels of HA antigen-specific antibodies (Hi, ELISA/or VN) of each of the different formulations of unconventional vaccines e.g. (vectored/subunit) that could induce complete protection from clinical diseases as well as hidden impacts such as reduction in egg
production or compromised resistance from other respiratory infections?
How to evaluate levels of residual virus in vaccinated animals (i.e. is lack of sterilizing immunity is a concern)
Develop appropriate vaccine protocols (How many doses of each vaccine H5, H7 or H9 or H6?Single or multivalent vaccine?)
Is there a practical way to vaccine wild birds
Vaccination should be acceptable for international trade
What is the underlying driver for increased breadth of cross protection?

Testing of nucleic acid-based, vectored, inactivated or subunit vaccine candidates
Assessment of novel vaccines according to their ability to prevent infection and transmission for prolonged periods post-immunization
Vaccine performance under field conditions/studies that validate
laboratory models of vaccination by comparison to field conditions
Novel antigen / vaccine designs in industry
Vaccine platforms that express different multiple antigens(multivalence constructs)
Ability to compare recently developed vaccine constructs head-to-head in sufficiently sized studies to quickly reach conclusions
on usefulness of novel concepts using established criteria (mRNA vaccines, ORF vectored IAV, bivalent LAIV with elastase
dependence strains, computationally, optimized HA antigens in various vectors, chimeric bat NS1-truncated, MLVs, etc.)
Develop alternative to eggs culture for vaccine production – i.e. development of tissue culture system
Research on the various combinations included in the definition of “heterologous prime/boost”

Critical to develop an “adequate surveillance program” that can be implemented with any vaccination strategy to meet trade requirements (IABS meeting 2022) (see disease control roadmap)
Design vaccination strategies that fit species, age, production type and maternal antibody status including priming and boosting with various technologies to optimize protection and duration of immunity (see disease control roadmap)
Develop serological or other in vitro correlates / tests for assessing vaccine protection
Development of nucleic acid-based, vectored, inactivated or subunit vaccines
Diagnostic kits for DIVA compatible vaccines – need to get industrial partners involved
Quick development of vaccine (also not DIVA) to respond rapidly to disease outbreak management during emergency (pandemic/epidemic emergency)
Correlates/tests for vaccine protection in avian species and swine
Knowledge on vaccine effectiveness in different ages

Many DIVA compatible vaccines developed without associated diagnostic kits.
More Difficult DIVA when more than one AIV coinfecting viruses and multiple subtypes of vaccines are used such as H5, H7 and
H9.
The minimum requirement of HI titers in field vaccinated birds, there is a description in OIE terrestrial manual 2012 chapter 3.3.4, C requirements for vaccine 2.3.2. It says, 1/32 to protect from mortality or greater than 1/128 to provide reduction in challenge virus replication and shedding