Project Workplan
The structure of the anticipated project containing seven work packages (WP00 to WP06) is shown in Figure 2.
Figure 2: NOVADUCK project’s structure
WP1 – Preparatory Phase
WP manager: CVI (Vilmos Palfi)
It is essential for such multi-partners project to be able to compare the data generated in different entities. A preparatory phase is definitively needed to share the standard operating procedures (SOPs) and expertise, and verify that the different laboratories obtain comparable results on a set of reference material.
Most of the studies performed with avian influenza are performed in chickens. Ducks are much more difficult to keep and handle in animal facilities than chickens. It is therefore absolutely necessary for all partners involved in duck studies to share knowledge and expertise in handling ducks.
The objective of this work package is to define the common procedures and methodologies to be used by all partners to ensure that all data generated in the project framework can be compared in a harmonised manner
Start month: M1
End month: M5
WP2 - Generation and production of optimised viral vectored vaccines for ducks
WP manager: MERIAL (Michel Bublot)
Several live vector-based vaccines have been developed for different species and diseases. In general, such vectors induced a broader immune response, including humoral and cellular, than the classical inactivated vaccines, due to the de novo intra-cellular expression of immunogenic proteins.
The most immunogenic gene of influenza is the one coding for the haemagglutinin (HA). The choice of the most relevant HA gene is essential for optimal protection. The neuraminidase (NA) gene may potentially increase the immunogenicity of HA-based recombinant vaccine. Another important parameter for immunogenicity is whether or not the HA is presented in a virus-like particle (VLP) structure.
A way to generate VLPs containing the influenza immunogenic proteins (HA ± NA) at its surface is to co-express a retrovirus capsid (gag) gene. This promising strategy, developed recently by EPIXIS, has been found to increase significantly the immunogenicity of a model antigen using DNA vector.
The objectives of this work package are to select the optimal gene insert and to generate and produce viral recombinant vaccine candidates based on three types of viral vector.
Start month: M1
End month: M30
WP3 - Development of Immunological tools
WP manager: VAR (Thierry vandenBerg)
Although many immunological tools exist to study the immune responses in chickens, relatively spare tools are available for ducks. The objective of this work package is to generate data and tools for the evaluation of the immune response induced by vaccination. The whole immune response will be studied including humoral, cell-mediated and mucosal immunity. DIVA tests able to detect infection in vaccinated flocks will be also developed.
Start month: M1
End month: M24
WP4 - Safety and pre-screening of vaccine candidates
WP manager: VMRI (Nick Dren)
The development of new vaccines requires the demonstration of safety, efficacy and manufacturing process consistency. The safety of different candidate vaccines will have to be established before performing a vaccination-challenge study.
The objective of this work package is to compare vaccine candidates’ immunogenicity and safety in order to select the best one.
The immunogenicity studies will evaluate the ability of vaccine candidates to induce an immune response into the target species: ducks. There are two different species of domestic ducks: the Pekin or common duck (Anas platyrynchos) and the Muscovy duck or drake (Cairina moschata). In addition, the mule ducks are the sterile progeny from a cross of common duck females (Anas platyrynchos) that are inseminated by semen from Muscovy drakes (Cairina moschata).The humoral, cellular and mucosal vaccine-induced immune responses will be studied with the tools developed in WP3.
Start month: M4
End month: M36
WP5 - Protection studies (vaccination challenge) and drift
WP manager: AFSSA (Véronique Jestin)
Ultimately, the selected vaccine candidates will have to be evaluated for efficacy in a vaccination-challenge model in the target species: ducks. The first task will be the development of a reproducible challenge model in ducks. Ducks are relatively resistant to AI and the outcome of infection is highly dependent on the HPAI H5N1 strain, the age at infection, and other factors such as the dose and administration routes of challenge and the type of ducks. It will be therefore essential for the NOVADUCK project to define the optimal parameters allowing a severe and reproducible challenge in order to be able to distinguish the vaccine candidates on their efficacy potential. One of the most important efficacy criteria will be to evaluate the ability of the vaccine candidates to decrease the shedding after challenge.
This WP is focused on the assessment of the protection afforded in ducks by the best recombinant vaccine candidate after an experimental challenge, taking clinical signs and shedding of the challenge virus as criteria. It also aims at demonstrating the DIVA characteristics of the vaccine using the suitable companion test developed in this project. In addition, the effect of vaccination on genetic and antigenic drift of the challenge virus will be determined.
Start month: M10
End month: M36
WP6 - Innovation activities and societal aspects
WP manager: MERIAL (Michel Bublot)
This WP will contribute to establish guidelines for developing and assessing safety and efficiency of recombinant AI vaccines, and will ensure that all the work planned in the project is done with respect to all relevant national and ethical rules and more specifically without overusing animals.
Another objective is to grant protection of the inventions and to disseminate the results to scientific, veterinarian and citizen communities.
Start month: M1
End month: M36
