Home Work Product development Large Ruminant Programmes
Animal African Trypanosomiasis (AAT)Contagious Bovine Pleuropneumonia (CBPP)East Coast Fever (ECF)Foot and Mouth Disease (FMD)Lumpy Skin Disease (LSD)Rift Valley Fever (RVF) 

Animal African Trypanosomiasis (AAT)

Past activities & Achievements  

Since the inception of the program in 2011, we have successfully collaborated with a large group of partners to develop a better product for reducing the impact of this major African cattle disease. More than 20 such research partnerships have comprised a global mix of private pharmaceutical companies, universities and public research institutes. These collaborations originally included a search for an effective vaccine. The focus has subsequently changed to the discovery and development of a new class of trypanocides, a pen-side diagnostic test, improved integrated control methods and better quality control for the various drugs sold throughout Africa. A variation of the pen-side diagnostic test is now marketed by a commercial animal health company whilst the trypanocide is close to moving into full development with a private sector partner.

 

Overview and Objectives 

The focus of the AAT program, particularly in regard to the development of a new therapeutic drug, is to find a lead drug candidate and to ‘de-risk’ its development to a point where a commercial partner will take the development and manufacture further, ultimately into the market.

Over the lifetime of the project approximately 12,000 compounds have been triaged and ultimately one group of compounds, which showed early promise in cattle studies, were further refined through a process of lead optimisation to a point where a candidate fulfilling the Target Product Profile (TPP) in terms of dose rate, cost and withdrawal period has been identified. Subject to confirmation of formulation and manufacturing process improvements it looks likely that the chosen compound will go into final development in July 2020 with the objective of achieving the first marketing approvals in 2026.

 

Programme Activities  

Current activities include chemical process optimisation, upscaling of the manufacturing process for the drug substance and chosen formulation, residue determination, in animal dose confirmation and target animal safety, some semi-field efficacy studies, environmental toxicology determination and ongoing toxicology studies on the compound.

 

Contagious Bovine Pleuropneumonia (CBPP)

Past activities & Achievements

There are existing vaccines available in Africa against CBPP, but there is great scope to develop a more effective, accessible system of integrated disease control. Our first work towards this was to test the BEN-1 cattle vaccine, used to eradicate CBPP in China, in an African context. From 2014 to 2017, we coordinated a consortium led by the Harbin Veterinary Research Institute, which originally developed the vaccine in the 1960s. Three batches of BEN-1 vaccine were produced and trialled in Africa, and found to be effective, but no more effective than the existing vaccine. Work is now proceeding to improve the performance and production processes of the existing vaccine. Additionally, data on the use of two modern antibiotics for the treatment of clinical cases of CBPP will be incorporated into an integrated control programme model.

 

Overview and Objectives

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.

 

East Coast Fever (ECF)

Past activities & Achievements

The only immunological intervention that protects cattle against ECF is the ECF-ITM (Infection and treatment method) vaccine (the largest example is the Muguga Cocktail), which is relatively complicated to manufacture and administer, yet highly effective. ECF-ITM involves injecting a preparation of live sporozoites of the Theileria parva parasite at the same time as a long-acting antibiotic. GALVmed supported work to improve the production process – reducing the vaccine production time by three months and cattle usage by 80% – while transferring the technology from the International Livestock Research Institute (ILRI) in Nairobi, where it was originally produced, to larger-scale production at the African Union Centre for Ticks and Tick-borne Diseases (CTTBD) in Malawi. This vaccine is registered in Malawi and is in the process of registration in three other East African countries. Development work has also been conducted to produce 10-dose vials of the ECF-ITM vaccine, which would be preferable for the small-scale livestock keeper rather than the current 40-dose vials. A novel diluent, which will significantly reduce the production, distribution and storage costs of the ECF-ITM vaccine, has been identified and is ready to be field-tested before commercial implementation. Despite the complex process of producing and administering this vaccine, an unprecedented 1.7 million cattle have been vaccinated so far.

 

Overview and Objectives

The current support for the extended use of the Muguga Cocktail version of ECF-ITM is to publish field epidemiological data on T parva strain prevalence and efficacy data from field exposure studies. A small project conducted in collaboration with Sciensano, Brussels, Belgium aims to simplify the formulation and potency release assays of the Muguga Cocktail ECT-ITM.

 

Foot and Mouth Disease (FMD)

Past activities & Achievements

Historically Foot and Mouth Disease has not had a funded programme in GALVmed.

 

Overview and Objectives 

Launched in January 2020, the AgResults Foot and Mouth Disease (FMD) Vaccine Challenge Project is an eight-year, US$15.8 million prize competition, being implemented by GALVmed, that supports the development and uptake of high-quality FMD vaccines, tailored to meet the needs of Eastern Africa, targeting in particular: Burundi, Ethiopia, Kenya, Rwanda, Tanzania and Uganda. The competition is funded by AgResults, a collaboration between BMGF and the Australian, Canadian, UK and US governments.

Through a pay-for-results mechanism, the Project, aims to achieve 3 objectives:

  1. Develop high-quality FMD vaccines, tailored for the needs of Eastern Africa.
  2. Increase vaccine production and regional purchases to create greater market stability and affordability.
  3. Encourage the development of a private sector model for buying and distributing FMD vaccines, to complement public sector efforts.

To achieve this, the Project will utilise a cost-share mechanism that reduces the cost-per-dose for FMD vaccine buyers, enabling public and private sector actors to better combat FMD through more consistent purchases of the new vaccines. This will also increase the market potential for vaccines in the region.

 

Programme Activities 

In 2019 GALVmed was awarded the contract to be Project Manager of the AgResults FMD Vaccine Challenge Project.  The overall objectives are to: a) incentivise manufacturers to develop and register multi-serotype FMD vaccines that are appropriate for use in target Eastern African countries (Burundi, Ethiopia, Kenya, Rwanda, Tanzania and Uganda), and to b) encourage government and private sector buyers to increase the volume of vaccines purchased through the use of a cost-share mechanism, helping them to better combat the disease and creating a larger, more attractive market that can encourage vaccine manufacturers to remain in the region after the completion of the Project.

The Project is being implemented as a two-phased competition:

  1. Development Phase: During this phase, which began in February 2020, animal health companies (Competitors) are working on the development of FMD vaccines tailored to the needs of Eastern Africa.  The Target Product Profile (TPP), set out in the Competition Rules, defines the characteristics which a vaccine must meet including standards related to safety, efficacy and utility in the small-scale livestock producer setting. The Competition requires vaccines to be registered in the Project’s target countries; either through the East African Community Mutual Recognition Procedure (EAC MRP) or individual country registration procedures.  A vaccine which is granted full product registration in at least 2 of the target countries and demonstrates compliance with all the requirements of the TPP, as assessed by the Project’s Judging Panel, will then be approved as eligible for the next phase of the Competition.
  2. Cost-Share Phase: The phase will begin 2-4 years after the start of the Development and is expected to last 4.5 years.  The commencement of this phase will be announced via the Project’s website, press releases and directly to those organizations that have signed up to the Project’s mailing list.  To support the adoption of new high-quality vaccines in the region, AgResults has established a cost-share mechanism which will reduce the cost-per-dose for both public and private sector buyers. Each year, AgResults commits to funding a portion of the purchase price of the vaccine for a specified volume of vaccine doses and will provide funding directly to vaccine manufacturers. The cost-share awards will be available for 4.5 years after the first eligible vaccine is approved. Competitors will only be eligible to access the cost-share awards in countries where their vaccine has been granted full product registration.

 

More details can be found on the AgResults FMD Vaccine Challenge Project webpages.

 

Lumpy Skin Disease (LSD)

Past activities & Achievements

A limited project was undertaken with the OIE Reference Laboratory for LSD at Sciensano, Belgium to determine the comparative merits of different commercially available and prototype LSD vaccines, both live attenuated and killed. It was clear that the duration of immunity was longer for the live attenuated vaccines used in the study.

 

Overview & Objectives

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.

 

Rift Valley Fever (RVF) 

Past activities & Achievements

Together with a commercial partner GALVmed has focused on a cattle vaccine to protect against RVF infection using the strain known as Clone 13. This vaccine strain was known to be effective but did not have a long shelf life. Stability improvements have extended its shelf life beyond 12 months, opening up the possibility of establishing a strategic reserve of the vaccine that can be quickly deployed across Southern Africa to prevent epidemics. Parallel work developing a rapid pen-side diagnostic test to track the disease in the field easily was completed. The technology is being transferred to a partner for manufacturing and distribution. Clone 13 has the potential for use in combination vaccines for other cattle, sheep and goat diseases.

 

Overview and Objectives

The deployment and provision of RVF vaccination is being addressed through policy debate, including regional and supranational stakeholders.

A current project with a commercial partner to develop a combination vaccine of CBPP and LSD offers significant potential value to small-scale livestock keepers as a single administration. The option of concurrent RVF vaccine administration offers enhanced inter-epidemic use of RVF vaccine (where epidemiologically appropriate). The target geographies for the vaccine are East, Central, West and Southern Africa.