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SSPC Impact Case Study: Health

SSPC Impact Case Study: Biologics

OptiViVax, Optimising a High Efficacy Vaccine for Plasmodium Vivax Malaria

Project Lead:

Dr Anne Moore and Dr Sonja Vucen, University College Cork

Areas of Impact:

Environmental, Societal, Training

Scientific Domains:

Biologics / Drug Product, Drug formulation, Novel Modalities

Plasmodium vivax is the most widespread human malaria-causing pathogen with 2.5 billion people living at risk in Africa, South America, Oceania, and Asia. Over the next 5 years, OptiViVax, a newly created consortium across academia and industry, will build will build on exciting breakthroughs in malaria research to integrate state-of-the-art advances in parasite immunology, vaccine design, and innovative pre-clinical and clinical studies, to develop next-generation vaccines with increased efficacy against the P. vivax parasite.

Currently, the 2 approved vaccines against malaria are focussed on P. falciparum and do not protect against P. vivax. While there are many similarities between P. falciparum and P. vivax, there are also major differences which affect the spread of vivax and attempts to control it. Vivax malaria is transmitted rapidly from person to person by mosquitoes, and in contrast to P. falciparum, a single infection can result in repeated disease episodes that are initiated by dormant liver stages of the parasite. Remarkably, vivax relapse is thought to account for the majority of new infections (80-90%). Vivax is more widespread than falciparum and recent studies show a significant burden of disease, particularly in young children and pregnant women. The revised Malaria Vaccine Technology Roadmap to 2030 facilitated by the World Health Organisation recognises the severity of P. vivax malaria, calling for a vaccine intervention to achieve 75% efficacy over two years, equally weighted with P. falciparum.

The OptiViVax consortium brings together academics, non-profits and industrial partners, with expertise in vaccine development, manufacturing, and clinical trials. The project will build on the expertise of its partners in P. vivaximmuno-biology, preclinical functional assays, vaccine development, controlled human malaria infection (CHMI) clinical models and improved GMP bio-manufacturing know-how, to further develop next-generation vaccines with improved efficacy. The objectives of OptiViVax will now integrate ambitious multi-disciplinary scientific and clinical approaches around the parasite’s lifecycle and will use our increased knowledge of P. vivax immuno-biology to further develop next-generation vaccines with improved efficacy.

Diversification of the portfolio of new antigens ready for clinical testing by reverse vaccinology will be enhanced, while also broadening their delivery by incorporating new platforms and adjuvants. These advancements will be achieved by  leveraging sustainable and improved GMP bio-manufacturing know-how. In parallel, the efficacy of known leading antigens will be benchmarked for the first time using innovative design of clinical studies and CHMI models making these lead candidate vaccines ready for future field trials. Improved preclinical functional assays, using state-of-the-art transgenic parasite lines, will also allow for mechanisms of antibody-mediated protection to be deciphered. The availability of new functional assays and human challenge models will underpin the future framework for informed decision making by the clinical vaccine community, policy makers, funders and regulators.

Radboud University Medical Center Foundation, The Netherlands, The National Institute of Health and Medical Research (Inserm), France, University College Cork, Ireland, Armauer Hansen Research Institute, Ethiopia, Vaccine Formulation Institute, Switzerland, London School of Hygiene and Tropical Medicine, UK, The University of Cambridge, UK, The University of Oxford, UK.

Industry partner: Novavax AB, Sweden and Vaccine Formulation Institute, Switzerland

The project is supported by funding from the European Union, the United Kingdom government, and Swiss State Secretariat for Education, Research and Innovation (SERI).

Budget: €11,170,737.1
Websites: https://cordis.europa.eu/project/id/101080744

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