Plasmodium vivax is the most widespread human malaria with 2.5 billion people living at risk in South America, Oceania and Asia. The revised Malaria Vaccine Technology Roadmap to 2030 recognises the severity of P. vivax malaria, calling for a vaccine intervention to achieve 75% efficacy over two years, now equally weighted with P. falciparum. However, if this ambition is to be realised, new and innovative approaches are urgently required to accelerate next-generation vaccine research and development, whilst the few known candidate antigens need to undergo early-phase clinical assessment. Here, we build on exciting breakthroughs in P. vivax vaccine research, recently pioneered in Europe, including new transgenic parasite technologies for functional assay development and production of a parasite clone that is safe for use in controlled human malaria infection (CHMI) clinical models. 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. We will diversify the portfolio of new antigens ready for clinical testing by reverse vaccinology and diversify their delivery with new platforms and adjuvants developed using 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.

Plasmodium vivax is considered the most difficult species of human malaria parasite to eliminate because of the inability of conventional diagnostics to detect individuals who carry dormant liver forms and sustain malaria transmission. The consortium has developed the first diagnostic test that addresses this problem. PvSeroRDT aims to develop a point-of-care (POC) rapid diagnostic test (RDT) to transfer the consortium’s validated lab-based test to the field to support implementation of the P. vivax Serological Test and Treatment (PvSeroTAT) malaria control strategy. The PvSeroRDT specific objectives are: 1) Develop a POC RDT using lateral flow technology to measure antibodies to four P. vivax proteins that are biomarkers for the dormant liver-stage of P. vivax. 2) Establish Africa-based manufacturing capacity at DIATROPIX (Senegal) following RDT development at Abingdon Health, a UK-based SME specialising in lateral flow assays. 3) Validate RDT performance with bio-banked samples, followed by field-based clinical validation on freshly collected samples in Ethiopia and Madagascar. 4) Develop a clear regulatory strategy to streamline market authorization and access to this first-in-class P. vivax serological testing. PvSeroRDT addresses all expected outcomes and impacts of this call topic and work program, respectively. Specifically, it will contribute a robust POC diagnostic to the pipeline in sub-Saharan Africa (SSA) and enable the implementation of the AU-EU Innovation Agenda for public health. The project is designed to address the WHO’s preferred profile for P. vivax diagnosis, to translate an SME prototype to Africa-based industrial design, and to test clinical performance in several SSA sites, thus enhancing international cooperation in SSA and improving training opportunities in SSA. Ultimately, PvSeroRDT will facilitate implementation of PvSeroTAT – a new intervention for malaria elimination.

Cutaneous leishmaniasis (CL) is a neglected tropical disease affecting more than one million people globally each year. In Ethiopia alone more than 40,000 people are thought to be affected annually. Infection results in stigmatising, visible, chronic, scarring skin lesions which cause permanent morbidity and significantly affect mental health, household financial stability and life chances. There is a major need for new therapeutics for CL. The current first line therapy is intramuscular sodium stibogluconate. Treatment is often ineffective, painful, and associated with adverse effects. The complexities of administration mean treatment is restricted to a small number of centralised facilities. As a result the majority of patients receive no treatment. There are a number of promising alternative and novel therapeutics for cutaneous leishmaniasis which may be more effective, more tolerable and more suitable for widespread scale up. However the evidence for these therapies is lacking and this vacuum means that policy cannot be easily changed. Our consortium of leading European and African research institutions proposes a step-change in the evidence base for CL. We will use a multi-arm, multi-stage randomised trial – MAMS4CL - to simultaneously evaluate multiple novel therapeutic interventions. This approach will reduce the time required to identify optimal treatment strategies for CL and transform the therapeutic landscape. We will identify and test five candidate interventions and assess their safety, efficacy, cost-effectiveness, and acceptability. The interventions have been selected as they offer: more tolerable administration, shorter treatment duration or home-based therapy. We will embed within MAMS4CL detailed pharmacokinetic, health economic and social science studies to provide a comprehensive analysis to inform regulators, policy makers and programmes.

The 21st century witnesses increased incidence of epidemics (Zika, dengue, Ebola, SARS), with as latest highlight the recent COVID-19. Following the outbreak of several infectious diseases during the last few decade, the need for generating real-time pathogen genomic data for public health action has become more important than ever. In the African context, infrastructure, human resource capability, data analysis, including bioinformatics, lack of linkage between clinical, epidemiological, and pathogen genomic data as well the interaction between clinicians, researchers and decision makers are some of the major challenges. The aim of the EpiGen project is to build a capacity for integrated pathogen genomic surveillance for informed public health decision process. The overarching specific objectives include strengthening collection and analysis of clinical and epidemiological data, enhancing the capacity and capability for pathogen genomic sequencing, including strengthening the laboratory infrastructure, human work force, pathogen genomic data analysis, and the integration of metadata with genomic data, developing and implementing innovative digital diagnostic platforms, creating semi-real time mobile phone applications for policy decisions, and promoting communities of practice and knowledge exchange through fostering African collaboration and networking in the domain of pathogen genomic surveillance for infectious diseases. EpiGen project’s multi-disciplinary consortium is drawn from several institutions from Ethiopia engaged in National Public Health Programs, and EU partners (The Netherlands, Spain and Germany). Overall, the model approach proposed by EpiGen will enhance Ethiopia’s national effort in mitigating the threat of infectious diseases. The implementation of a national genomic-informed surveillance for infectious diseases will play significant public health role towards contributing to disease prevention and control programmes in Ethiopia and beyond.

P. vivax is considered the most difficult human malaria to eliminate because of the inability of conventional diagnostics to detect individuals with latent liver forms. These individuals account for 80% of all infections and can readily infect mosquitoes. Currently countries can test knowing this has little impact or and the treat everyone which exposes individuals to drugs with potentially dangerous side effects. Parasite specific antibody responses have been shown to correlate with the likelihood of hypnozoite carriage and can be used to identify individuals who should be treated. Aim is to implement a Cluster-Randomised Trial in Ethiopia and Madagascar to demonstrate the effectiveness of a new anti-malaria intervention based on Plasmodium vivax serological testing and treatment (PvSTATEM) with primaquine to prevent the relapse infections responsible for maintaining P. vivax transmission. Simultaneously, we will assess social and health system acceptability of such an approach as well as refine new mobile technologies which interface with point-of-care diagnostic tests and guide treatment decisions. We aim to reduce malaria burden at both the individual and population level in two countries which experience the highest levels of P.vivax in Africa. We expect to have a significant effect in reducing morbidity and improving health. We will ensure community engagement and assess the adoption of new technologies that align with those existing in the health system. The proposal is built on equal partnership and shared capacity to address a substantial public health burden.