Research to rapidly evaluate interventions on Ebola outbreaks in sub-Saharan Africa

Topic description

ExpectedOutcome:

This topic aims at supporting activities that are contributing to one or several of the expected impacts for this call. To that end, proposals submitted under this topic should aim at delivering results that are contributing to some of the following expected outcomes:

• An increased portfolio of therapeutics and diagnostic tools are available to researchers to move along the clinical development phases to combat Ebola disease;
• An improved surveillance system to rapidly detect novel Ebola virus outbreaks in Africa;
• A better understanding of the social dynamics within communities affected by Ebola virus outbreaks and a better awareness from these communities when it comes to the implementation of public health measures such as social restrictions and/or medical interventions;

Proposals submitted under this call topic are expected to advance knowledge on Ebola virus disease with the aim of contributing to an efficient patient management and public health response, as well as better epidemic preparedness in Africa. Special focus should be on improving our understanding of the Sudan virus disease, in view of the recent outbreak in East Africa and the lack of available interventions for this viral strain. There are currently no licensed vaccines or therapeutics for the prevention and treatment of Sudan virus disease^[1].

Ebola is a severe disease, with high mortality risk, first identified in 1976 when two simultaneous outbreaks occurred in South Sudan and the Democratic Republic of the Congo. Ebola viruses are primarily transmitted to humans through close contact with blood, secretions, organs, or other bodily fluids of infected humans or animals, and contaminated surfaces and materials. Infected people generally present with fever, fatigue, muscle pain, headache, and sore throat, followed by vomiting, diarrhoea, rash, and/or symptoms of impaired kidney and liver function. The average Ebola case fatality rate is estimated around 50% with rates varying from 25% to 90% in past outbreaks. Ebola outbreaks have most commonly been caused by the Zaire and Sudan Ebola virus.

The scope of the proposals submitted under this call topic should include one or more of the following areas:

• Clinical development of therapeutics. This can include early phase testing of candidates for safety, validation of standardised animal models that adequately recapitulate the clinical hallmarks of human infection and illness to enable acceleration of regulatory pathways for vaccines and therapeutics, or platform trial designs or networks that can be pivoted to outbreaks where they occur. Best practices for the use and deployment of intervention tools, including storage and transport should be considered.
• Clinical development of point-of-care (POC) diagnostics, ensuring rapid evaluation of POC tools based on existing technologies to allow for fast case detection and better surveillance. It should be possible that the developed diagnostic tools can easily be taken up by health care systems and health care centres, also in rural settings.
• Social sciences research to improve risk communication activities, provide responses to social dynamics of Ebola virus outbreaks and increase acceptance of the public health response and medical countermeasures.

Promotion of close communication between clinical experts, patient communities, regulators, health care workers and policy makers is expected to increase the uptake of a developed intervention and improve outbreak response.

Interaction with relevant national public health institutes and regulatory authorities, African Medicines Agency, Africa Centres for Disease Control and Prevention, World Health Organization - Regional Office for Africa and/or other regional and international relevant organisations are expected to adequately address research needs.

Vulnerable populations need to be included in the clinical study population, including children, pregnant women, people with co-infections and comorbidities, older people and people living in hard-to-reach communities (unless excluded for physiologic or metabolic reasons). Collaboration and coordination with existing outbreak response initiatives and ongoing Ebola research actions are highly encouraged to facilitate knowledge exchange, collaboration, synergies, and coordination of response activities. Community engagement should be supported.

Sex and gender aspects should be taken into account. All data should be disaggregated by sex, age, and other relevant variables, such as by measures of socioeconomic status (i.e., considering the socioeconomic gradient).

^[1]https://www.who.int/emergencies/disease-outbreak-news/item/2022-DON410

Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU

Activities funded under the 2023 calls for proposals should contribute to:

• Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;
• Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda^[1] (expected to be adopted in June 2023) in the area of Public Health
• Provide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;
• Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;
• Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;
• Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;
• Strengthen health systems to ensure uptake of effective health technologies and innovations;
• Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.
• Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa.

^[1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf