EDCTP portfolio: Emerging diseases

The ALERRT consortium will ensure that African countries are better prepared to carry out research during emergency infectious disease outbreaks.

Accelerating research in emergency situations

Africa is at risk of a multitude of emerging and re-emerging infections, including Ebola and other viral haemorrhagic fevers, yellow fever and plague. If not controlled effectively, outbreaks can have a catastrophic human and economic impact – the 2014–16 Ebola epidemic claimed 11,000 lives and cost the three countries affected an estimated US$2.2 B in lost GDP in 2015 alone.

Clinical evaluation of new interventions for emerging infections is particularly challenging as new vaccines, drugs and diagnostics can only be tested during emergency outbreak situations. At these times, public health responses are naturally focused on treatment and prevention of spread, but outbreaks also provide an opportunity when much can be learned that could improve treatment and prevention of future outbreaks. It is therefore vital that research is embedded in these responses.

The challenge

ALERRT is a multidisciplinary consortium building a patient-centered clinical research network to respond to epidemics across sub-Saharan Africa. It aims to reduce the public health and socio-economic impact of disease outbreaks by building a sustainable clinical and laboratory research preparedness and response network.

Since speed of response is critical in emergency situations, capacity for clinical research and response procedures must be established in advance and maintained at an appropriate level of readiness to allow rapid mobilisation when needed. The network will enable high-quality and ethical clinical research studies to be designed and launched rapidly in response to outbreaks.

Its work will span development of laboratory infrastructure and IT platforms to support research, as well as training to ensure rapid initiation of operations. Extensive community engagement will be undertaken to ensure that its activities are accepted and welcomed by local communities.

The project

ALERRT has already been called into action, following a formal request from the Republic of Congo for help with control of an Ebola outbreak in 2018. The consortium provided advice on local surveillance activities and diagnostic tools, and organised training on the rapid and rigorous review of research proposals for emergency situations.

The 2014–16 Ebola epidemic illustrated that the world was poorly prepared to organise and coordinate clinical research during outbreak situations, when vital information could have been obtained on new vaccines and drug treatments. Alongside global initiatives to coordinate research during emergency situations, and together with a complementary EDCTP-funded initiative, PANDORA-ID-NET, ALERRT will ensure that African countries are better prepared to prevent, respond to and minimise the impact of infectious disease outbreaks.

Impact


test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Africa is at risk of a multitude of emerging and re-emerging infections, including Ebola and other viral haemorrhagic fevers, yellow fever and plague. If not controlled effectively, outbreaks can have a catastrophic human and economic impact – the 2014–16 Ebola epidemic claimed 11,000 lives and cost the three countries affected an estimated US$2.2 B in lost GDP in 2015 alone.

Clinical evaluation of new interventions for emerging infections is particularly challenging as new vaccines, drugs and diagnostics can only be tested during emergency outbreak situations. At these times, public health responses are naturally focused on treatment and prevention of spread, but outbreaks also provide an opportunity when much can be learned that could improve treatment and prevention of future outbreaks. It is therefore vital that research is embedded in these responses.

ALERRT is a multidisciplinary consortium building a patient-centered clinical research network to respond to epidemics across sub-Saharan Africa. It aims to reduce the public health and socio-economic impact of disease outbreaks by building a sustainable clinical and laboratory research preparedness and response network.

Since speed of response is critical in emergency situations, capacity for clinical research and response procedures must be established in advance and maintained at an appropriate level of readiness to allow rapid mobilisation when needed. The network will enable high-quality and ethical clinical research studies to be designed and launched rapidly in response to outbreaks.

Its work will span development of laboratory infrastructure and IT platforms to support research, as well as training to ensure rapid initiation of operations. Extensive community engagement will be undertaken to ensure that its activities are accepted and welcomed by local communities.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

ALERRT has already been called into action, following a formal request from the Republic of Congo for help with control of an Ebola outbreak in 2018. The consortium provided advice on local surveillance activities and diagnostic tools, and organised training on the rapid and rigorous review of research proposals for emergency situations.

The 2014–16 Ebola epidemic illustrated that the world was poorly prepared to organise and coordinate clinical research during outbreak situations, when vital information could have been obtained on new vaccines and drug treatments. Alongside global initiatives to coordinate research during emergency situations, and together with a complementary EDCTP-funded initiative, PANDORA-ID-NET, ALERRT will ensure that African countries are better prepared to prevent, respond to and minimise the impact of infectious disease outbreaks.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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