As well as EDCTP-managed projects, the EDCTP2 portfolio includes projects that are directly funded and managed by Participating States but fall within the remit of EDCTP2. Submission of such ‘Participating States-initiated activities’ (PSIAs) provides an important mechanism for coordinating activities across European and African partners, avoiding duplication of efforts and helping to identify neglected priorities and evidence gaps.

An in-depth analysis in 2019 found that 400 PSIAs have been submitted to 2014–2020 work plans, 280 from European countries and 120 from sub-Saharan African countries. Collectively, these amount to a financial commitment of €1.06 billion.

Projects have also examined implementation issues, including innovative methods to improve retention in HIV care, as well as a widely used smartphone app on HIV drug interactions to guide clinical decision-making. Evidence on long-lasting insecticidal bed nets impregnated with PBO (piperonyl butoxide) led WHO to revise its guidelines and endorse use of pyrethroid–PBO nets.

The interim analysis of completed projects has also revealed that PSIAs map closely to EDCTP’s priority research questions in each disease area. Where priority topics are not covered by EDCTP projects or PSIAs, this provides insight into remaining areas where evidence is needed, to guide future funding activities. 

As with EDCTP-managed projects, PSIAs are highly collaborative. Notably, one-fifth of PSIA funding has been committed to international product development partnerships. Several of these partnerships are leading or involved in major EDCTP2 trials, emphasising important complementarity between the two funding streams. PSIAs have also provided a mechanism to further advance successful research carried out in the first EDCTP programme.

PSIAs have made many important contributions to the clinical evaluation of new interventions, including those targeted at vulnerable populations such as pregnant women, young children and people with co-morbidities. Examples include work on Ebola vaccines, clinical trials on antiretroviral drugs, and novel diagnostics for TB. 

Of the 184 completed projects to date, PSIAs are well-balanced across disease areas, type of intervention, and stage of clinical evaluation. They include at least 117 clinical studies, as well as projects focused on capacity building and strengthening of ethics oversight and regulatory infrastructure for clinical research. 

The Research Council of Norway provided funding for the development of an Ebola vaccine (rVSV-ZEBOV) through the GLOBVAC programme. This vaccine is based on a modified virus (vesicular stomatitis virus, VSV) capable of expressing Ebola surface proteins and was selected on the advice of WHO to be tested during the Ebola outbreak in West Africa in 2015–2016. To test the effect of the vaccine, the study was planned as a ring vaccination.

Data from the study were published February 2017 in The Lancet, confirming previous data by demonstrating that the rVSV-ZEBOV vaccine provided significant protection against Ebola disease. No Ebola cases were detected among vaccinated individuals from day 10 after vaccination. Analysis of blood samples from vaccinated individuals showed comparable responses as in trials with the vaccine in other countries.

Announcing the data, WHO stated that this study marked a turning point for outbreak health research and that this could be used as a basis for developing a global research framework for emerging diseases. The study was recognized by the journal Science as one of ten scientific breakthroughs in 2015, and was included in National Geographic’s list of the top 20 scientific discoveries of the decade in 2019. The ring vaccination method, which was demonstrated effectively in this study, has been adopted as a tool to fight new Ebola outbreaks, and has been used to vaccinate over 250,000 individuals as of December 2019 in the Democratic Republic of Congo during the second largest Ebola outbreak of all time.

The vaccine was approved by EU and US regulators in November 2019, providing a new tool to control outbreaks.

The study also marked a turning point for health research during outbreaks, and was key to developing the global research framework for emerging infections, the WHO Blueprint for R&D, as well as the Coalition for Epidemic Preparedness Innovations (CEPI).

Information based on final report for PSIA-2016-907 submitted by Norway to EDCTP 

Key reference

Henao-Restrepo AM et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Lancet. 2017;389(10068):505-518. doi: 10.1016/S0140-6736(16)32621-6.

The UK, through the Joint Global Health Trials (JGHT) scheme of the Medical Research Council, the UK Department for International Development, and the Wellcome Trust, supported the TUMIKIA Project, which aimed to determine the most cost-effective treatment strategy and delivery system to interrupt transmission of soil-transmitted helminths (STH). The focus of STH control efforts is annual school-based deworming. However, mathematical modelling suggested that this strategy is unlikely to interrupt transmission, but interruption of STH transmission might be feasible if treatment were expanded to adults and provided more frequently.

The project team conducted a large cluster-randomised trial in Kwale county on the Kenyan coast to evaluate and compare the effects, equity and cost of three different strategies in reducing the prevalence and intensity of STH infection: annual school-based treatment, annual community-wide treatment, and biannual community-wide treatment.

The trial included 120 randomly assigned communities. The results revealed that community-wide treatment with albendazole was more effective in reducing the prevalence and intensity of hookworm among all ages than school-based treatment, although biannual treatment provided little additional benefit. In addition, the project found comparable coverage and effects of the interventions across important demographic and socioeconomic subgroups.

The trial results are consistent with those from previous research on mathematical models of STH transmission and treatment, and highlight a role for community-wide treatment in reducing the prevalence and intensity of hookworm infection. These findings are highly relevant to ongoing discussions concerning post-2020 WHO goals for STH, as they highlight the potential of including a transmission interruption goal in some settings.

These results are also some of the first data highlighting the remarkable equity of the intervention within targeted communities. They also illustrate the reach and equity of the neglected tropical disease delivery platform and the potential to leverage this platform to deliver other health interventions among the poorest, most marginalised communities, and thus contribute towards universal health coverage.

Building upon what was learned during the study, the TUMIKIA team supported the delivery of the lymphatic filariasis mass drug administration (MDA) county-wide in May 2017 and continues to support the Kwale County Ministry of Health to analyse and use these treatment data.

Information based on final report for PSIA-2015-752 (MR/N00597X/1) submitted by the UK to EDCTP 

Key reference

• Pullan RL et al. Effects, equity, and cost of school-based and community-wide treatment strategies for soil-transmitted helminths in Kenya: a cluster-randomised controlled trial. Lancet. 2019;18(393):2039–2050. doi: 10.1016/S0140-6736(18)32591-1.
• Legge H et al. Implementer and recipient perspectives of community-wide mass drug administration for soil-transmitted helminths in Kwale County, Kenya. PLoS Negl Trop Dis. 2020;14(4):e0008258. doi: 10.1371/journal.pntd.0008258.
• Halliday KE et al. Community-level epidemiology of soil-transmitted helminths in the context of school-based deworming: Baseline results of a cluster randomised trial on the coast of Kenya. PLoS Negl Trop Dis. 2019;13(8):e0007427. doi: 10.1371/journal.pntd.0007427.