(HORIZON-JU-GH-EDCTP3-2023-01-02) - FUNDING TO SUCCESSFULLY FINALISE EDCTP2-FUNDED CLINICAL TRIALS THAT WERE NEGATIVELY IMPACTED BY THE COVID-19 PANDEMIC
Call: HORIZON-JU-GH-EDCTP3-2023-01 EU
Topic description
ExpectedOutcome:
Project results are expected to contribute to the following outcomes:
- Clinical trials of medical technologies that were funded by EDCTP2 and whose activities were disrupted during the COVID-19 pandemic, can be concluded;
- Information about medical technologies can be used by health care professionals and health care systems.
The following clinical trials – identified by their clinical trial registration numbers - are addressed by this topic:
| ISRCTN[1] 61526229 PACTR[2]202010540737215 | Assessing the safety and tolerability of artemether-lumefantrine+atovaquone-proguanil tri-therapy for malaria treatment in adults and adolescents in Gabon |
| ISRCTN 14750348 PACTR 202201797112873 | A multicentre phase III trial to evaluate the safety, tolerability, and efficacy of a combination of three antimalaria drugs (artemether-lumefantrine+atovaquone-proguanil) versus two malaria drugs (artemether-lumefantrine) +placebo in African children aged 6-59months with an uncomplicated malaria infection |
| PACTR 202011812241529 | Efficacy and safety of pyronaridine-artesunate (Pyramax) for the treatment of falciparum malaria in African pregnant women |
| NCT[3] 03876262 PACTR 202004639229710 | Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis |
| NCT 04311671 PACTR 202003567524647 | Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas |
| NL7294 (NTR7503) https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7503 | Integrated skin screening and SDR-PEP administration for leprosy prevention: comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique, and Tanzania (PEP4LEP) |
| PACTR 202011804563392
| A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) |
| NCT 05119426 | Effectiveness of a Typhoid Conjugate Vaccine in DRC (TyVECO) |
| NCT 05047315 | Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV (Stool4TB) |
| NCT 05048472 | East Africa Point of Care Viral Load Study (EAPoC-VL) |
| NCT 05175794 | Triage Test for All Oral DR-TB Regimen (TRiAD Study) |
| NCT 05317247 | Cough Audio Classification as a TB Triage Test (CAGE-TB) |
| NCT 04145258 | Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis (INTENSE-TBM) |
| NCT 04600167 | Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus (PROTID) |
| ISRCTN 77382043 | Metformin treatment for diabetes prevention in Africa |
| NCT 04653948 | Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital (PREPARE) |
| NCT 04732026 | Serocorrelate of protection against GBS |
| NCT 04596878 | Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV |
| PACTR202208844472053 | Increasing the uptake of intermittent preventive treatment using sulfadoxine-pyrimethamine through seasonal malaria chemoprevention channel delivery |
| NCT05441410
| Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (SPICY) |
| NCT04601714 | Baseline Cohort Malaria Morbidity Study (BLOOMy) |
| PACTR201909810587438 | Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial |
This funding will ensure that essential clinical trials working to deliver answers of immediate public health relevance in SSA can be concluded. Focussing funding to projects previously supported under the EDCTP2 programme is justified by the advanced stage ongoing studies have reached. It is also justified by ethical issues, such as fully validating the willingness of trial participants to take part in the clinical investigations.
The proposals need to address all of the following:
- Demonstrate the work performed so far, such as number of recruited trial participants, follow-up status as well as analyses to be performed;
- Explain the impact of COVID-19-related delays and disruption in relation to the trial timing (start, recruitment, follow-up period);
- Clearly explain the additional work to be carried out, with a comprehensive plan and budget to conclude the planned studies in a tight timeframe;
- Proposals should present a sound assessment of the feasibility of the planned clinical investigations. Realistic plans for recruiting and following up trial subjects must be presented and corroborated by demonstrated success from previous studies and/or the current study;
- Whilst it is acknowledged that the projects build on previous studies, the proposals should briefly recall the justification of the choice of populations to be enrolled into the trials and explain how they relate to the larger population;
It should also be explained how the full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) is considered.
[2]Pan-African clinical trials registry https://pactr.samrc.ac.za/
[3]US National Library of Medicine clinical trial registry https://clinicaltrials.gov/
Expected Impact: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