Summary
Soil-Transmitted Helminths (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in Mass Drug Administration (MDA) campaigns. Renewed targets from WHO for 2030 include elimination of STH morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by WHO for controlling NTDs to attain the Sustainable Development Goals.
The current proposal aims at accelerating the implementation of an innovative health technology, a fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, Kenya and Mozambique with the guidance of EMA and sponsored by EDCTP (STOP projects) with a Phase II trial completed and a Phase III currently recruiting.
This project, STOP2030, seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in Ghana and Kenya, modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and WHO guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the FDC for STH control and elimination.
The Consortium assembled to execute the STOP2030 proposal combines expertise in complementary fields from program assessment and implementation through Ministries of Health in sub-Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained WHO prequalification for generic ivermectin.
The current proposal aims at accelerating the implementation of an innovative health technology, a fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, Kenya and Mozambique with the guidance of EMA and sponsored by EDCTP (STOP projects) with a Phase II trial completed and a Phase III currently recruiting.
This project, STOP2030, seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in Ghana and Kenya, modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and WHO guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the FDC for STH control and elimination.
The Consortium assembled to execute the STOP2030 proposal combines expertise in complementary fields from program assessment and implementation through Ministries of Health in sub-Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained WHO prequalification for generic ivermectin.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101103089 |
| Start date: | 01-07-2023 |
| End date: | 30-06-2026 |
| Total budget - Public funding: | 3 553 502,25 Euro - 3 553 502,00 Euro |
Cordis data
Original description
Soil-Transmitted Helminths (STH) remain a significant public health problem with recognized obstacles for control and elimination with the current benzimidazole regimens in Mass Drug Administration (MDA) campaigns. Renewed targets from WHO for 2030 include elimination of STH morbidity in pre-school and school age children (PSAC & SAC), increased country governance and financial support and a strongyloidiasis control program; 2030 has also been targeted by WHO for controlling NTDs to attain the Sustainable Development Goals.The current proposal aims at accelerating the implementation of an innovative health technology, a fixed-dose combination (FDC) tablet of co-formulated albendazole and ivermectin, with adequate safety and significantly superior efficacy against T. trichiura in a registrational randomized clinical trial. This trial is being conducted in Ethiopia, Kenya and Mozambique with the guidance of EMA and sponsored by EDCTP (STOP projects) with a Phase II trial completed and a Phase III currently recruiting.
This project, STOP2030, seeks to complement the results of the safety and efficacy trial with a field-based safety and effectiveness clinical study, acceptability studies in Ghana and Kenya, modelling and cost-effectiveness exercises. The resulting information will be consolidated to build a multidisciplinary package for policy making and WHO guidance with the support of advocacy and communication activities to reach stakeholders and maximize the exploitation and impact of the FDC for STH control and elimination.
The Consortium assembled to execute the STOP2030 proposal combines expertise in complementary fields from program assessment and implementation through Ministries of Health in sub-Saharan African countries, advocacy, state of the art technology, leadership in clinical research and a pharma that has shown commitment for generating access to drugs against NTDs and has recently obtained WHO prequalification for generic ivermectin.
Status
SIGNEDCall topic
HORIZON-JU-GH-EDCTP3-2022-CALL1-01-01Update Date
31-07-2023
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