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Borja Robert
11 months ago
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- [[STOP2030/Web/Update 2024/02]]
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- # Cambios 2024/02
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- Hay que incorporar mucha información técnica que permita a otros investigadores conocer los detalles del proyecto. La web no es solo para público general.
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- Asuntos a incluir:
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- ## Objetivos generales y objetivos específicos del proyecto.
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- *Overall goal*: Support the achievement of the [[WHO]] 2030 NTD Roadmap for [[STH]] and beyond
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- *Project purpose*: Advance and accelerate an innovative pharmacological tool to support the elimination goals against [[STH]] species, specially those poorly responsive to current treatment regimens
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- *The intervention*: A single tablet, [[Fixed-Dose Combination]] of Ivermectin and [[Albendazole]]
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- *Specific objectives*:
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- Provide a tool to support the achievement of the [[WHO]] Roadmap goals for [[STH]]
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- Submission process of [[FDC]] to EMA & national agencies in [[Ghana]] and Kenya
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- Safety and effectiveness tailored to policy makers for the control of [[STH]], including [[Strongyloides stercolaris]] and integration with other NTDs
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- Acceptability, feasibility and adherence data added to the evidence package to support [[WHO]] guidance
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- Develop a model for sustainable supply and costing
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- Model the impact of different use cases and scenarios
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- Pilot antihelmintic resistance surveillance based on genetic epidemiology
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- ## Basic facts del proyecto
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- En qué call de EDCTP (Global Health EDCTP3) ha salido
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- Project duration (36 months); cuando empieza y cuando acaba (20 junio 2026)
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- Cuáles son los Work Packages y quién los lidera
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- ## Timeline y milestones (cuáles se han cumplido?)
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- __Proposed safety and effectiveness study__
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- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
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- *Secondary objectives*:
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- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy
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- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology
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- *Primary goal*: Safety (incidence of SAEs)
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- *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance
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- *Sample size*: approx. 20k.
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- *Target population*: School based
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- *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas
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- *Countries*: [[Ghana]] and [[Kenya]]
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- __Proposed acceptability and feasibility study__
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- *Primary goal*: Acceptability and feasibility
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- *Secondary goals*: Adherence (3-day regimen), fidelity
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- *Countries*: [[Ghana]] and [[Kenya]]
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- *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities
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- ## Objetivos y logros de los proyectos STOP previos (en background)
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- Qualification at EMA for art. 58
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- Safety of IVM up to 600μg/kg alone and in coformulation with albendazole
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- Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa
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- No stopping rules were reached
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- Safety was adequate
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- Palatability results confirm adecuacy of size, taste and smell
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- Superior efficacy against T. trichiura confirms a comprehensive spectrum against STH
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- Los papers más relevantes que salieran de los previos STOP
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- ## Otros facts
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- FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016)
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- Dosing strategies for Ivermectine are being revisited
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- The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies
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- Acceptability and safety studies are underway
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- The access plan is being developed
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- Integration across programs (these results have implications beyond STH)
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- Progress has been achieved through public-private partnerships but more partners are needed to reach the ultimate goal.
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- ## Investigadores principales de cada uno de los partners
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- TODO Mandar un email y pedirles nombres para saber a quiénes citamos en la web y cómo quieren que los mostremos (Foto? enlace a LinkedIn? a página personal de su institución? crear una pequeña bio de cada uno en la web de stop2030?)
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- ## Abstract del proyecto
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- [[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.
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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.
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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.
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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 #INFO
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-
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-
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@ -0,0 +1,66 @@
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# Cambios 2024/02
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||||
- Hay que incorporar mucha información técnica que permita a otros investigadores conocer los detalles del proyecto. La web no es solo para público general.
|
||||
- Asuntos a incluir:
|
||||
- ## Objetivos generales y objetivos específicos del proyecto.
|
||||
- *Overall goal*: Support the achievement of the [[WHO]] 2030 NTD Roadmap for [[STH]] and beyond
|
||||
- *Project purpose*: Advance and accelerate an innovative pharmacological tool to support the elimination goals against [[STH]] species, specially those poorly responsive to current treatment regimens
|
||||
- *The intervention*: A single tablet, [[Fixed-Dose Combination]] of Ivermectin and [[Albendazole]]
|
||||
- *Specific objectives*:
|
||||
- Provide a tool to support the achievement of the [[WHO]] Roadmap goals for [[STH]]
|
||||
- Submission process of [[FDC]] to EMA & national agencies in [[Ghana]] and Kenya
|
||||
- Safety and effectiveness tailored to policy makers for the control of [[STH]], including [[Strongyloides stercolaris]] and integration with other NTDs
|
||||
- Acceptability, feasibility and adherence data added to the evidence package to support [[WHO]] guidance
|
||||
- Develop a model for sustainable supply and costing
|
||||
- Model the impact of different use cases and scenarios
|
||||
- Pilot antihelmintic resistance surveillance based on genetic epidemiology
|
||||
- ## Basic facts del proyecto
|
||||
- En qué call de EDCTP (Global Health EDCTP3) ha salido
|
||||
- Project duration (36 months); cuando empieza y cuando acaba (20 junio 2026)
|
||||
- Cuáles son los Work Packages y quién los lidera
|
||||
- ## Timeline y milestones (cuáles se han cumplido?)
|
||||
- __Proposed safety and effectiveness study__
|
||||
- *Primary objective*: To evaluate and compare safety of a [[FDC]] against [[Albendazole]] alone via [[MDA]] in two study areas in Kenya and [[Ghana]].
|
||||
- *Secondary objectives*:
|
||||
- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[STH]] (T. trichiura, A. lumbricoides, hookworms) [[by]] microscopy
|
||||
- To evaluate the effectiveness of one round of [[MDA]] with [[FDC]] vs [[Albendazole]] against [[Strongyloides stercolaris]] [[by]] serology
|
||||
- *Primary goal*: Safety (incidence of SAEs)
|
||||
- *Secondary goals*: Effectiveness at 21 days and 1 [[year]]; Genomic resistance
|
||||
- *Sample size*: approx. 20k.
|
||||
- *Target population*: School based
|
||||
- *Epidemiologic conditions of the sites*: T. trichiura ongoing transmission areas
|
||||
- *Countries*: [[Ghana]] and [[Kenya]]
|
||||
- __Proposed acceptability and feasibility study__
|
||||
- *Primary goal*: Acceptability and feasibility
|
||||
- *Secondary goals*: Adherence (3-day regimen), fidelity
|
||||
- *Countries*: [[Ghana]] and [[Kenya]]
|
||||
- *Epidemiologic conditions of the sites*: Ongoing [[STH]] deworming activities
|
||||
- ## Objetivos y logros de los proyectos STOP previos (en background)
|
||||
- Qualification at EMA for art. 58
|
||||
- Safety of IVM up to 600μg/kg alone and in coformulation with albendazole
|
||||
- Demonstrated efficacy agrainst T. trichiura in a pivotal trial in Sub-Saharan Africa
|
||||
- No stopping rules were reached
|
||||
- Safety was adequate
|
||||
- Palatability results confirm adecuacy of size, taste and smell
|
||||
- Superior efficacy against T. trichiura confirms a comprehensive spectrum against STH
|
||||
- Los papers más relevantes que salieran de los previos STOP
|
||||
- ## Otros facts
|
||||
- FDC of ivm/alb has the lowest level of investment risk of all candidates for Combination for STH treatment (STH Drug Combinations Expert Meeting, BMGF, April 2016)
|
||||
- Dosing strategies for Ivermectine are being revisited
|
||||
- The fix-dose coformulation of Albendazole/Ivermectine is due to enter regulatory agencies
|
||||
- Acceptability and safety studies are underway
|
||||
- The access plan is being developed
|
||||
- Integration across programs (these results have implications beyond STH)
|
||||
- Progress has been achieved through public-private partnerships but more partners are needed to reach the ultimate goal.
|
||||
- ## Investigadores principales de cada uno de los partners
|
||||
- TODO Mandar un email y pedirles nombres para saber a quiénes citamos en la web y cómo quieren que los mostremos (Foto? enlace a LinkedIn? a página personal de su institución? crear una pequeña bio de cada uno en la web de stop2030?)
|
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- ## Abstract del proyecto
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||||
- [[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.
|
||||
|
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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.
|
||||
|
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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 #INFO
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-
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-
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-
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