bl 5 business plan 2008-2013 - world health organizationbusiness plan: business line 5 –...

BL 5 Business Plan 2008-2013

Innovative vector control interventions

Draft Business Plan for JCB

May, 2007

Business plan: Business line 5 – Innovative vector control interventions

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TABLE OF CONTENTS

EXECUTIVE SUMMARY .....................................................................................................2

1. OBJECTIVES ......................................................................................................................4

1.1. OVERALL OBJECTIVE................................................................................................4

1.2. SPECIFIC OBJECTIVES ...............................................................................................4

2. NEEDS AND OPPORTUNITIES ......................................................................................5

2.1. NEEDS............................................................................................................................5

2.2. OPPORTUNITIES..........................................................................................................6

3. COMPARATIVE ADVANTAGE ......................................................................................9

3.1. TDR EXPERIENCE .......................................................................................................9

3.2. SYNERGIES WITH OTHER ORGANIZATIONS......................................................10

4. ACTIVITIES AND END PRODUCTS............................................................................12

4.1. KEY ACTIVITIES........................................................................................................12

4.2. END-PRODUCTS ........................................................................................................13

4.3. INTERIM IMPLEMENTATION MILESTONES........................................................14

5. FUNDING...........................................................................................................................18

5.1. RESOURCE REQUIREMENTS ..................................................................................18

5.2. RATIONALE FOR RESOURCES REQUIRED ..........................................................18

6. RISKS..................................................................................................................................20

ANNEX ...................................................................................................................................21


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EXECUTIVE SUMMARY

Needs and Opportunities

Most neglected tropical diseases are transmitted by insect vectors, and there is a major need for research to develop improved vector control tools and strategies for prevention of these diseases. Genome sequencing of the main vectors of malaria, dengue, and human African trypanosomiasis (HAT) brings the promise of radically improved vector control methods, but their development will require careful coordination and field evaluation of the new approaches. Community-based vector control traps for HAT can effectively reduce the tsetse fly population. However the application of these traps has not been sustainable, partly because of technical constraints such as variations in their attractiveness for different species of tsetse flies. In the case of malaria, there is a need to generate new knowledge on vector biology, ecology and insecticides resistance in order to improve the implementation of existing vector control strategies. Elimination of transmission of Chagas disease was achieved in several countries in South America, but the vector control methods used are not appropriate for Central America where transmission is maintained by peridomestic and sylvatic triatomine vectors.

Overall Objective

To develop and evaluate improved and innovative vector control methods for the prevention of neglected diseases

Specific Objectives

• To promote the development and testing of new methods for improving Human African Trypanosomiasis (HAT) vector mass-trapping systems, and support the generation and exploitation of Glossina genome sequence data

• To advance the development and evaluation of new and improved integrated methods for malaria and dengue vector control

• To progress the development and evaluation of alternative methods for the prevention of re-infestation and the control of Chagas disease vectors

Activities

The activities of the business line will range from funding competitive research grants and supporting investigators to generate new knowledge on vector biology and to develop improved vector control methods; facilitating research activities undertaken by others to generate vector genome data; developing methodologies and criteria for field testing of new methods and approaches, including issues relating to ethical, legal and social implications


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(ELSI) of genetic modification of insect vectors, and supporting capacity building and ensuring active involvement of DEC researchers in the different research activities. The facilitating and coordinating role will build on the current TDR activities in this area, which are highly appreciated by all key partners.

End-Products

• Improved odour baits and odour release system for tsetse traps by 2011

• New and improved large-scale tsetse mass-trapping methods by 2012

• Glossina genome sequence data generated by 2010

• Criteria for biosafety and efficacy evaluation of GM vectors established by 2013

• Improved methods for integrated malaria vector control approaches by 2012

• Improved methods for targeted and integrated dengue vector control by 2012

• Methods for identification of the origin of triatomine re-infestation by 2010

• Improved methods for preventing Chagas disease vector re-infestation by 2012

• New methods for Chagas disease vector control developed and evaluated by 2013

Comparative Advantage

TDR has demonstrated research leadership as indicated by the multiple reviews it has published on vector control and the scientific working group meeting convened in 2002 where it defined the issues and challenges of vector control and recommended new research directions. TDR’s catalytic role in vector research is expressed through examples such as the malaria vectors genetic transformation network and the International Glossina Genomics Initiative (IGGI) consortium. TDR is currently in the process of collaborating with multiple partners in the area of vector research including entities like the Sanger Centre (UK), Genoscope and IRD (France), Riken Genomic Sciences Centre (Japan), Yale University School of Medicine (USA), Liverpool School of Tropical Medicine (UK), the SANBI (South Africa) and the Wellcome Trust. The Gates Foundation and the NIH Foundation have agreed to collaborate with TDR for malaria and dengue. Much of this interest relates to TDR leadership in promoting the debate on, and pragmatic research response to, Ethical, legal and social issues (ELSI) of genetically modified disease vectors in public health through a publication in 2003. This is of critical importance for the potential testing and delivery of innovative genetically modified organisms. Operating under the auspices of WHO greatly facilitates the ability to link research into policy and practice, for example there is already a long-standing collaboration between PAHO and TDR for Chagas. Finally TDR is also renowned for its achievements in capacity building and networking as illustrated by its support for the bioinformatics and functional genomics training centres in Thailand (for Asia) and Mali (for Africa) and its strong engagement of DEC institutions in the ELSI debate.


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1. OBJECTIVES

1.1. OVERALL OBJECTIVE

To develop and evaluate improved and innovative vector control methods for the prevention of neglected diseases

1.2. SPECIFIC OBJECTIVES

1. To promote the development and testing of new methods for improving Human African Trypanosomiasis (HAT) vector mass-trapping system, and support the generation and exploitation of Glossina genome sequence data

2. To advance the development and evaluation of new and improved integrated methods for malaria and dengue vector control

3. To progress the development and evaluation of alternative methods for the prevention of re-infestation and the control of Chagas disease vectors


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2. NEEDS AND OPPORTUNITIES

2.1. NEEDS

Vector-borne infectious diseases are emerging or resurging because of changes in public health policy (such as a shift in emphasis from prevention to emergency response); insecticide and drug resistance; demographic and societal changes; genetic changes in pathogens and limited ability and resources to implement control measures. Insect vectors transmit seven (malaria, dengue, lymphatic filariasis, onchocerciasis, African trypanosomiasis, Chagas disease, and leishmaniasis) of the ten diseases that TDR currently works on. These diseases occur in more than 100 countries, affect nearly half of the world's population, and result in high morbidity and mortality. Together, they are responsible for more than 500 million clinical cases per year (nearly one person in ten). Their total burden is about 56 million Disability Adjusted Life Years (DALYs). Effective prevention strategies can reverse this trend. Thus, there is a significant need for improved and innovative vector control tools and strategies for prevention of these neglected diseases. The specific needs for the diseases of focus in this business plan are described as follows.

The control of African trypanosomiasis has been limited because of reduced vector control efforts and inadequacy of other existing interventions e.g., drugs are not adequate. Several vector control methods (traps, screens, application of insecticides on traps or livestock, sequential aerial application of insecticides, sterile insect technique, and community-based vector control interventions) were developed over the years. They were proven effective in the control of human sleeping sickness through fly population density reduction or elimination. However, their adoption and application as community-based intervention strategies have not been sustainable. The reasons include the difficulties in using the tools and variability in attractiveness of the traps to the different species of tsetse flies. Therefore, effective management and control require additional tools in vector control that TDR can help facilitate by improving existing tools and their implementation strategies through generation and exploitation of knowledge about vector population biology and ecology. In addition, the facilitation of the Glossina genome sequencing and the exploitation of its data would speed up the development of improved control methods and the generation of new knowledge by networks of investigators.

In recent years, the contribution of vector control to the prevention of malaria has been limited due to scant knowledge of vectors and their environment, poor implementation of existing interventions at large scale, spread of insecticide resistance of vectors, and limited human resources. Thus, there is the need to improve the implementation of existing vector control strategies such as insecticide-treated materials, indoor residual spraying of insecticides, environmental management and integrated vector management, through


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generation and careful exploitation of data about vector biology, ecology, and resistance to insecticides and new technologies. This exploitation of the knowledge about the vectors would provide the basis for decision about where, when and how to apply the control strategies. In addition, there is the need to develop new control methods based for example on genetic or biological control approaches.

The continuing spread and increase in incidence of dengue supports conclusions that the current control measures have not been effective or applied correctly. In the absence of a vaccine and efficient treatment, vector control remains a primary approach to dengue control. Therefore, against Aedes aegypti vector of dengue, there is the need to optimize vector sampling methods, and application of insecticides and to develop community-based vector control interventions. In addition, there also is the need to develop new control methods based on genetic or biological control approaches.

Successful vector control for the prevention of Chagas disease was achieved in the Americas based on the application of insecticides to control domestic triatomine populations. However, this approach has been ineffective against the invasion of bugs from peridomestic and sylvatic areas. Therefore, the development of new tools that prevent re-infestations of triatomine populations is a high priority. New control approaches include genetically-engineered bacterial symbionts and biological control agents, for use as part of an integrated vector management program. Another approach that contributed partly to the control of vectors is house improvements designed to reduce bug infestations. However, the high costs of these activities prevents their wide spread implementation.

In addition to the control needs described, there is the need to foster insect vector genome sequencing and exploitation of genome data with the involvement of Disease Endemic Countries' (DECs) investigators, institutions, and public private partnerships. This will provide opportunities for developing tools and generating knowledge for designing new vector control approaches. Moreover, there is the need to build partnership and strengthen the capabilities of DECs' researchers and health workers to undertake vector research and control through enhanced transfer of new technologies to DECs.

2.2. OPPORTUNITIES

Opportunities for the control of HAT vectors are promoted by the following:

a) The low reproductive rate of tsetse flies that provide a chance to reduce populations effectively

b) The African region proposed strategy (AFR/RC55/R3 of 25 August 2005) for the control of Human African Trypanosomiasis aiming at elimination of the disease as a public health problem by 2015. One of the proposed approaches is through


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intensified use of traps for vector control in endemic and epidemic regions

c) The International Glossina Genomics Initiative (IGGI) is a consortium created with TDR support in 2004. It aims at facilitating the sequencing of the Glossina genome and the exploitation of its data in collaboration with DECs. In addition, it aims at mobilizing the African trypanosomiasis research and control communities around activities for disease prevention

d) The availability of extensive GIS-based tsetse fly distribution prediction maps for risk mapping analysis

e) New prospect for external funding through the Gates Foundation for example

Opportunities for research on malaria and dengue vector control are enhanced by:

a) The existence of growing research communities investigating disease control with the state-of-the art technology

b) A high commitment from DECs to address malaria and dengue vector control

c) The availability of vector genome data for Anopheles gambiae and Aedes aegypti

d) For malaria and dengue vector control, genetic and chemical strategies aiming at the interruption of parasite/pathogen transmission are to be developed through the Gates Foundation Grand Challenges for Global Health (GCGH) projects managed by the Foundation for NIH (FNIH). Therefore, there is a need to assist in addressing the requirements to be considered before deploying the new malaria and dengue vector control methods.

e) The availability of funding opportunities: The Gates foundation funded recently seven projects as part of the Grand Challenges for Global Health (GCGH) for five years for a total about US$ 54.0 million to develop innovative vector control strategies based on genetic and chemical technologies. It also has funded Liverpool School of Tropical Medicine (LSTM) for five years (US$ 50 million) for developing vector control strategies based on improvement of existing chemical insecticides and use of decision support system (DSS) to improve the planning of vector control strategies. These two vector control projects (GCGH and IVCC) are focusing on mosquito-borne diseases (dengue and malaria).

f) Several other funding opportunities are also available for dengue and malaria control (Global Fund, Bush and Blair Presidential initiatives, USAID, Wellcome Trust, European Union) that can potentially boost TDR efforts.

Opportunities for research on Chagas disease vectors control are supported by:

a) The existence of applied field research that is coordinated with ongoing control activities and the availability of highly qualified research groups in the endemic countries


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b) The presence of networks of collaborators (e.g. Chagas disease intervention activities: CDIA-EC; The European Commission-Latin American Network for research on the biology and control of Triatominae: ECLAT network) to create synergies for research, capacity building, and transfer of technology in collaboration with PAHO and TDR

c) The Reduviid bugs genome sequencing in progress

Moreover, recent advances in genomics and molecular biology have increased the technical feasibility of developing new environmentally safe insecticides and alternative approaches to vector control (e.g. genetic control methods) for interrupting the cycle of transmission of some of the insect-borne diseases. However, there is the need to promote the next steps in each of the disease vectors cases. For African trypanosomiasis and Chagas disease, international consortia are needed to initiate, coordinate, and facilitate their respective vector genome research. For malaria and dengue, there are opportunities to assist the efforts of a philanthropic organization that is funding the feasibility of the genetic and chemical control approaches.


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3. COMPARATIVE ADVANTAGE

3.1. TDR EXPERIENCE

TDR has the following proven comparative advantages:

3.1.1. Proven Technical and field experience

The success stories in vector control include the large scale testing and validation of the insecticide treated bed nets for malaria control; the use of Bacillus thuringiensis for onchocerciasis vector control; Bacillus sphaericus for lymphatic filariasis Culex-transmitted control; and traps for tsetse fly control. More recently, they include the genetic engineering of pathogen-refractory mosquitoes, and the facilitation of the Anopheles gambiae genome-sequencing project.

3.1.2. Demonstrated stewardship

Convening power for agenda setting: TDR has convened in August 2002 a scientific working group meeting on insect-disease vectors and human health1 that defined the issues and challenges of vector control and recommended new research directions.

TDR has also published several reviews on vector control including:

a) "A review of entomological sampling methods and indicators for dengue vectors": http://www.who.int/tdr/publications/publications/dengue_vectors.htm;

b) "Strategic review of traps and targets for tsetse and African trypanosomiasis control": http://www.who.int/tdr/publications/publications/tsetse_traps.htm

c) “Bridging Laboratory and Field Research for Genetic Control of Disease Vectors”: http://library.wur.nl/frontis/disease_vectors/index.html

d) Ethical, legal, and social issues of genetically modified disease vectors in public health: http://www.who.int/tdr/publications/publications/seb_topic1.htm

These scientific working meetings and reviews and the resulting publications illustrate the capacity of TDR to contribute to the global agenda setting.

Catalytic power: The TDR catalytic role in vector research is expressed through examples such as the malaria vectors genetic transformation network, the Anopheles gambiae genome-sequencing consortium, and the IGGI consortium. In all these activities, TDR provided also a guiding and facilitating role besides the seed-funding of activities.

1 http://www.who.int/tdr/publications/publications/insect_vectors.htm


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3.1.3. Capacity building capabilities in developing countries

TDR is renowned for its achievements in capacity building and networking. Support for the bioinformatics and functional genomics training centres in Thailand (for Asia) and Mali (for Africa) and the Biology of Disease vectors course are examples among the most recent achievements in the improvement of the technical standing of vector researchers in DECs.

TDR's technical and field experience, demonstrated stewardship, and capacity building capabilities demonstrate its potential to provide guidance and facilitation for improving vector control methods.

3.2. SYNERGIES WITH OTHER ORGANIZATIONS

The TDR partners in the activities covered by this business line are the research and control institutions worldwide, and the international research supporting/funding organizations. More specifically, for research on African trypanosomiasis and Glossina genomics, the partners include the Sanger Centre (UK) for the sequencing of Glossina m. morsitans with funding support from Wellcome Trust. They also comprise the French sequencing centre "Genoscope" in collaboration with Institut de Recherche pour le Développement (IRD) for the sequencing of several thousands of full-length cDNAs of Glossina p. gambiensis. The RIKEN Genomic Sciences Center (Japan) contributes by sequencing the tsetse symbionts Wigglesworthia and Sodalis genomes and by generating 100,000 BAC-ends and 10,000 full-length cDNAs for Glossina sequencing preparatory activities. Moreover, the partnership involves the Yale University School of Medicine (USA), the Liverpool School of Tropical Medicine (UK), IRD (France), and the South African National Bioinformatics Institute (SANBI) for the generation and normalization of the Expressed Sequenced Tags (ESTs) and Bacterial Artificial Chromosomes (BAC) libraries to be used to facilitate the sequencing processes. SANBI is also playing a coordinating role for the functional annotation of genome and transcriptomes. In addition to the institutes directly involved in the genomics activities, research institutes from Kenya, Uganda, and Tanzania along with control departments in WHO/AFRO and WHO/HQ are also contributing to the global effort of the Consortium by facilitating the mobilization of the tsetse research and control communities for the use of the genome data. Other potential partners for the African trypanosomiasis research activities are the Pan African Tsetse and Trypanosomiasis Eradication Campaign (PATTEC) and the International Atomic Energy Agency (IAEA).

The Gates Foundation and the Foundation for NIH already agreed to collaborate with TDR and other interested parties to address the requirements to be considered before the genetically-modified malaria and dengue vectors can be deployed in the open environment. A Memorandum of Understanding is being developed for this collaboration that would address the development of guiding principles for containment of genetically-modified vectors and


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coordination of the global efforts. Attempts will also be made to coordinate the malaria and dengue vector research activities with The Innovative Vector Control Consortium (IVCC/LSTM).

A joint collaboration has started with the University of Geneva through "Interdisciplinary Biosafety Network" (RIBios) for training DECs investigators in biosafety. The first course was organized in Mali for the West African francophone researchers.

Further collaboration should be investigated to improve the synergies between TDR and the Consultative Group on International Agricultural Research (CGIAR) and its programme on System Wide Initiative on Malaria and Agriculture (SIMA) in the area of research on vector-borne diseases in relation to environmental conditions (e.g. water-associated vector-borne diseases and agriculture). In addition, there is the need to establish collaboration with the USAID-funded Research Triangular Institute (RTI) International programmes on Environmental Health (Environmental Health Project: EHP; and Integrated Vector Management project: IVM) and Risk assessment, particularly for malaria and dengue vector control.

For Chagas disease research, there is already a long-standing collaboration between PAHO and TDR for research on vector biology and control that needs to be strengthened and sustained. This collaboration should be extended to the existing networks (ECLAT, CDIA) on Chagas disease vector biology and control. The European Commission will also be approached for collaboration about Chagas disease vector research.

The activities in this BL will be built mostly (and whenever possible) on existing networks in order to develop complementarities. The WHO Departments and Regional Offices and countries will also be involved in the partnership.

These different partnerships will foster synergy between research and control; field and laboratory; public and private; and north and south for the improvement of existing vector control methods and the development and evaluation of innovative vector control approaches. TDR role is to facilitate the generation of improved and innovative vector control methods for the prevention of neglected diseases by supporting activities by networks of investigators. TDR support is needed to catalyze these activities given its international WHO-based mandate, neutrality, and long-term commitment.


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4. ACTIVITIES AND END PRODUCTS

4.1. KEY ACTIVITIES

The following activities will be undertaken throughout the course of this business line:

Specific objective 1:

1.1. Improving large-scale mass trapping of tsetse flies

a) From 2008-2011: Funding research grants to networks of investigators to generate and test improved odour baits and odour release systems for various tsetse species (particularly the Palpalis and Fusca groups) and to limit colour fading, in order for enhancing the effectiveness of traps and screens for HAT vector control

b) From 2008-2012: Funding research grants to networks of investigators for generating and exploiting knowledge on tsetse population genetics and dispersal and for developing and evaluating tailored methods of packaging the tsetse control means for large-scale deployment of traps and screens

1.2. Facilitating the generation and exploitation of Glossina genome data

a) From 2007-2011: Seed-funding preparatory activities for the genome sequencing such as generating and sequencing ESTs, exchanging information, supporting workshop for annotation of the genome sequence and organizing regular meetings of the IGGI Consortium. Additional activities include funding of bioinformatics and functional genomics courses to allow DECs to acquire the knowledge and skills necessary to exploit Glossina genome data for innovative vector control.


2.1. Addressing the requirements for deployment of malaria and dengue vectors genetic and chemical control methods

a) From 2007-2013: Supporting activities to develop guidelines and principles on the design and performance of minimum risk field research; Develop criteria to identify and prepare the potential release sites; Conduct studies on biosafety, efficacy and risk/benefit evaluation; Develop criteria and test methods for environmental monitoring; Provide the basis for collection of data on malaria and dengue vector biology, ecology, behaviour and genetics addressing safety in the field; and Providing basis for policy making of relevant scientific, legal, ethical and social issues (ELSI).

b) Additional activities will concern building capacity in DECs for biosafety and efficacy evaluation of the control methods and assessment and management of


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biosafety and set up and management of regulatory bodies for ethical and biosafety reviews of genetic control strategies.

2.2. Improving methods for packaging integrated malaria vector control approaches

a) From 2008-2012: Funding research grants to networks of investigators for generating and exploiting knowledge on malaria transmission dynamics, vector biology, behaviour, ecology, resistance to insecticides and environmental conditions for developing and evaluating tailored methods of packaging integrated malaria vector control approaches with the existing means (indoor residual spraying, ITMs, IVM, environmental management..)

2.3. Improving methods for targeted and integrated dengue vector control approaches

a) From 2008-2012: Funding research grants to networks of investigators for generating and exploiting knowledge on dengue transmission thresholds, vector population genetics, dynamics, and dispersal for developing and evaluating optimal targeted and integrated approaches for source reduction and transmission suppression.


3.1. Developing improved methods for the prevention of re-infestation by triatomine bugs

a) From 2008-2012: Support research activities to develop molecular markers and generate and exploit knowledge about peridomiciliary and sylvatic triatomine bugs population genetics, dynamics, and dispersal for developing methods for the identification of the origin of re-infestation and for the prevention of re-infestation

3.2. Developing new methods for control of Chagas disease vectors

a) From 2008-2013: Support research activities for the development and evaluation of alternative control approaches against Chagas disease vectors in domestic and peridomestic situations. The possible methods to explore include (but are not limited to) habitat manipulation, biological control, symbionts based genetic modification.

4.2. END-PRODUCTS


1.1. Improving large-scale mass-trapping system of tsetse flies

a) Improved odour baits and odour release system developed and tested by 2011

b) New improved large-scale tsetse mass-trapping methods developed and evaluated by 2012


a) Tsetse genome sequence data generated by 2010


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b) DECs investigators trained in functional genomics and exploiting the Glossina genome data by 2012



a) Genetic and chemical control methods evaluated for biosafety, efficacy, and risk/benefit by 2013


a) Improved methods for integrated malaria vector control approaches developed and evaluated by 2012


a) Improved methods for optimal targeted and integrated approaches for dengue vector source reduction and dengue transmission suppression developed and evaluated by 2012



a) Methods developed for the identification of the origin of re-infestation by 2010

b) Improved methods developed for preventing re-infestation by Chagas disease vectors by 2012


a) New methods for Chagas disease vector control developed and evaluated by 2013

4.3. INTERIM IMPLEMENTATION MILESTONES

The implementation plan is represented in the GANTT chart attached (in annex 1) as follows:

Preparatory phase: Key priority areas of work and modus operandi for the networks and the Scientific Advisory Committee (SAC) defined through consultation by early 2007 and following the finalization of the work plan and the launch of a call for applications, two to three functional research networks per objective selected by the SAC by the end of 2007.

1.1. Improving large-scale mass-trapping system of tsetse flies

a) Highly attractive odours identified by 2010;


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b) Knowledge gathered and published about tsetse population genetics and dispersal by 2010; Improved odour baits and odour release systems for HAT vectors developed and evaluated by 2011;

c) Improved methods developed from knowledge exploitation for large-scale tsetse mass-trapping by 2012.


a) Glossina genome sequencing completed by 2008;

b) Glossina genome sequence annotated and published by 2010;

c) DECs investigators trained and undertaking bioinformatics and functional genomics activities by 2011.


a) Potential release sites for genetically modified vectors identified and characterized by 2010;

b) ELSI considerations addressed by 2011;

c) DECs investigators trained in assessment and management of biosafety and set up and management of regulatory bodies by 2011;

d) Criteria and guidance for field efficacy and biosafety evaluation of genetic and chemical control methods of malaria and dengue vectors established and applied by 2012;

e) Genetic and chemical vector control methods field evaluated for biosafety and efficacy by 2013.


a) Knowledge gathered and published about malaria vectors biology, ecology, and resistance to insecticides by 2010;

b) Improved methods developed from knowledge exploitation for integrated malaria vector control approached by 2012.


a) Knowledge gathered and published about dengue transmission and dengue vector population genetics, dynamics, and dispersal by 2010;

b) Improved methods developed from knowledge exploitation for targeted and integrated dengue vector source reduction and transmission suppression by 2012.



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a) Molecular markers developed and used for Chagas disease vector population biology studies by 2010;

b) Knowledge gathered and published about vector population dynamics and dispersal and used to develop methods to assess the origin of re-infestation by 2011;

c) Improved methods developed from knowledge exploitation and evaluated for the prevention of re-infestation by Chagas disease vectors by 2012.


a) New alternative methods for Chagas disease vector control developed by 2011;

b) New developed vector control methods evaluated for field efficacy and safety by 2013.

Evaluation and follow up phase: At least one meeting of the Advisory committee, one meeting, and one site visit per network will be conducted yearly to regularly assess and follow up the performance of the networks. There will also be an internal TDR annual review of the implementation of the business line activities.

Implementation and management strategy

The mechanism to be used for the implementation of the activities will be a different approach to the steering committee review of investigator-initiated proposals. It will be based on commissioned research to small networks (preferably already existing ones) to deliver a product in response to well defined needs identified through consultation. The networks will be composed of multidisciplinary groups of investigators from different institutions and/or Regions that will work complementarily to achieve a defined goal. Two to three networks per objective involving worldwide experts and resources will be funded for 3+2 years each. TDR Secretariat will manage and facilitate the coordination of the activities of the networks. The overall performance will be measured through annual review of the progress of the activities of the networks and annual review of the implementation of the business plan.

The details about priority areas of work, modus operandi, and criteria for selection of the networks, composition and method of work of the Scientific and Advisory Committee (SAC) will be worked out in a consultative meeting (planned from 23-24 April 2007) that will involve research experts, stakeholders, and various partners including WHO HQ departments and Regions. A detailed work plan for the BL and a call for applications for networks formation will be produced following the consultation meeting. It is expected that the SAC will meet late in 2007 to select on a competitive basis the networks in response to the call for applications. The activities of the networks are expected to start in early 2008.


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Interfaces with WHO/TDR related entities

The activities in this BL will be undertaken in coordination with WHO HQ Departments and Regions, and in strong collaboration with DECs research and control services.

More specifically WHO/NTD Department, AFRO, and EMRO will have an important role to play in the implementation of specific objective 1. Comparatively, WHO/NTD and PAHO will be more involved in objective 3, while the implementation of objective 2 will involve WHO/NTD, GMP, and the different WHO Regions endemic for malaria and dengue.

Interactions will be developed with existing Regional or country programmes in relation to disease vector control. Examples of such programmes include Pan African Tsetse and Trypanosomiasis Elimination Campaign, Chagas disease intervention activities in Latin America and the Asian Regional Dengue Research Network.


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5. FUNDING

5.1. RESOURCE REQUIREMENTS

US $ x 1000

Objective Description 2008 2009 2010 2011 2012 20131 HAT vector control 950 950 1,000 1,000 400 -

1.1. Improving tsetse mass-trapping 800 800 850 850 400 - 1.2. Glossina genome sequencing 150 150 150 150 - -

2 Malaria and dengue vector control 1,100 1,200 1,225 1,125 900 400 2.1 Requirements for GM vectors depl. 400 400 425 425 400 400 2.2 Improving integrated malaria VC 400 450 450 400 300 - 2.3 Improving targeted dengue VC 300 350 350 300 200 - 3 Chagas Vector Control 650 650 650 550 450 250

3.1 Origin of T. bugs reinfestation 350 350 350 300 200 - 3.2 Methods for Chagas disease VC 300 300 300 250 250 250

Evaluation and follow up activities 125 125 125 125 100 100

Activities 2,825 2,925 3,000 2,800 1,850 750Personnel Costs 537 537 537 537 537 537

No. of professional staff 2 2 2 2 2 2No. of support staff 1 1 1 1 1 1

Total 3,362 3,462 3,537 3,337 2,387 1,287

5.2. RATIONALE FOR RESOURCES REQUIRED

The funds will be used to support:

a) Research grants to networks to deliver the needed products (new and improved control methods, capacity building and transfer of technology);

b) Meetings of networks and of the Scientific Advisory Committee

c) Site visits for follow up and coordination of the activities

Elements for budget justification (from historical examples):

1.1. Improving tsetse mass trapping

a) Developing improved odour baits and odour release system: Funding of about two research networks (West-central, and south-east Africa) for identifying various odours and testing their attractiveness for different tsetse fly species (US$ 400,000 first year)

b) New improved large-scale tsetse mass trapping methods: Funding of about two research networks (West-central and south-east Africa) for generating and exploiting


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knowledge on tsetse population genetics and dispersal for developing and evaluating tailored methods of tsetse mass trapping (US$ 400,000 for the first year)

1.2. Glossina genome sequencing: Seed-funding activities for convening meetings of the IGGI consortium; supporting preparatory sequencing activities (generating and sequencing of ESTs, workshop for annotation); and functional genomic courses (US$ 150,000 for first year)

2.1. Requirements for deployment of genetic and chemical control methods: Support a working group for the development and review of containment guidelines document; Fund research groups for gathering biological and ecological information on the potential sites and conducting studies on biosafety, efficacy, and risk/benefit evaluation; Funding training of DECs investigators in assessment and management of biosafety, and set up and management of regulatory principles (US$ 400,000 for the first year)

2.2. Improving integrated malaria vector control: Funding of about two research networks to generate and use scientific knowledge to develop and evaluate methods for improved integrated principles for malaria vector control (US$ 400,000 for the first year)

2.3. Improving targeted dengue vector control: Funding of about two research networks to generate and use scientific knowledge to develop and evaluate methods for improved targeted and integrated principles for dengue vector control (US$ 300,000 for the first year)

3.1. Preventing Triatomine bugs re-infestation: Funding of about two research networks to develop markers, generate, and use scientific knowledge to develop methods for the identification of the origin of re-infestation and for preventing re-infestation (US$ 350,000 for the first year)

3.2. New alternative methods for Chagas disease vector control: Funding of about two research networks to develop new vector control methods (US$ 300,000 for the first year)

4. Evaluation and follow up: Funding of the SAC and networks annual meetings, expert visits to different sites, coordination activities (US$ 125,000 for the first year)


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6. RISKS

Technical

A major issue for the use of genetically modified malaria and dengue vectors as public health control tool is the proper assessment of efficacy and safety for human and the environment. It needs to be demonstrated on a sufficiently long period and under different epidemiological/ environmental conditions in order for the public and the media to be confident in the results. Thus, there may be the need for more efficacy and biosafety assessment studies on longer duration to convince the public.

In terms of addressing the requirements to be considered before the genetically-modified malaria and dengue vectors can be deployed in the field, the following ethical, legal, and social issues that are gender sensitive should be addressed appropriately:

- Ensuring that all parties with legitimate concerns have mechanisms for including their input into the proposed GM vectors control programs

- Including translation of risk assessment procedures into language(s) that are easily understood by the affected communities,

- Consent should be obtained from the communities involved and the specific mechanisms to obtain individual and group consent need to be developed for public health interventions

The measures that would be undertaken to ensure that these issues are properly addressed include ensuring a good representation and input from adequate gender balance and special efforts to obtain them.

The development and field validation of new control methods for Chagas disease may also take longer to complete because of the need for enough proof to convince the public.

Financial

There might be financial constraints that however could be minimized through the development of appropriate synergies with the partners. Alternative solutions to financial limitations include rescheduling of activities such as those dealing with the development of new control methods or reducing the scope of some activities.

Environmental

The involvement of the DECs researchers and control services and other stakeholders (e.g. NGOs) in the different steps of the activities of the networks will facilitate taking in account the needs of the countries. In addition, an open access of the public and the media to the data as they are generated will also facilitate the building of confidence in the scientific results and the researchers. As the different activities would be implemented with the support of external advisers and have for some of them capacity building aspect embedded in them,


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we do not expect major human resources problems.

Project execution related

We anticipate that the periodic review of successes and failures of the networks and of the implementation of the business plan will allow timely remediation to potential problems that might occur during the course of the implementation of the projects.

ANNEX

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