English Questionnaire

Standard Template for a Candidate Demonstration Project Note: the questions with asterisk should be filled. 1.* Title of the project: Improving health quality and wellbeing of the economically marginalized populations in Southeast Asia: An initiative towards the introduction of a human hookworm vaccine (IIHHVac) 2.* Submitted by: 3.* Target disease or health condition: (Focus on type II and III diseases and special RandD needs of developing countries in type I diseases where there is an identified health technology gap.) Hookworm disease 4.* The suggested health technology that project seeks to develop: (e.g. medicine; diagnostic test; medical device; vaccine etc.) Hookworm vaccine 5.* Project summary: (Maximum 500 words) Hookworm disease is the leading cause of iron deficiency anemia in the world’s poorest regions [1]. It is a major socioeconomic and public health concern. It is estimated that 600 million people are chronically infected, with up to135,000 deaths annually [2]. Most infections occur in the Asian region (60-70million people in each), followed by Nigeria and the Democratic Republic of Congo in Africa and Brazil (30-40 million people in each) [3]. The economic burden of chronic hookworm infection is estimated at 4.5 million DALYs annually [4] and is among the most important neglected tropical disease [5]. Southeast Asia (SEA) has a large percentage of populations living in rural and remote areas where hookworm infection is common [6]. These areas generally have poor sanitation and access to untreated water, which increase the opportunity of hookworm transmission and infection. Hookworm infection has been associated with impaired learning and decrease in productivity [7]. Eradicating hookworm disease will have the potential to improve the health quality and well-being of the economically marginalized communities living especially in the remote areas of SEA. Here, we propose an initiative to explore the possibility of introducing hookworm vaccine to the vulnerable communities in the SEA using select communities in Malaysia as a starting point. Hookworm disease is highly endemic in certain communities in Malaysia with prevalence of 3.0–44.7%. It is notable especially amongst the underprivileged or minority communities such as the Orang Asli (aborigine) children [8-11], amongst Indians living in estates [12], amongst multiracial communities living in the squatter areas [13] and in poor Malay living in traditional villages [14, 15] in which sanitation is poor. The excellent availability of research infrastructure, efficient technical support coupled with the presence of local expertise with well-connected regional counterparts makes Malaysia an ideal study site. The model developed and knowledge gained from the study can be expanded to other SEA countries, where hookworm disease is highly endemic. Published reports have suggested that the Sabin Vaccine Institute (SVI) at Baylor College of Medicine, Houston, Texas, USA has developed lead vaccine targets against the hookworm disease. The Phase II trials of the vaccine started in November 2012 with volunteers receiving 3 injections over 4 months and will be monitored for an additional 12 months (http://www.sabin.org/updates/pressreleases/clinical-trials- first-ever-human-hookworm-vaccine-advance). In anticipation of the need to undertake similar studies in the SEA, we propose here to: 1) Undertake a study to update the epidemiology, prevalence and risk factors of hookworm infections targeted for vaccination among the economically disadvantaged communities in rural areas of Peninsular Malaysia with focus on the Orang Asli communities and the native communities of Sarawak and Sabah in Malaysia. 2) Identify potential cohorts for the eventual vaccine trials 3) Estimate the cost-impact of vaccine introduction among the identified communities 4) Determine community perception and acceptance of vaccine 5) Identify, characterize and full genome sequencing of vaccine-targeted hookworm species from the identified communities 6) Develop diagnostic tools and competency to detect the various hookworm species needed for eventual assessment of vaccine efficacy. 7) Identify additional potential vaccine targets from hookworm species identified from the communities 6.* Public health need that the proposed project aims to address: (Explain the public health need in terms of burden of disease; prevalence; incidence; fatality rate; geographical spread; current interventions and their limitations; and what proposed new technology would change in terms of disease prevention, control, diagnosis, treatment etc. If detailed information is not possible at present then please provide some basic level information)(Maximum 400 words) Human hookworm infection is caused by blood feeding nematode of the genus Ancylostoma and the species Necator americanus. The predominant etiology of human hookworm infection is N. americanus whereas A. duodenale occurrence is more scattered [1]. The highest prevalence of hookworm occurs in sub-Saharan Africa and eastern Asia with certain parts of SEA having up to 80% hookworm prevalence [16]. There is also a striking relationship between hookworm prevalence and low socioeconomic status [16] because hookworm causes chronic anemia that can impair neurological and cognitive functions in children, reduce work capacity in adults and adverse outcomes of pregnancy in mother and child [17]. Iron deficiency anemia is the hallmark of hookworm infection and it is associated with about 841,000 deaths and about 35 million DALYs annually [18]. The WHO has proposed that ‘deworming’ with albendazole or mebendazole is the most cost-effective method to reduce childhood morbidity related to chronic intestinal helminth infection [19]. However, there is increasing evidence indicating that deworming may be less effective for hookworm than other intestinal helminth infections. For example, deworming typically achieves total clearance or substantial reductions in worm burdens and egg counts for ascariasis but high failure rates have been reported for hookworm with an average cure of only 15% [20]. Furthermore, efficacy of mebendazole has been reported to diminish over time after prolong and repeated administration [21], suggesting that it could be due to drug resistance. Concerns of widespread drug resistance strongly suggest that we cannot rely solely on deworming as a means to control human hookworm. Hence, a new human hookworm vaccine that ultimately aims to prevent moderate to heavy hookworm infections that is associated with substantial intestinal blood loss, is proposed. The current leading candidate vaccine is reported to consist of recombinant hookworm antigens that will raise antibodies to protective levels and will interfere with key enzymes of the hookworm life cycle. 7.* Explain which new and innovative approaches and mechanisms to supporting financing and coordination of RandD this project would demonstrate? (This is a very important part to be filled. The idea of these demonstrations projects is “to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken” (WHA66.22). 66th WHA considered these demonstration projects as part of the efforts to “take forward action in relation to monitoring, coordination and financing for health research and development”. The assembly decided to identify such projects that: “(a) address identified research and development gaps related to discovery, development and/or delivery, including promising product pipelines, for diseases that disproportionally affect developing countries, particularly the poor, and for which immediate action can be taken; (b) utilize collaborative approaches, including open- knowledge approaches, for research and development coordination; (c) promote the de-linkage of the cost of research and development from product price; and (d) propose and foster financing mechanisms including innovative, sustainable and pooled funding; (2) The demonstration projects should provide evidence for long-term sustainable solutions.”) (Maximum 300 words) Since the most recent global financial meltdown in 2008, many developed economies have taken longer than expected to recover their financial health. Hence, the engine to propel economic growth now rests in the hands of several rapidly developing regions namely, China, Brazil, India, Southeast Asia and Africa. Coincidentally, these are the regions that are also highly endemic for hookworm disease. The Human Hookworm Vaccine Initiative (HHVI) has already identified promising candidates that can already be developed into an eventual vaccine. SVI which initiated the HHVI has internationally recognized Product-Development- Partnership arrangements with many leading health organizations for the development of safe and effective vaccines against neglected tropical diseases. This approach is filling an important gap by developing inexpensive vaccines to control neglected tropical diseases which have little market value. Moreover, SVI has established a well-rounded model that serves as the blueprint for the development of vaccines for neglected tropical diseases. These include technology transfer and manufacturing to scale up processes for the manufacturing of pilot vaccines under current good manufacturing practices (cGMP). It will allow an almost effortless duplication of technology in a local setting and cost of investment to be minimal. The Malaysian government alone has allocated almost 10% of its annual

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