Abstract
BackgroundHookworm is a major contributor to worldwide disease burden with over 230 million people infected. It has been identified as one of the Neglected Tropical Diseases that can be controlled and even eliminated through mass drug administration and other effective interventions. Mathematical models have shown that hookworm can only be eliminated via a vaccine. Controlled Hookworm Human Infection (CHHI) models can facilitate rapid development of vaccines and drugs.MethodsAs a first step towards the establishment of CHHI in Africa, we held a stakeholders meeting in Lamberene, Gabon from 10 to 11 November 2019.ResultsDiscussions revolved around the roles of the different regulatory institutions concerned; the need to strengthen existing regulatory capacity and the role of legislation; creating Gabon-specific ethical guidelines to govern Controlled Human Infection (CHI) studies; development of a study protocol; consideration of cultural and social peculiarities; the need for regular joint review meetings between interested parties throughout the process of protocol implementation; and participant compensation. Moreover, operational considerations concerning the introduction of CHHI in Gabon include the use of the local strain of hookworm for the challenge infections, capacity building for the local production of challenge material, and the establishment of adequate quality assurance procedures.ConclusionThe workshop addressed several of the anticipated hurdles to the successful implementation of CHHI in Gabon. It is our aim that this report will stimulate interest in the implementation of this model in the sub-Saharan African setting.
Highlights
Hookworm is a major contributor to worldwide disease burden with over 230 million people infected
There was a suggestion that new legislation needs to be created to accommodate controlled human infection, but after extensive discussions, it was deemed not necessary to distinguish Controlled Hookworm Human Infection (CHHI) legislation from the legislation of clinical trials
If the parasite is sufficiently genetically diverse, genetic markers could be used to confirm source of infection, but these can be costly. This will be the first attempt at establishing a CHHI model in Africa. These models have already been established in Europe where they have been improved in such a way that level of infection, measured as egg output, is stable and reaches levels that represent what is found in endemic areas
Summary
Hookworm is a major contributor to worldwide disease burden with over 230 million people infected It has been identified as one of the Neglected Tropical Diseases that can be controlled and even eliminated through mass drug administration and other effective interventions. Hookworm infects around 230 million people worldwide [1], and is hyperendemic in several sub-Saharan countries, some of which have a disease prevalence of a third of the pediatric population [2]. In the Central African region, Gabon is estimated to have the highest prevalence of hookworm infection at 26% [2] (Table 1) Preventative measures such as the mass drug administration of anthelmintic agents i.e. albendazole have already been undertaken their efficacy is questionable [6].
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