02724nas a2200349 4500000000100000008004100001260001200042653003700054653001000091653002300101653002000124653002400144100001200168700001400180700001700194700001400211700001200225700001400237700001300251700001300264700001400277700001600291700001500307700001900322700001500341245016900356856008800525300000800613490000700621520173200628022001402360 2021 d c07/202110aControlled human infection model10aGabon10aNecator americanus10aThe Netherlands10aVaccine development1 aAlabi A1 aHussain M1 aHoogerwerf M1 aMengome C1 aEgesa M1 aDriciru E1 aWammes L1 aKruize Y1 aSartono E1 aAdegnika AA1 aKremsner P1 aYazdanbakhsh M1 aAgnandji S00aEstablishing a controlled hookworm human infection (CHHI) model for Africa: A report from the stakeholders meeting held in Lambaréné, Gabon, November 10-11, 2019. uhttps://archpublichealth.biomedcentral.com/track/pdf/10.1186/s13690-021-00650-z.pdf a1200 v793 a

BACKGROUND: 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. 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.

METHODS: As a first step towards the establishment of CHHI in Africa, we held a stakeholders meeting in Lamberene, Gabon from 10 to 11 November 2019.

RESULTS: Discussions 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.

CONCLUSION: The 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.

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