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Sustainable Development Goals
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POTENCY TESTING FOR THE EXPERIMENTAL NA-GST-1 HOOKWORM VACCINE
hookworm vaccine
potency assay
neglected tropical disease vaccine
probit analysis
Author
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Albert B. Sabin Vaccine Institute. Washington, DC, USA.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine / Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Laboratório de Imunologia Celular e Molecular. Belo Horizonte, MG, Brasil.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine.
Albert B. Sabin Vaccine Institute. Washington, DC, USA / Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Albert B. Sabin Vaccine Institute. Washington, DC, USA.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine / Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Laboratório de Imunologia Celular e Molecular. Belo Horizonte, MG, Brasil.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine / Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Laboratório de Imunologia Celular e Molecular. Belo Horizonte, MG, Brasil.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine.
Albert B. Sabin Vaccine Institute. Washington, DC, USA / Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology, Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine.
Albert B. Sabin Vaccine Institute. Washington, DC, USA.
Clinical Immunology Laboratory. Human Hookworm Vaccine Iniciative. Department of Microbiology. Immunology and Tropical Medicine / Fundação Oswaldo Cruz. Centro de Pesquisas René Rachou. Laboratório de Imunologia Celular e Molecular. Belo Horizonte, MG, Brasil.
Abstract
Over the next decade, a new generation of vaccines will target the neglected tropical diseases (NTDs). The goal of most NTD vaccines will be to reduce the morbidity and decrease the chronic debilitating nature of these often-forgotten infections – outcomes that are hard to measure in the traditional potency testing paradigm. The absence of measurable correlates of protection, a lack of permissive animal models for lethal infection, and a lack of clinical indications that do not include the induction of sterilizing immunity required us to reconsider the traditional bioassay methods for determining vaccine potency. Owing to these limitations, potency assay design for NTD vaccines will increasingly rely on a paradigm where potency testing is one among many tools to ensure that a manufacturing process yields a product of consistent quality. Herein, we discuss the evolution of our thinking regarding the design of a potency assay along these newly defined lines and its application to the release of the experimental Necator americanus-glutathione-S- transferase-1 (Na-GST-1) vaccine to prevent human hookworm infection. We discuss the necessary steps to accomplish the design and implementation of such a new potency assay as a resource for the burgeoning NTD vaccine community. Our experience is that much of the existing information is proprietary and needs to be pulled together in a single source to aid in our overall understanding of potency testing.
Keywords
Efetive dose 50hookworm vaccine
potency assay
neglected tropical disease vaccine
probit analysis
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