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A new generation of vaccines for the neglected tropical diseases (NTDs) have now advanced into clinical development, with the  Na -GST-1/Alhydrogel Hookworm Vaccine already being tested in Phase 1 studies in healthy adults. The current manuscript focuses on the often overlooked critical aspects of NTD vaccine product development, more specifically, vaccine stability testing programs. A key measure of vaccine stability testing is "relative potency" or the immunogenicity of the vaccine during storage. As with most NTD vaccines, the  Na -GST-1/Alhydrogel Hookworm Vaccine was not developed by attenuation or inactivation of the pathogen ( Necator americanus ), so conventional methods for measuring relative potency are not relevant for this investigational product. Herein, we describe a novel relative potency testing program and report for the first time on the clinical lot of this NTD vaccine during its first 60 months of storage at 2–8°C. We also describe the development of a complementary functional assay that measures the ability of IgG from animals or humans immunized with  Na -GST-1/Alhydrogel to neutralize this important hookworm enzyme. While 90% inhibition of the catalytic activity of  Na -GST-1 was achieved in animals immunized with  Na -GST-1/Alhydrogel, lower levels of inhibition were observed in immunized humans. Moreover, anti- Na -GST-1 antibodies from volunteers in non-hookworm endemic areas were better able to inhibit catalytic activity than anti- Na -GST-1 antibodies from volunteers resident in hookworm endemic areas. The results described herein provide the critical tools for the product development of NTD vaccines.

Advances in neglected tropical disease vaccines: Developing relative potency and functional assays for the Na-GST-1/Alhydrogel hookworm vaccine