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<p>An estimated 200 million people are currently infected with schistosomiasis and an additional 800 million reside in high transmission-risk areas in 78 endemic countries. In this report we describe a functional enzymatic assay based on the core calpain antigen (Sm-p80) of the schistosomiasis vaccine, SchistoShield®. A 44 kDa soluble variant of the core Sm-p80 antigen (B7), was assessed for its enzymatic activity using a fluorescent synthetic substrate. Inhibition of the B7 enzymatic activity by Sm-p80-specific antibodies obtained from pre-clinical trials in rodents, non-human primates as well as from participants of the human clinical trials was measured. The B7 enzyme activity followed a Michaelis-Menten-like kinetic behavior. Statistically significant inhibition of the B7 activity was observed by Sm-p80-specific antibodies produced by immunized mice, non-human primates and humans. This quantitative serological assay could be of value in assessing the effectiveness of the SchistoShield® vaccine in human trials in Africa.</p>

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A functional enzymatic assay as potential readout for a clinical trial of a schistosomiasis vaccine

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月13日

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  • Desalegn W. Kifle,
  • Mumtaz Y. Balkhi,
  • Yasuko Ono,
  • Jenn Davis,
  • Naoko Doi,
  • Aryandra Arya,
  • Jiho Kim,
  • Aravindan Kalyanasundaram,
  • Sourav Nandy,
  • Njariharinjakamampionona Rakotozandrindrainy,
  • Bart Staker,
  • Justin Craig,
  • Raphaël Rakotozandrindrainy,
  • Birkneh T. Tadesse,
  • Florian Marks,
  • Lisa Jackson,
  • Darrick Carter,
  • Sean A. Gray,
  • Afzal A. Siddiqui

摘要

An estimated 200 million people are currently infected with schistosomiasis and an additional 800 million reside in high transmission-risk areas in 78 endemic countries. In this report we describe a functional enzymatic assay based on the core calpain antigen (Sm-p80) of the schistosomiasis vaccine, SchistoShield®. A 44 kDa soluble variant of the core Sm-p80 antigen (B7), was assessed for its enzymatic activity using a fluorescent synthetic substrate. Inhibition of the B7 enzymatic activity by Sm-p80-specific antibodies obtained from pre-clinical trials in rodents, non-human primates as well as from participants of the human clinical trials was measured. The B7 enzyme activity followed a Michaelis-Menten-like kinetic behavior. Statistically significant inhibition of the B7 activity was observed by Sm-p80-specific antibodies produced by immunized mice, non-human primates and humans. This quantitative serological assay could be of value in assessing the effectiveness of the SchistoShield® vaccine in human trials in Africa.