Kifle Desalegn W, Kalyanasundaram Aravindan, Molehin Adebayo J, Balkhi Mumtaz Y, Arya Aryandra, Zhang Weidong, Ahmad Gul, Torben Workineh, Carey David, Papin James F, Jackson Lisa A, Gray Sean A, Carter Darrick, Siddiqui Afzal A
Department of Immunology and Molecular Microbiology, Center for Tropical Medicine and Infectious Diseases, Texas Tech University Health Sciences Center, 3601 4th Street, Mail Stop 6591, Lubbock, TX, 79430, USA.
Department of Microbiology and Immunology, College of Graduate Studies, Midwestern University, Glendale, AZ, USA.
Sci Rep. 2025 Jul 2;15(1):23251. doi: 10.1038/s41598-025-05730-6.
Schistosomiasis is a chronic disease that inflicts high morbidity and significant mortality with an estimated 90% of cases occurring in sub-Saharan Africa. Development of a vaccine against schistosomiasis is a major global health goal. The SchistoShield (Sm-p80 + GLA-SE) vaccine has consistently exhibited robust efficacy in non-human primate pre-clinical trials, has recently completed Phase 1 clinical trials in the US and Phase 1b trials are ongoing in Africa. To delineate a potential clinical/parasitological endpoint to measure the efficacy of schistosomiasis vaccine during human clinical trials, we have designed an in vitro schistosomula killing assay using sera collected from SchistoShield-vaccinated baboons and human volunteers from the Phase 1 clinical trial. Sm-p80-specific antibodies produced by immunized non-human primates and humans induced statistically significant larval schistosomula killing ex vivo. This reproducible functional assay has the potential to serve as one of the biomarkers for the effectiveness of the SchistoShield vaccine in human trials in Africa.
血吸虫病是一种慢性疾病，发病率高且死亡率显著，估计90%的病例发生在撒哈拉以南非洲地区。研发一种针对血吸虫病的疫苗是一项主要的全球卫生目标。SchistoShield（Sm-p80 + GLA-SE）疫苗在非人类灵长类动物的临床前试验中一直表现出强大的效力，最近在美国完成了1期临床试验，在非洲正在进行1b期试验。为了确定在人类临床试验期间测量血吸虫病疫苗效力的潜在临床/寄生虫学终点，我们设计了一种体外血吸虫幼虫杀伤试验，使用从接种SchistoShield疫苗的狒狒和1期临床试验中的人类志愿者收集的血清。免疫的非人类灵长类动物和人类产生的Sm-p80特异性抗体在体外诱导了具有统计学意义的幼虫血吸虫杀伤作用。这种可重复的功能试验有可能作为SchistoShield疫苗在非洲人类试验中有效性的生物标志物之一。
