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Objectives: Despite evidence of praziquantel's (PZQ) safety for treating schistosomiasis in pregnancy, many countries withhold treatment. Only two randomized controlled trials have investigated PZQ in pregnancy, none involving Schistosoma haematobium., Methods: Pregnant women during the second trimester in Lambaréné (Gabon) were screened for S. haematobium infection using urine microscopy and circulating anodic antigen detection. Participants positive for either test were randomized (3:1) to single-dose PZQ 40 mg/kg during pregnancy versus no treatment during pregnancy. Investigators were blinded for allocation. Primary outcomes were reduction of egg (egg reduction rate [ERR]) and antigen production (infection reduction rate [IRR]) while explorative outcomes included assessment of cure rate, adverse events, maternal hemoglobin levels, maternal anemia prevalence at delivery, pregnancy outcomes, and newborn anthropometric parameters., Results: Of 761 women screened 165 were eligible and randomized (intervention n = 124, control n = 41). Of them, 124 completed the study (n = 90 and n = 34, respectively). Treatment led to a significantly higher ERR (95.0% [91-97%] vs 27.0% [-42-63%]) and IRR (95% [91-97%] vs 56% [14-78%]). Common adverse events were dizziness, nausea, and vomiting. Maternal anemia at delivery was significantly lower in the intervention group (odds ratio: 0.40 [0.16;0.96], P = 0.04). No increased risk for adverse pregnancy outcomes was observed., Conclusions: This first randomized controlled trial investigating PZQ in pregnant women with S. haematobium found PZQ to be safe, effective, and reducing maternal anemia. We recommend treating confirmed infections to prevent morbidity in pregnant women., Competing Interests: Declarations of competing interest The authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Although Schistosoma haematobium infection has been reported to be associated with alterations in immune function, in particular immune hyporesponsiveness, there have been only few studies that have used the approach of removing infection by drug treatment to establish this and to understand the underlying molecular mechanisms., Methods: Schistosoma haematobium-infected schoolchildren were studied before and after praziquantel treatment and compared with uninfected controls. Cellular responses were characterized by cytokine production and flow cytometry, and in a subset of children RNA sequencing (RNA-Seq) transcriptome profiling was performed., Results: Removal of S haematobium infection resulted in increased schistosome-specific cytokine responses that were negatively associated with CD4+CD25+FOXP3+ T-cells and accompanied by increased frequency of effector memory T-cells. Innate responses to Toll like receptor (TLR) ligation decreased with treatment and showed positive association with CD4+CD25+FOXP3+ T-cells. At the transcriptome level, schistosome infection was associated with enrichment in cell adhesion, whereas parasite removal was associated with a more quiescent profile. Further analysis indicated that alteration in cellular energy metabolism was associated with S haematobium infection and that the early growth response genes 2 and 3 (EGR 2 and EGR3), transcription factors that negatively regulate T-cell activation, may play a role in adaptive immune hyporesponsiveness., Conclusions: Using a longitudinal study design, we found contrasting effects of schistosome infection on innate and adaptive immune responses. Whereas the innate immune system appears more activated, the adaptive immunity is in a hyporesponsive state reflected in alterations in CD4+CD25+FOXP3+ T-cells, cellular metabolism, and transcription factors involved in anergy., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)