Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults

Santini-Oliveira, Marília; Coler, Rhea N.; Parra, Juçara de Carvalho; Veloso, Valdiléa G.; Jayashankar, Lakshmi; Pinto, Patrícia M; Ciol, Márcia A.; Bergquist, Robert; Reed, Steven G.; Tendler, Míriam

doi:10.1016/j.vaccine.2015.10.027

Cited by 96 publications

(97 citation statements)

References 44 publications

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“…A phase III trial to assess if the combination of rSh28GST and praziquantel would help lower pathologic episodes of S. haematobium infection in infected children was carried out from 2009 to 2012; the findings of which have not yet been published [10]. Similarly, phase I clinical trial data on tolerability and specific immune responses after vaccination of adult, male volunteers in a non-endemic area for schistosomiasis with rSm14/GLA-SE has also shown that the vaccine formulation is safe and immunogenic against schistosomiasis (S. mansoni)[38]. Phase I trial for Sm-TSP-2 (S. mansoni) has been initiated in 2014 and is ongoing [10].…”

Section: Current Status Of Schistosomiasis Vaccinesmentioning

confidence: 99%

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials

Siddiqui

2017

Trends in Parasitology

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Mass anti-parasitic drug administration programs and other control strategies have made important contributions in reducing the global prevalence of helminths. Schistosomiasis, however, continues to spread to new geographic areas. Advent of a viable vaccine and its deployment coupled with existing control efforts is expected to make a significant headway towards a sustained schistosomiasis control. In 2016, Science ranked schistosomiasis vaccine as one of the top 10 vaccines that need to be urgently developed. A vaccine that is effective against geographically distinct forms of intestinal/hepatic and urinary disease is essential to make a meaningful impact in global reduction of disease burden. In this review we focus on salient features of schistosomiasis vaccines in different phases of the clinical development pipeline and highlight the Sm-p80-based vaccine which is now being prepared for human clinical trials.

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Section: Current Status Of Schistosomiasis Vaccinesmentioning

confidence: 99%

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials

Siddiqui

2017

Trends in Parasitology

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“…7), and for its intended use as a vaccine against schistosomiasis, and potentially bladder cancer, glycosylation can interfere with the antigen's immunogenicity. In addition, all of the immunogenicity and toxicity tests done to date with Sm14 were done using an E. coli-produced antigen, which also lacks glycosylation [33,34]. Therefore, the first step in characterizing the Sm14 produced by P. pastoris was to look for potential glycosylation of the final purified product.…”

Section: Characterization Of Sm14 Expressed By P Pastorismentioning

confidence: 99%

“…Clinical trials have been initiated for the use of this P. pastoris derived Sm14 in both animals and humans [33]. The Pichia produced SM14 antigen immunized with GLA adjuvant induced a broad IgG response with no adverse effects outside of self-limited reactions at the site of injection [34]. The Sm14 antigen in conjunction with the Sm29 antigen has been reported to provide significant protection against S. mansoni in mice [35].…”

Section: Characterization Of Sm14 Expressed By P Pastorismentioning

confidence: 99%

Process development for production and purification of the Schistosoma mansoni Sm14 antigen

Damasceno

Ritter

Batt

2017

Protein Expression and Purification

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“…Recombinant Sm14, produced in Pichia pastoris , was formulated with glucopyranosyl lipid adjuvant stable emulsion (GLA-SE) and has completed a phase I clinical trial (ClinicalTrials.gov Identifier: NCT01154049), showing that the adjuvanted Sm14 product is well tolerated, safe and highly immunogenic [39]. Vaccination stimulated anti-Sm14-IgG antibodies as well as a strong Th1 biased response as evidenced by γ-interferon production on re-stimulation of cells from individuals in vaccinated subjects [38].…”

Section: Introductionmentioning

confidence: 99%

Development of a schistosomiasis vaccine

Molehin

Rojo

Siddiqui

et al. 2016

Expert Review of Vaccines

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Summary Schistosomiasis is a neglected tropical disease (NTD) of public health importance. Despite decades of implementation of mass praziquantel therapy programs and other control measures, schistosomiasis has not been contained and continues to spread to new geographic areas. A schistosomiasis vaccine could play an important role as part of a multifaceted control approach. With regards to vaccine development, many biological bottlenecks still exist: the lack of reliable surrogates of protection in humans; immune interactions in co-infections with other diseases in endemic areas; the potential risk of IgE responses to antigens in endemic populations; and paucity of appropriate vaccine efficacy studies in nonhuman primate models. Research is also needed on the role of modern adjuvants targeting specific parts of the innate immune system to tailor a potent and protective immune response for lead schistosome vaccine candidates with the long-term aim to achieve curative worm reduction. This review summarizes the current status of schistosomiasis vaccine development.

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Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults

Cited by 96 publications

References 44 publications

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials

Process development for production and purification of the Schistosoma mansoni Sm14 antigen

Development of a schistosomiasis vaccine

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