Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine

Version 1 : Received: 15 October 2018 / Approved: 16 October 2018 / Online: 16 October 2018 (05:02:00 CEST)

A peer-reviewed article of this Preprint also exists.

Tendler, M.; Almeida, M.S.; Vilar, M.M.; Pinto, P.M.; Limaverde-Sousa, G. Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine. Trop. Med. Infect. Dis. 2018, 3, 121. Tendler, M.; Almeida, M.S.; Vilar, M.M.; Pinto, P.M.; Limaverde-Sousa, G. Current Status of the Sm14/GLA-SE Schistosomiasis Vaccine: Overcoming Barriers and Paradigms towards the First Anti-Parasitic Human(itarian) Vaccine. Trop. Med. Infect. Dis. 2018, 3, 121.

Journal reference: Trop. Med. Infect. Dis. 2018, 3, 121
DOI: 10.3390/tropicalmed3040121

Abstract

Schistosomiasis, a disease historically associated with poverty, lack of sanitation and social inequalities, is a chronic, debilitating parasitic infection, affecting hundreds of millions of people in endemic countries. Although schistosomiasis control approach has shown that chemotherapy is capable of reducing morbidity in humans, rapid re-infection is a reminder that the impact of drug treatment on transmission control or elimination initiatives is marginal. In addition, and regardless of more than two decades of well-executed control activities based on large-scale chemotherapy, the disease is expanding in many areas including Brazil. The development of the Sm14/GLA-SE schistosomiasis vaccine is an emblematic open knowledge innovation that has successfully completed Phase I and Phase IIa clinical trials, with Phase II/III trials underway in the African continent and to be followed in Brazil. Discovery and experimental phases were long term achievements leading to a robust collection of data that are strongly supporting the presently ongoing Clinical Phase. This paper reviews the development of the Sm14 vaccine formulated with GLA-SE (Glucopyranosyl Lipid A), from the earlier experimental developments to clinical trials including the recent status of Phase II studies.

Subject Areas

schistosomiasis; vaccine; Sm14; FABP

Comments (1)

Comment 1
Received: 3 May 2020
Commenter: Martin Nelwan (Click to see Publons profile: )
The commenter has declared there is no conflict of interests.
Comment: In this article, the authors described status of the Sm14/CLA-SE schistosomiasis vaccine and its clinical trials for Phase Ia, Phase Ib, Phase IIa, and Phase IIb. A vaccine is an important issue in schistosomiasis as vaccines are unavailable for this disease at present. In this manuscript, the authors describe that chemotherapy could reduce morbidity of schistosomiasis in humans. However, re-infection occurs in endemic areas. In addition, schistosomiasis is expanding in many areas. Therefore, it needs another way to fight this parasite. One of the ways is use of vaccines. In this article, use of the Sm14/CLA-SE vaccine is described. The authors described this vaccine is one of six demonstration projects elected by the World Health Organization (WHO) for independent testing. Others vaccines are such as paramyosin Sm97 and TPI. TPI is triose phosphate isomerase developed by Harvard School of Public Health. Developers of Sm97 are Case Western Reserve University and National Institute of Health. The authors stated that Phase Ia to IIb of the Sm14/CLA-SE vaccine has been conducted. The Phase IIb was conducted in 2018. Results of Phase Ia to IIa were explained in this article, while Phase IIb has not yet had results. However, there is no explanation for the percentage of vaccine results for the Phase Ia to Phase IIa. In my opinion, readers would like to know the percentage result of each stage. Therefore, the percentage for each phase of clinical trials in this article should be described. Other points I suggest the authors to revise the writing style of this article. There are too many long sentences. For example, Page 1, lines 19-21: It is a long sentence (39 words). The authors can split it into two sentences. I suggest, “The development of the Sm14/GLA-SE schistosomiasis vaccine is an emblematic open knowledge innovation that has successfully completed Phase I and Phase IIa clinical trials. In addition, Phase II/III trials are underway in the African continent and to be followed in Brazil.” In addition, I think the authors should write Schistosomiasis as schistosomiasis in the entire manuscript. Page 7, lines 238-241: It is a long long sentence (48 words). Split it into two or three sentences. Where is the Conclusion section? An abstract is not a conclusion. I think the authors should add information regarding the conclusion of this article such as, In conclusion, etc.
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