Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children
NCT ID: NCT03799510
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2018-12-13
2019-08-07
Brief Summary
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Detailed Description
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Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP) conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.
Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a safety evaluation at 24 hrs and 48 hrs, after each injection.
Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before inclusion, and at W9 and W21 during the follow-up.
Blood samples for immune response analysis at D0, W12 and W21.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
Healthy school children with no infectious history of Schistosomiasis receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20).
Sm14
Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
GLA-SE solution
The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.
Group 2
School children with an infectious history of S. haematobium and-or S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) receiving three (3) intramuscular injections of 50 μg Sm14 with 2.5 μg GLA-SE solution at D0, W4, W8 (D=day; W=week). Three-month follow-up (W12, W20).
Sm14
Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
GLA-SE solution
The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.
Group 3
School children with an infectious history of S. haematobium and S. mansoni and pretreated with 1 dose of Praziquantel (2-4 weeks prior to the first vaccine injection) not receiving vaccine. Control group.
No interventions assigned to this group
Interventions
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Sm14
Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
GLA-SE solution
The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Residence in the area during the period of the study.
* Free of obvious/severe health problems except schistosomiasis, as established by clinical examination.
* Written informed consent to participate obtained from subject's parents or legal guardian.
* Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests.
* Treated with 40mg/kg Praziquantel (PZQ) before inclusion (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium
* Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission.
* Children Groups 2 \& 3: infected with mansoni or/and haematobium schistosomiasis.
* Child under 20kg of body weight
* Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period.
* Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs.
* Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease.
* Knowledge of non-infectious chronic disease
* Known acute disease.
* Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled.
8 Years
11 Years
ALL
Yes
Sponsors
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Orygen Biotecnologia SA
UNKNOWN
Biomedical Research Center EPLS
OTHER
Access to Advanced Health Institute (AAHI)
OTHER
Oswaldo Cruz Foundation
OTHER
Responsible Party
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Principal Investigators
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Miriam Tendler, MD, PhD
Role: STUDY_CHAIR
Oswaldo Cruz Foundation
Modou DIOP, MD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS)
Gilles RIVEAU, PharmD, PhD
Role: STUDY_DIRECTOR
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS).
Anne-Marie SCHACHT, CRA
Role: STUDY_DIRECTOR
Biomedical Research Center ESPOIR POUR LA SANTE (BRC-EPLS).
Locations
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Biomedical Research Center EPLS
Saint-Louis, , Senegal
Countries
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References
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Moser D, Tendler M, Griffiths G, Klinkert MQ. A 14-kDa Schistosoma mansoni polypeptide is homologous to a gene family of fatty acid binding proteins. J Biol Chem. 1991 May 5;266(13):8447-54.
Ramos CR, Spisni A, Oyama S Jr, Sforca ML, Ramos HR, Vilar MM, Alves AC, Figueredo RC, Tendler M, Zanchin NI, Pertinhez TA, Ho PL. Stability improvement of the fatty acid binding protein Sm14 from S. mansoni by Cys replacement: structural and functional characterization of a vaccine candidate. Biochim Biophys Acta. 2009 Apr;1794(4):655-62. doi: 10.1016/j.bbapap.2008.12.010. Epub 2008 Dec 25.
Coler RN, Bertholet S, Moutaftsi M, Guderian JA, Windish HP, Baldwin SL, Laughlin EM, Duthie MS, Fox CB, Carter D, Friede M, Vedvick TS, Reed SG. Development and characterization of synthetic glucopyranosyl lipid adjuvant system as a vaccine adjuvant. PLoS One. 2011 Jan 26;6(1):e16333. doi: 10.1371/journal.pone.0016333.
Santini-Oliveira M, Coler RN, Parra J, Veloso V, Jayashankar L, Pinto PM, Ciol MA, Bergquist R, Reed SG, Tendler M. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. 2016 Jan 20;34(4):586-594. doi: 10.1016/j.vaccine.2015.10.027. Epub 2015 Nov 10.
Lambert SL, Yang CF, Liu Z, Sweetwood R, Zhao J, Cheng L, Jin H, Woo J. Molecular and cellular response profiles induced by the TLR4 agonist-based adjuvant Glucopyranosyl Lipid A. PLoS One. 2012;7(12):e51618. doi: 10.1371/journal.pone.0051618. Epub 2012 Dec 28.
Tendler M, Almeida MS, Vilar MM, Pinto PM, 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 Nov 21;3(4):121. doi: 10.3390/tropicalmed3040121.
Other Identifiers
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Sm14 Phase 2b - Sn
Identifier Type: -
Identifier Source: org_study_id