Safety and Immunogenicity of rSh28GST Antigen in Humans Phase 1 Randomized Clinical Study of a Vaccine Candidate against Urinary Schistosomiasis 英文参考文献.docVIP

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Safety and Immunogenicity of rSh28GST Antigen in Humans Phase 1 Randomized Clinical Study of a Vaccine Candidate against Urinary Schistosomiasis 英文参考文献.doc

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Safety and Immunogenicity of rSh28GST Antigen in Humans Phase 1 Randomized Clinical Study of a Vaccine Candidate against Urinary Schistosomiasis 英文参考文献

SafetyandImmunogenicityofrSh28GSTAntigenin Humans:Phase1RandomizedClinicalStudyofaVaccine CandidateagainstUrinarySchistosomiasis GillesRiveau1*,DominiqueDeplanque2,3,FranckRemoue′1,Anne-MarieSchacht1,HubertVodougnon2, MoniqueCapron1,MichelThiry4,JosephMartial4,ChristianLibersa2,3,Andre′ Capron1 1Inserm – Universite′ Lille 2, Institut Pasteur de Lille, Lille, France, 2Inserm CIC-CRB 9301, CHRU, Lille, France, 3Universite′ Lille – Nord de France, De′partement de PharmacologieMe′dicale, Faculte′ deMe′decine, Lille,France,4Eurogentec,ParcScientifique,Seraing,Belgium Abstract Background: Treatment of urinary schistosomiasis by chemotherapy remains challenging due to rapid re-infection and possibly to limited susceptibility to praziquantel treatment. Therefore, therapeutic vaccines represent an attractive alternativecontrolstrategy.Theobjectivesofthisstudyweretoassessthesafetyandtolerabilityprofileoftherecombinant 28kDa glutathione S-transferase of Schistosoma haematobium (rSh28GST) in healthy volunteers, and to determine its immunogenicity. Methodology: Volunteers randomly received 100mg rSh28GST together with aluminium hydroxide (Alum) as adjuvant (n=8),orAlumaloneasacomparator(n=8),twicewitha28-dayintervalbetweendoses.AthirddoseofrSh28GSTorAlum alonewasadministeredtothisgroupatday150.Inviewoftheresultsobtained,anothergroupofhealthyvolunteers(n=8) receivedtwodosesof300mgofrSh28GST,againwitha28-dayinterval.Asix-monthfollow-upwasperformedwithboth clinicalandbiologicalevaluations.Immunogenicityofthevaccinecandidatewasevaluatedintermsofspecificantibody production,thecapacityofseratoinhibitenzymaticactivityoftheantigen,andinvitrocytokineproduction. PrincipalFindings:Amongthe24healthymaleparticipantsnoseriousadverseeventswerereportedinthedaysorweeks afteradministration.FoursubjectsunderrSh28GSTreportedmildreactionsattheinjectionsitewhileaclinicallyinsignificant increaseinbilirubinwasobservedin8/24subjects.Nohematologicalnorbiochemicalevidenceoftoxicitywasdetected. Immun