伤寒结合疫苗可有效降低尼泊尔儿童伤寒发病率
2019-12-11   阅读:385   来源:NEJM

伤寒结合疫苗可有效降低尼泊尔儿童伤寒发病率,这一成果由英国丘吉尔医院MerrynVoysey研究组取得。该项研究成果发表在2019年12月5日的《新英格兰医学杂志》上。

伤寒沙门菌是中低收入国家儿童发热的主要原因。最近通过世界卫生组织资格预审的伤寒结合疫苗(TCV)在人类挑战模型中被证明有效,但在伤寒流行地区的疗效仍有待观察。

研究组在尼泊尔拉利特布尔进行了一项临床3期、双盲、随机对照的试验,招募9个月至16岁的儿童,按1:1随机分组,其中10005名儿童接受TCV,10014名接受A群脑膜炎球菌结合疫苗(MenA,对照组)。

TCV组中有7名儿童经血液培养确诊为伤寒,发病率为每10万人年79例,对照组中有38名,发病率为每10万人年428例,疫苗效力为81.6%。接种6个月内共发生严重不良事件132例,其中TCV组61例,对照组71例,1例被认为与疫苗有关。

两组间不良事件发生率相似,TCV组有5.0%的儿童接种1周内出现发热,对照组为5.4%。在免疫原性亚组中,TCV组的血清转化率(Vi-lgG接种28天后至少增加4倍)为99%,而对照组为2%。

总之,单剂量TCV具有免疫原性,可有效降低9个月至16岁儿童伤寒杆菌血症的发病率。

附:英文原文

Title:Phase3EfficacyAnalysisofaTyphoidConjugateVaccineTrialinNepal

Author:MilaShakya,M.P.H.,,RachelColin-Jones,M.A.,,KatherineTheiss-Nyland,Ph.D.,,MerrynVoysey,D.Phil.,,DikshyaPant,F.C.P.S.,,NicolaSmith,M.B.,B.Chir.,,XinxueLiu,Ph.D.,,SusanTonks,B.Sc.,,OlgaMazur,B.Sc.,,YamaG.Farooq,M.Sc.,,JennyClarke,Ph.D.,,JenniferHill,Ph.D.,,AnupAdhikari,M.A.,,SabinaDongol,D.Phil.,,AbhilashaKarkey,D.Phil.,,BinodBajracharya,M.D.,,SarahKelly,M.Sc.,,MeeruGurung,M.D.,,StephenBaker,Ph.D.,,KathleenM.Neuzil,M.D.,,ShrijanaShrestha,M.D.,,BuddhaBasnyat,F.R.C.P.E.,,andAndrewJ.Pollard,F.Med.Sci.

Issue&Volume:2019-12-04

Abstract:

Background

SalmonellaTyphiisamajorcauseoffeverinchildreninlow-andmiddle-incomecountries.Atyphoidconjugatevaccine(TCV)thatwasrecentlyprequalifiedbytheWorldHealthOrganizationwasshowntobeefficaciousinahumanchallengemodel,butdatafromefficacytrialsinareaswheretyphoidisendemicarelacking.

Methods

Inthisphase3,randomized,controlledtrialinLalitpur,Nepal,inwhichboththeparticipantsandobserverswereunawareofthetrial-groupassignments,werandomlyassignedchildrenwhowerebetween9monthsand16yearsofage,ina1:1ratio,toreceiveeitheraTCVoracapsulargroupAmeningococcalconjugatevaccine(MenA)asacontrol.Theprimaryoutcomewastyphoidfeverconfirmedbybloodculture.Wepresenttheprespecifiedanalysisoftheprimaryandmainsecondaryoutcomes(includinganimmunogenicitysubgroup);the2-yeartrialfollow-upisongoing.

Results

Atotalof10,005participantsreceivedtheTCVand10,014receivedtheMenAvaccine.Bloodculture–confirmedtyphoidfeveroccurredin7participantswhoreceivedTCV(79casesper100,000person-years)andin38whoreceivedMenAvaccine(428casesper100,000person-years)(vaccineefficacy,81.6%;95%confidenceinterval,58.8to91.8;P<0.001).Atotalof132seriousadverseevents(61intheTCVgroupand71intheMenAvaccinegroup)occurredinthefirst6months,and1event(pyrexia)wasidentifiedasbeingvaccine-related;theparticipantremainedunawareofthetrial-groupassignment.Similarratesofadverseeventswerenotedinthetwotrialgroups;feverdevelopedin5.0%ofparticipantsintheTCVgroupand5.4%intheMenAvaccinegroupinthefirstweekaftervaccination.Intheimmunogenicitysubgroup,seroconversion(aViIgGlevelthatatleastquadrupled28daysaftervaccination)was99%intheTCVgroup(677of683participants)and2%intheMenAvaccinegroup(8of380participants).

Conclusions

AsingledoseofTCVwasimmunogenicandeffectiveinreducingS.Typhibacteremiainchildren9monthsto16yearsofage.

DOI:10.1056/NEJMoa1905047

#疫苗 #儿童伤寒
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