葛兰素史克埃博拉疫苗成功通过II期安全性试验

2015年3月30日讯/生物谷BIOON/--目前，英国制药巨头葛兰素史克（GSK）与NewLinkGenetics公司正在埃博拉重灾区利比亚（LIberia）开展中期临床试验。近日美国国立卫生研究院（NIH）发布最新消息，根据对中期临床试验初步数据的审查，2家公司研发的2种实验性埃博拉疫苗具有良好的安全性。
这些试验由NIH下属机构国家过敏和传染病研究所（NIAID）赞助，于今年2月2日在利比里亚（Liberia）首都蒙罗维亚市(Monrovia)开展，计划在超过60名健康志愿者中调查疫苗的安全性和有效性。
过去的一年里，这场在西非肆虐的史无前例的埃博拉疫情，已导致1.02万人丧生。其中受灾最为严重的国家为利比里亚、塞拉利昂、几内亚。不过，最近这些国家中新的病例已经减少，为埃博拉疫情的结束带来了新的希望。
根据临床试验的安排，健康受试者随机注射葛兰素史克的疫苗、NewLink的疫苗、生理盐水。随后，研究人员将评估受试者体内埃博拉抗体的水平。
NIAID主任AnthonyFauci在声明中对利比里亚的临床志愿者表示了由衷的感谢，同时强调必须继续调整和扩大研究，以便最终能确定这些实验性疫苗是否能预防埃博拉病毒感染，从而应用于未来可能爆发的埃博拉疫情。
此次公布的安全性数据，只是该项临床研究的一部分，这些数据将推动这2种埃博拉疫苗进入下一阶段的有效性试验。研究人员计划在4月份招募约1500名健康受试者，届时将在疫苗免疫后的6周和12周采集血液样本，评估免疫反应随时间推移的变化。
英文原文：GlaxoSmithKlineplc(ADR)AndNewLinkGeneticsCorp,EbolaVaccinesClearSafetyTestsInLiberia
GlaxoSmithKlineandNewLinkGeneticssawtheirEbolavaccinesclearsafetybenchmarksintheongoingmid-stageclinicaltrialsinLiberia
TheUSNationalInstitutesofHealth(NIH)saidthattwoexperimentalEbolavaccines,onefromGlaxoSmithKlineplc(ADR)(NYSE:GSK)andanotherfromNewLinkGeneticsCorp(NASDAQ:NLNK),“appeartobesafe,”aspertheinitialdatareviewofmid-stageclinicaltrialscurrentlyunderwayinLiberia.
TheNationalInstituteofAllergyandInfectiousDiseases(NIAID),abranchofNIH,issponsoringthetrialsforthetwovaccines.Thesetrialsaimtotestandcomparethesafetyandefficacyofthetwosingle-injectionvaccinesonmorethan60healthyLiberianvolunteers.ThestudiesstartedonFebruary2inMonrovia,Liberia.
Ebolavirusdiseaseisanoftenlethalvirus,contractedfromwildanimalsandotherinfectedhumans.Theaveragefatalityrateforthoseimpactedisnearly50%.Currently,thereexistnolicensedvaccinesinthemarket.
TheepidemicstartedinWestAfricaoverayearagoandhasresultedinmorethan10,200deathssincethen.
EbolahasaffectedLiberia,Guinea,andSierraLeonethemost,althougharecentreductioninnewreportedcasesfromthesecountrieshassparkedhopesthattheepidemicmaybenearingitsend.
ThetrialsubjectswererandomlyinjectedwiththeGSKvaccine,theNewLinkvaccine,andasalineshot.Thetrialvolunteersandresearchersremainedcompletelyunawareofwhichsubjecthadreceivedwhichinjection.Theresultswerethenevaluatedonthebasisofthesubjects’immunesystemresponsetotheinjectionintheformofanti-Ebolaantibodyproduction.
Noneofthevolunteersweredeliberatelyexposedtothehighlylife-threateningvirus.Onlytheirimmunesystem’sresponsestothevaccinesweremonitoredinthetrials.
Dr.AnthonyFauci,directorofNIAID,whilethankingtheLiberiantrialvolunteers,wentontosayinastatement:"NowwemustmoveforwardtoadaptandexpandthestudysothatultimatelywecandeterminewhethertheseexperimentalvaccinescanprotectagainstEbolavirusdiseaseandthereforebeusedinfutureEbolaoutbreaks."
Thepositiveresults,revealedonlypart-waythroughthestudy,giveago-aheadtothenextstageofefficiencytrialsforthetwovaccines,whichwouldbeconductedinadditionaltrialsubjects.Theresearchersintendtoenrollaround1,500trialvolunteersbyApril.Theyarespecificallyaimingtoenrollmorewomen,sincetheycomprised16%ofthefirstvolunteergroup.Thiswouldmakesurethestudyresultsremainfreefromanygender-basedvariances.
Thestudyisexpectedtoinvolvecontinuousmonitoringofthevolunteers.Bloodsampleswillbecollectedandtestedaftersixandtwelveweeksofvaccinationtoevaluatetheimmuneresponseovertime.
TheGSKvaccinewasdevelopedinassociationwiththeNIAIDresearchers,whiletheNewLinkvaccinewasdesignedbythePublicHealthAgencyofCanadaandlaterlicensedtoNewLink.
医药网新闻