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首个国产二价HPV疫苗3期临床结果发布:100%预防宫颈癌前病变

2022-08-30 厦门大学生命科学学院 网络

该疫苗安全性良好,在整个研究期间未发生与疫苗接种相关的严重不良事件,未发生与疫苗接种相关的妊娠结局和新生儿健康状况的异常。

宫颈癌是15-44岁女性第二大常见恶性肿瘤。据估计,我国每年约有10.9万新发宫颈癌病例,导致约5.9万人死亡。高危型人乳头瘤病毒(Human Papillomavirus,HPV)持续感染是女性宫颈癌的主要原因,其中以HPV 16型和18型危害最大,导致约70%的宫颈癌。2020年世界卫生组织发布《加速消除宫颈癌全球战略》,提出2030年前实现“15岁以下女孩接种HPV疫苗的覆盖率达到90%以上”的目标。在过去很长一段时间里,全球仅有3种预防性HPV疫苗获批使用,其价格高昂和产能不足极大阻碍了HPV疫苗的推广应用。夏宁邵教授团队与万泰生物联合研发的首个国产双价HPV疫苗馨可宁 ®于2019年12月在中国上市,获批9-14岁两剂次以及15-45岁女性中的三剂次免疫程序, 2021年通过世界卫生组织PQ认证并于2022年分别在摩洛哥和尼泊尔获批上市,为中国及全球的宫颈癌防控贡献中国力量。

研究团队基于全国5个现场开展多中心、随机、双盲、对照(戊肝疫苗益可宁 ®)的馨可宁 ®III期临床试验,对7372名18-45岁健康志愿者(试验组3689人、对照组3683人)进行66个月的随访。2019年,该研究42月随访的期中分析结果已在JNCI: Journal of the National Cancer Institute杂志发表,数据表明该疫苗在符合方案集(PPS)人群中,对HPV 16型和/或18型感染相关的病变终点(CIN2+和/或VIN2+和/或VaIN2+,高度宫颈、阴道和外阴癌前病变)的保护率为100.0%,对HPV 16型和/或18型持续性感染(6月以上)的保护率为97.8%,随着馨可宁 ®的推广应用,它的长期有效性,安全性为人们所关注。

对于馨可宁 ®III期临床试验66个月随访的终期分析结果显示,在符合方案集(PPS)人群中,该疫苗对HPV 16型和/或18型感染相关的病变终点(CIN2+和/或VIN2+和/或VaIN2+)的保护率为100.0%(95%置信区间:67.2%-100.0%),在18-26岁和27-45岁年龄组间保护效力分别为100.0%(95%置信区间:40.6%-100.0%)和100.0%(95%置信区间:-7.7%-100.0%)。对HPV 16型和/或18型持续性感染(6月以上)的保护率为97.3%(95%置信区间:89.9%-99.7%),在18-26岁和27-45岁年龄组间保护效力分别为93.9%(95%置信区间:76.3%-99.3%)和100.0%(95%置信区间:90.6%-100.0%)。该疫苗安全性良好,在整个研究期间未发生与疫苗接种相关的严重不良事件,未发生与疫苗接种相关的妊娠结局和新生儿健康状况的异常。该疫苗可有效诱导受试者产生较高水平的HPV 16型和18型中和抗体和IgG抗体并持续至少66个月。该研究结果证实馨可宁 ®在27-45岁及18-26岁易感女性人群中均具有优异的有效性以及良好的安全性,可有效地预防HPV 16型和/或18型相关的宫颈高度癌前病变及持续性感染。近日,研究成果以题为“Efficacy, Safety, and Immunogenicity of an Escherichia coli-Produced Human Papillomavirus (types 16 and 18) L1 Virus-like-particle Vaccine: end-of-study analysis of a phase 3 double-blind, randomized controlled trial”的论文在线发表于The Lancet Infectious Diseases。中国医学科学院肿瘤医院赵方辉教授、国家传染病诊断试剂与疫苗工程技术研究中心吴婷教授、江苏省疾病预防控制中心胡月梅主任医师、北京大学人民医院魏丽惠教授、柳州市疾病预防控制中心黎明强主任医师、中国食品药品检定研究院黄维金研究员、中国医学科学院肿瘤医院陈汶教授、国家传染病诊断试剂与疫苗工程技术研究中心黄守杰教授级高级工程师为该论文的共同第一作者,国家传染病诊断试剂与疫苗工程技术研究中心夏宁邵教授、中国医学科学院群医学与公共卫生学院乔友林教授和国家传染病诊断试剂与疫苗工程技术研究中心张军教授为该论文的共同通讯作者。该研究获得了国家自然科学基金、国家重点研发计划、福建省卫生教育联合攻关计划、福建省自然科学基金、中央高校研发基金、中国医学科学院创新单元以及厦门万泰沧海生物技术有限公司的资助。

论文链接:https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(22)00435-2/fulltext

(图/文 国家传染病诊断试剂与疫苗工程技术研究中心)

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    2022-09-01 一闲
  5. [GetPortalCommentsPageByObjectIdResponse(id=1715812, encodeId=f8b91e15812f1, content=<a href='/topic/show?id=6f9f4631036' target=_blank style='color:#2F92EE;'>#宫颈癌前病变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46310, encryptionId=6f9f4631036, topicName=宫颈癌前病变)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Sat Jan 21 02:30:06 CST 2023, time=2023-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898905, encodeId=5f331898905d1, content=<a href='/topic/show?id=729322969b9' target=_blank style='color:#2F92EE;'>#临床结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22969, encryptionId=729322969b9, topicName=临床结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4fd6156, createdName=oliver169, createdTime=Thu Dec 22 02:30:06 CST 2022, time=2022-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911300, encodeId=cce7191130041, content=<a href='/topic/show?id=18171289d6' target=_blank style='color:#2F92EE;'>#3期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1289, encryptionId=18171289d6, topicName=3期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d275294, createdName=andy2087, createdTime=Thu Dec 29 14:30:06 CST 2022, time=2022-12-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1408356, encodeId=946014083562c, content=<a href='/topic/show?id=92194628826' target=_blank style='color:#2F92EE;'>#宫颈#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46288, encryptionId=92194628826, topicName=宫颈)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11102737131, createdName=一闲, createdTime=Thu Sep 01 06:30:06 CST 2022, time=2022-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1242127, encodeId=1e8b124212e0e, content=任重道远, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a3618297653, createdName=ms9000001989367267, createdTime=Tue Aug 30 21:31:27 CST 2022, time=2022-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1242122, encodeId=aeb01242122ea, content=2030年前实现“15岁以下女孩接种HPV疫苗的覆盖率达到90%以上”的目标。, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d3a31581237, createdName=zwddoctor, createdTime=Tue Aug 30 21:09:53 CST 2022, time=2022-08-30, status=1, ipAttribution=)]
    2022-08-30 ms9000001989367267

    任重道远

    0

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    2022-08-30 zwddoctor

    2030年前实现“15岁以下女孩接种HPV疫苗的覆盖率达到90%以上”的目标。

    0

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