{"id":21245,"date":"2022-03-12T05:30:00","date_gmt":"2022-03-11T21:30:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21245"},"modified":"2022-03-12T09:47:43","modified_gmt":"2022-03-12T01:47:43","slug":"lancet-infect-dis%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e7%81%ad%e6%b4%bb%e7%96%ab%e8%8b%97%e5%af%b918%e5%b2%81%e4%bb%a5%e4%b8%8b%e4%ba%ba%e7%be%a4","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21245","title":{"rendered":"[Lancet Infect Dis\u53d1\u8868\u8bba\u6587]\uff1a\u65b0\u51a0\u75c5\u6bd2\u706d\u6d3b\u75ab\u82d7\u5bf918\u5c81\u4ee5\u4e0b\u4eba\u7fa4\u7684\u5b89\u5168\u6027\u4e0e\u514d\u75ab\u539f\u6027"},"content":{"rendered":"\n

ARTICLES| VOLUME 22, ISSUE 2<\/a>, P196-208, FEBRUARY 01, 2022<\/p>\n\n\n\n

Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomised, double-blind, controlled, phase 1\/2 trial<\/h1>\n\n\n\n

ShengLi Xia, YunTao Zhang, YanXia Wang, et al<\/h3>\n\n\n\n

Lancet Infect Dis 2022; 22: 196-208<\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

Although SARS-CoV-2 infection often causes milder symptoms in children and adolescents, young people might still play a key part in SARS-CoV-2 transmission. An efficacious vaccine for children and adolescents could therefore assist pandemic control. For further evaluation of the inactivated COVID-19 vaccine candidate BBIBP-CorV, we assessed the safety and immunogenicity of BBIBP-CorV in participants aged 3\u201317 years.<\/p>\n\n\n\n

\u5c3d\u7ba1\u00a0SARS-CoV-2\u00a0\u611f\u67d3\u5728\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u4e2d\u901a\u5e38\u4f1a\u5f15\u8d77\u8f83\u8f7b\u7684\u75c7\u72b6\uff0c\u4f46 \u5e74\u8f7b\u4eba\u53ef\u80fd\u4ecd\u4f1a\u5728\u00a0SARS-CoV-2\u00a0\u4f20\u64ad\u4e2d\u53d1\u6325\u5173\u952e\u4f5c\u7528\u3002\u56e0\u6b64\uff0c\u4e00\u79cd\u6709 \u6548\u7684\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u75ab\u82d7\u53ef\u4ee5\u5e2e\u52a9\u63a7\u5236\u75be\u75c5\u6d41\u884c\u3002\u4e3a\u4e86\u8fdb\u4e00\u6b65\u8bc4\u4f30\u7684\u00a0COVID-19\u00a0\u706d\u6d3b\u75ab\u82d7\u00a0BBIBP-CorV\uff0c\u6211\u4eec\u5728\u00a03~17\u00a0\u5c81\u53c2\u4e0e\u8005\u4e2d\u8bc4\u4f30\u4e86BBIBP-CorV\u00a0\u7684\u5b89\u5168\u6027\u548c\u514d\u75ab\u539f\u6027\u3002<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

A randomised, double-blind, controlled, phase 1\/2 trial was done at Shangqiu City Liangyuan District Center for Disease Control and Prevention in Henan, China. In phases 1 and 2, healthy participants were stratified according to age (3\u20135 years, 6\u201312 years, or 13\u201317 years) and dose group. Individuals with a history of SARS-CoV-2 or SARS-CoV infection were excluded. All participants were randomly assigned, using stratified block randomisation (block size eight), to receive three doses of 2 \u03bcg, 4 \u03bcg, or 8 \u03bcg of vaccine or control (1:1:1:1) 28 days apart. The primary outcome, safety, was analysed in the safety set, which consisted of participants who had received at least one vaccination after being randomly assigned, and had any safety evaluation information. The secondary outcomes were geometric meant titre (GMT) of the neutralising antibody against infectious SARS-CoV-2 and were analysed based on the full analysis set. This study is registered with\u00a0www.chictr.org.cn<\/a>, ChiCTR2000032459, and is ongoing.<\/p>\n\n\n\n

\u5728\u4e2d\u56fd\u6cb3\u5357\u7701\u5546\u4e18\u5e02\u6881\u56ed\u533a\u75be\u75c5\u9884\u9632\u63a7\u5236\u4e2d\u5fc3\u8fdb\u884c\u4e86\u4e00\u9879\u968f\u673a\u3001\u53cc\u76f2\u3001 \u5bf9\u7167\u7684I\/II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5065\u5eb7\u53c2\u4e0e\u8005\u6839\u636e\u5e74\u9f84(3~5\u00a0\u5c81\u30016~12\u00a0\u5c81\u6216\u00a013~17\u00a0\u5c81)\u548c\u5242\u91cf\u7ec4\u8fdb\u884c\u5206\u5c42\u3002\u6709\u00a0SARS-CoV-2\u00a0\u6216\u00a0SARS-CoV\u00a0\u611f\u67d3\u53f2 \u7684\u4e2a\u4f53\u88ab\u6392\u9664\u5728\u5916\u3002\u6240\u6709\u53c2\u4e0e\u8005\u90fd\u4f7f\u7528\u5206\u5c42\u533a\u7ec4\u968f\u673a\u5316(\u533a\u7ec4\u5927\u5c0f \u4e3a\u00a08)\u968f\u673a\u5206\u914d\u63a5\u53d7\u4e09\u5242\u00a02\/4\/8 \u03bcg\u00a0\u75ab\u82d7\u6216\u5bf9\u7167(\u6bd4\u4f8b\u4e3a\u00a01:1:1:1)\uff0c\u6bcf\u5242\u95f4 \u9694\u00a028\u00a0\u5929\u3002\u4e3b\u8981\u7ec8\u70b9\u662f\u57fa\u4e8e\u5b89\u5168\u6027\u6570\u636e\u96c6\u5206\u6790\u7684\u5b89\u5168\u6027\uff0c\u8be5\u6570\u636e\u96c6\u7531 \u968f\u673a\u5206\u914d\u540e\u81f3\u5c11\u63a5\u53d7\u8fc7\u4e00\u6b21\u75ab\u82d7\u63a5\u79cd\u5e76\u5177\u6709\u4efb\u4f55\u5b89\u5168\u6027\u8bc4\u4f30\u4fe1\u606f\u7684 \u53c2\u4e0e\u8005\u7ec4\u6210\u3002\u6b21\u8981\u7ec8\u70b9\u662f\u9488\u5bf9\u00a0SARS-CoV-2\u00a0\u6d3b\u75c5\u6bd2\u7684\u4e2d\u548c\u6297\u4f53\u7684\u51e0\u4f55 \u5e73\u5747\u6ef4\u5ea6\u00a0(GMT)\u3002\u8fd9\u9879\u7814\u7a76\u4ecd\u5728\u8fdb\u884c\u4e2d\uff0c\u5e76\u5728\u00a0www.chictr.org.cn\u00a0\u6ce8 \u518c\uff0c\u6ce8\u518c\u53f7\u00a0ChiCTR2000032459\u3002<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

Between Aug 14, 2020, and Sept 24, 2020, 445 participants were screened, and 288 eligible participants were randomly assigned to vaccine (n=216, 24 for each dose level [2\/4\/8 \u03bcg] in each of three age cohorts [3\u20135, 6\u201312, and 13\u201317 years]) or control (n=72, 24 for each age cohort [3\u20135, 6\u201312, and 13\u201317 years]) in phase 1. In phase 2, 810 participants were screened and 720 eligible participants were randomly assigned and allocated to vaccine (n=540, 60 for each dose level [2\/4\/8 \u03bcg] in each of three age cohorts [3\u20135, 6\u201312, and 13\u201317 years]) or control (n=180, 60 for each age cohort [3\u20135, 6\u201312, and 13\u201317 years]). The most common injection site adverse reaction was pain (ten [4%] 251 participants in all vaccination groups of the 3\u20135 years cohort; 23 [9\u00b71%] of 252 participants in all vaccination groups and one [1\u00b72%] of 84 in the control group of the 6\u201312 years cohort; 20 [7\u00b79%] of 252 participants in all vaccination groups of the 13\u201317 years cohort). The most common systematic adverse reaction was fever (32 [12\u00b77%] of 251 participants in all vaccination groups and six [7\u00b71%] of 84 participants in the control group of the 3\u20135 years cohort; 13 [5\u00b72%] of 252 participants in the vaccination groups and one [1\u00b72%] of 84 in the control group of the 6\u201312 years cohort; 26 [10\u00b73%] of 252 participants in all vaccination groups and eight [9\u00b75%] of 84 in the control group of the 13\u201317 years cohort). Adverse reactions were mostly mild to moderate in severity. The neutralising antibody GMT against the SARS-CoV-2 virus ranged from 105\u00b73 to 180\u00b72 in the 3\u20135 years cohort, 84\u00b71 to 168\u00b76 in the 6\u201312 years cohort, and 88\u00b70 to 155\u00b77 in the 13\u201317 years cohort on day 28 after the second vaccination; and ranged from 143\u00b75 to 224\u00b74 in the 3\u20135 years cohort, 127 to 184\u00b78 in the 6\u201312 years cohort, and 150\u00b77 to 199 in the 13\u201317 years cohort on day 28 after the third vaccination.<\/p>\n\n\n\n

\u57282020\u5e748\u670814\u65e5\u81f32020\u5e749\u670824\u65e5\uff0cI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5bf9445\u540d\u53c2 \u4e0e\u8005\u8fdb\u884c\u4e86\u7b5b\u67e5\uff0c288\u00a0\u540d\u5408\u683c\u7684\u53d7\u8bd5\u8005\u88ab\u968f\u673a\u5206\u914d\u5230\u75ab\u82d7\u7ec4(n=216\uff0c
3 ~ 5\u00a0\u30016 ~ 1 2\u00a0\u548c\u00a01 3 ~ 1 7\u00a0\u5c81 \u5e74 \u9f84 \u7ec4 \u7684\u00a02 \/ 4 \/ 8 \u03bc g\u00a0\u6bcf \u5242 \u91cf \u7ec4\u00a02 4\u00a0\u4eba )\u6216 \u5bf9 \u7167(\u00a0n = 7 2\u00a0\uff0c3~5\u30016~12\u00a0\u548c\u00a013~17\u00a0\u5c81\u4e09\u4e2a\u5e74\u9f84\u7ec4\u5404\u00a024\u00a0\u4eba)\u3002II\u671f\u4e34\u5e8a\u8bd5\u9a8c\u5bf9\u00a0810\u00a0\u540d \u53c2\u4e0e\u8005\u8fdb\u884c\u4e86\u7b5b\u67e5\uff0c720\u00a0\u540d\u5408\u683c\u7684\u53c2\u4e0e\u8005\u88ab\u968f\u673a\u5206\u914d\u5e76\u5206\u914d\u5230\u75ab\u82d7\u7ec4 (n=540\uff0c3~5\u30016~12\u00a0\u548c\u00a013~17\u00a0\u5c81\u5e74\u9f84\u7ec4\u7684\u00a02\/4\/8\u03bcg\u00a0\u6bcf\u4e2a\u5242\u91cf\u7ec4\u00a060\u00a0\u4eba)\u00a0\u6216\u5bf9\u7167(n=180\uff0c3~5\u30016~12\u00a0\u548c\u00a013~17\u00a0\u5c81\u6bcf\u4e2a\u5e74\u9f84\u7ec4\u00a060\u00a0\u4eba)\u3002\u6700\u5e38\u89c1\u7684\u6ce8\u5c04\u90e8\u4f4d\u4e0d\u826f\u53cd\u5e94\u662f\u75bc\u75db[3~5\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0251\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a010\u00a0\u4eba (4%);\u00a06~12\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0252\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a023\u00a0\u4eba(9\u00b71%)\u548c\u5bf9\u7167\u7ec4\u00a084\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u00a01\u00a0\u4eba(1\u00b72%);13~17\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0252\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a020\u00a0\u4eba(7\u00b79%)]\u3002\u6700\u5e38\u89c1\u7684\u5168\u8eab\u4e0d\u826f\u53cd\u5e94\u662f\u53d1\u70ed[3~5\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0251\u00a0\u540d\u53d7 \u8bd5\u8005\u4e2d\u6709\u00a032\u00a0\u4eba(12.7%)\uff0c\u5bf9\u7167\u7ec4\u00a084\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a06\u00a0\u4eba(7.1%);6~12\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0252\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a013\u00a0\u4eba(5.2%)\uff0c\u5bf9\u7167\u7ec4\u00a084\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u7684\u00a01\u00a0\u4eba(1\u00b72%);13~17\u00a0\u5c81\u75ab\u82d7\u7ec4\u00a0252\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a026\u00a0\u4eba(10.3%)\uff0c\u5bf9 \u7167\u7ec4\u7684\u00a084\u00a0\u540d\u53d7\u8bd5\u8005\u4e2d\u6709\u00a08\u00a0\u4eba(9\u00b75%)]\u3002\u4e0d\u826f\u53cd\u5e94\u7684\u4e25\u91cd\u7a0b\u5ea6\u591a\u4e3a\u8f7b \u5ea6\u81f3\u4e2d\u5ea6\u3002\u5728\u7b2c\u4e8c\u5242\u63a5\u79cd\u540e\u00a028\u00a0\u5929\uff0c\u9488\u5bf9\u00a0SARS-CoV-2\u00a0\u6d3b\u75c5\u6bd2\u7684\u4e2d\u548c \u6297\u4f53\u00a0GMT\u00a0\u5728\u00a03~5\u00a0\u5c81\u7ec4\u4e3a\u00a0105.3~180.2\uff0c\u5728\u00a06~12\u00a0\u5c81\u7ec4\u4e3a\u00a084.1~168.6\uff0c\u00a013~17\u00a0\u5c81\u7ec4\u4e3a\u00a088.0~155.7;\u5728\u7b2c\u4e09\u5242\u63a5\u79cd\u540e\u00a028\u00a0\u5929\uff0c\u5728\u00a03~5\u00a0\u5c81\u7ec4\u4e3a\u00a0143.5~224.4\uff0c\u5728\u00a06~12\u00a0\u5c81\u7ec4\u4e3a\u00a0127~184.8\uff0c\u5728\u00a013~17\u00a0\u7ec4\u4e3a\u00a0150.7 ~199\u3002<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n
\"\"\/<\/figure>\n\n\n\n

Interpretation<\/h3>\n\n\n\n

The inactivated COVID-19 vaccine BBIBP-CorV is safe and well tolerated at all tested dose levels in participants aged 3\u201317 years. BBIBP-CorV also elicited robust humoral responses against SARS-CoV-2 infection after two doses. Our findings support the use of a 4 \u03bcg dose and two-shot regimen BBIBP-CorV in phase 3 trials in the population younger than 18 years to further ascertain its safety and protection efficacy against COVID-19.<\/p>\n\n\n\n

COVID-19\u00a0\u706d\u6d3b\u75ab\u82d7\u00a0BBIBP-CorV\u00a0\u5728\u00a03-17\u00a0\u5c81\u53c2\u4e0e\u8005\u7684\u6240\u6709\u6d4b\u8bd5\u5242\u91cf \u6c34\u5e73\u4e0b\u90fd\u662f\u5b89\u5168\u4e14\u8010\u53d7\u6027\u826f\u597d\u7684\u3002\u5728\u63a5\u79cd\u4e24\u5242\u00a0BBIBP-CorV\u00a0\u540e\u53ef\u5f15\u53d1 \u9488\u5bf9\u00a0SARS-CoV-2\u00a0\u7684\u5f3a\u70c8\u4f53\u6db2\u514d\u75ab\u53cd\u5e94\u3002\u6211\u4eec\u7684\u7814\u7a76\u7ed3\u679c\u652f\u6301\u4f7f\u7528\u00a04\u03bcg\u00a0\u5242\u91cf\u00a0BBIBP-CorV\uff0c\u4e24\u6b21\u514d\u75ab\u65b9\u6848\uff0c\u5728\u00a018\u00a0\u5c81\u4ee5\u4e0b\u4eba\u7fa4\u5f00\u5c55\u00a03\u00a0\u671f\u4e34 \u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u8fdb\u4e00\u6b65\u786e\u5b9a\u5176\u5bf9\u00a0COVID-19\u00a0\u7684\u5b89\u5168\u6027\u548c\u4fdd\u62a4\u6548\u529b\u3002<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

National Program on Key Research Project of China, National Mega projects of China for Major Infectious Diseases, National Mega Projects of China for New Drug Creation, and Beijing Science and Technology Plan.<\/p>\n\n\n\n

Translation<\/h3>\n\n\n\n

For the Chinese translation of the abstract see Supplementary Materials section.<\/p>\n","protected":false},"excerpt":{"rendered":"

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