Evaluation of the Intervention Effect of Appropriate Techniques for Myopia Prevention and Control (Traditional Chinese Medicine Auricular Point Pressing ) on Children and Adolescents with Pre myopia

开始日期2023-11-15

申办/合作机构

Jiangsu Provincial Center For Disease Control And Prevention

ChiCTR2300076253 / Suspended临床3期IIT

A Randomized, double-blind, placebo-controlled phase III clinical study to evaluate efficacy and safety of a recombinant herpes zoster vaccine (CHO) in subjects aged elder than 40 years inclusive

开始日期2023-09-28

申办/合作机构

Jiangsu Provincial Center For Disease Control And Prevention

100 项与 Jiangsu Provincial Center For Disease Control And Prevention 相关的临床结果

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0 项与 Jiangsu Provincial Center For Disease Control And Prevention 相关的专利（医药）

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1,701

项与 Jiangsu Provincial Center For Disease Control And Prevention 相关的文献（医药）

2024-12-31·Emerging Microbes & Infections

Relative effectiveness of a heterologous booster dose with adenovirus type 5 vectored COVID-19 vaccine versus three doses of inactivated COVID-19 vaccine in adults during a nationwide outbreak of omicron predominance, in China: a retrospective, individually matched cohort-control study

作者: Liu, Xiaoqiang ; Yang, Hao ; Jin, Pengfei ; Li, Simin ; Zhang, Li ; Yin, Zundong ; Tang, Rong ; Wang, Zhiguo ; Wang, Weixiao ; Zhu, Fengcai ; Peng, Zhihang ; Li, Jingxin ; Wang, Qing ; Wang, Xuewen ; Pan, Hongxing ; Kang, Guodong ; Jia, Siyue ; Shen, Hongbing ; Wang, Fuzhen ; Tang, Jihai ; Du, Jiangbo

Effectiveness of heterologous booster regimes with ad5 vectored COVID-19 vaccine in a large, diverse population during the national-scale outbreak of SARS-CoV-2 omicron predominance in China has not been reported, yet.We conducted a large-scale cohort-control study in six provinces in China, and did a retrospective survey on the COVID-19 attack risk during this outbreak.Participant aged ≥18 years in five previous trials who were primed with 1 to 3 doses of ICV received heterologous booster with either i.m. or orally inhaled ad5 vectored COVID-19 vaccine were included in the heterologous-trial cohort.We performed propensity score-matching at a ratio of 1:4 to match participants in the heterologous-trial cohort individually with the community individuals who received three-dose of ICV as a control (ICV-community cohort).From Feb. 4 to Apr. 10, 2023, 41504 (74.5%) of 55710 individuals completed the survey.The median time since the most recent vaccination to the onset of the symptoms of COVID-19 was 303.0 days (IQR 293.0-322.0).The attack rate of COVID-19 in the heterologous-trial cohort was 55.8%, while that in the ICV-community cohort was 64.6%, resulting in a relative effectiveness of 13.7% (95% CI 11.9 to 15.3).In addition, a higher relative effectiveness against COVID-19 associated outpatient visits, and admission to hospital was demonstrated, which was 25.1% (95% CI 18.9 to 30.9), and 48.9% (95% CI 27.0 to 64.2), resp.The heterologous booster with ad5 vectored COVID-19 vaccine still offered some addnl. protection in preventing COVID-19 breakthrough infection vs. homologous three-dose regimen with ICV, 10 mo after vaccination.

2024-12-31·Human Vaccines & Immunotherapeutics

The seroepidemiology of immunoglobulin G antibodies against pertussis toxin and filamentous hemagglutinin in the east of China during the COVID-19 pandemic

Article

作者: Sun, Xiang ; Zhou, Juan ; Wu, Yun ; Wang, Wen ; Zhang, Tingting ; Xu, Yan ; Sun, Jinning ; Chen, Qiang ; Jia, Chengmei ; Wang, Zhiguo

This study employed sero-epidemiological methods to estimate the incidence of pertussis within a healthy population located in eastern China. The aim was to gain deeper insights into the epidemiological characteristics and burden of pertussis within the country. Blood samples were collected from healthy individuals in Jiangsu Province between June 2019 and December 2022. The levels of IgG antibodies against pertussis toxin (anti-PT) and filamentous hemagglutinin (anti-FHA) in the serum were quantitatively measured using enzyme-linked immunosorbent assay (ELISA). Additionally, pertussis case data reported in Jiangsu Province were collected from the China Information System for Disease Control and Prevention and compared with the results of this study. In 2022, the reported incidence of pertussis stood at 1.0 per 100,000 individuals, marking the highest rate observed in the past two decades. Among 1,909 patients examined, the geometric mean concentration (GMC) of anti-PT IgG antibody was 20.2 (18.5-21.9) IU/ml, while that of anti-FHA IgG antibody was 27.0 (25.4-28.7) IU/ml. The IgG-PT and IgG-FHA seropositivity rate (>20.0 IU/ml) was highest in the 1 ~ 2 y old group and decreased rapidly to the lowest in the 3 ~ 4 y old group and then increased gradually with age. The estimated rate of pertussis infection based on seroprevalence was approximately 25,625-fold higher than the reported notification rate in the ≥15 year age group. Our findings highlight decreased immunity post-vaccination, stressing the importance of additional booster shots for adolescents and adults to maintain immunity and reduce severe illness. Additionally, they offer vital guidance for policymakers to enhance immunization strategies.

2024-12-31·Expert Review of Vaccines

Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies

Article

作者: Villalobos, Ralph Elvi ; Wang, Qing-Shuang ; Ma, Ying ; Tirador, Louie ; Wen, Ren-Du ; Chen, Wen-Li ; Liu, Yong ; Mo, Chen ; Yao, Zheng ; Hassan, Aala ; Hong, Kun-Xue ; Jaen, Anjuli May ; Yu, Jia-Ping ; Yue, Zi-Jing ; Balgos, Abundio ; Abuquta, Alaa ; Hannawi, Suad ; Yao, Wen-Rong ; Li, Jing-Xin ; Zhang, Jian-Hui ; Safeldin, Linda ; Alamadi, Ahmad

BACKGROUNDRecombinant protein vaccines are vital for broad protection against SARS-CoV-2 variants. This study assessed ReCOV as a booster in two Phase 2 trials.RESEARCH DESIGN AND METHODSStudy-1 involved subjects were randomized (1:1:1) to receive 20 μg ReCOV, 40 μg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates. Study-2 participating individuals were randomized (1:1:1) to receive 20 μg ReCOV (pilot batch, ReCOV HA), 20 μg ReCOV (commercial batch, ReCOV TC), or 30 μg BNT162b2 (COMIRNATY®) in the Philippines. The primary immunogenicity objectives was to compare the geometric mean titer (GMT) and seroconversion rate (SCR) of neutralizing antibodies induced by one ReCOV booster dose with those of inactivated vaccine and BNT162b2, respectively, at 14 days post-booster.RESULTSHeterologous ReCOV booster doses were safe and induced comparable immune responses to inactivated vaccines and BNT162b2 against Omicron variants and the prototype. They showed significant advantages in cross-neutralization against multiple SARS-CoV-2 variants, surpassing inactivated vaccines and BNT162b2, with good immune persistence.CONCLUSIONSHeterologous ReCOV boosting was safe and effective, showing promise in combating COVID-19. The study highlights ReCOV's potential for enhanced protection, supported by strong cross-neutralization and immune persistence.CLINICAL TRIAL REGISTRATIONStudy-1, www.clinicaltrials.gov, identifier is NCT05323435; Study-2, www.clinicaltrials.gov, identifier is NCT05084989.

项与 Jiangsu Provincial Center For Disease Control And Prevention 相关的新闻（医药）

2024-04-11

·Pharma CMC

万泰生物九价HPV疫苗III期临床试验揭盲！主要结果符合预期

4月11日，万泰生物发布关于公司九价HPV疫苗III期临床试验揭盲结果的公告。九价HPV疫苗III期临床试验采用了多中心、随机、双盲、二价HPV疫苗对照的设计，由江苏省疾病预防控制中心（江苏省公共卫生研究院）作为组长单位，在全国5个试验现场共同开展。本试验共设置12次访视（V1-V12访视），截至V8访视标本检测结束，主要分析数据集中已累积到方案预定的12月持续性感染终点事件数，随着数据清理、盲态数据审核会、数据库锁定及揭盲等工作的完成，近日公司收到了第三方统计公司交付的主要数据初步分析结果，主要结果符合预期。本次九价HPV疫苗III期临床试验揭盲获得的数据仅为截至V8访视的部分主要结果，后续还需根据方案及统计分析计划的规定开展全面深入分析，并完成临床试验总结报告。同时，万泰生物在公告中披露，公司正同步开展新药注册申请资料的撰写工作，并将积极开展与药监部门沟通申报事宜。九价HPV疫苗III期临床试验后续仍需按方案设计继续开展对CIN2+等组织病理学终点事件的监测，直至累积至方案预定的组织病理学终点事件数或完成全部12次访视工作。万泰生物的九价HPV疫苗基于公司前期二价HPV疫苗基础，覆盖HPV16/18/31/33/45/52/58七种高危型和HPV6/11两种低危型，其适应症为预防人乳头瘤病毒HPV6和HPV11感染及因此引发的尖锐湿疣等疾病和人乳头瘤病毒HPV16、HPV18、HPV31、HPV33、HPV45、HPV52、HPV58感染及因此引发的宫颈癌等疾病。国内已获批上市销售的九价HPV疫苗仅有默沙东公司的九价人乳头瘤病毒疫苗（酿酒酵母）。来源：万泰生物公告

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