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Immunogenicity and Safety of Homologous Booster Doses of CoronaVac COVID-19 Vaccine in Elderly Individuals Aged 60 Years and Older:A Dosing Interval Study—Yunnan Province,China,2021–2022

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China CDC weekly 2023年第6期5卷 125-130,I0008-I0012页

作者： Haitao Yang Xing Meng Tingyu Zhuang Cangning Wang Zhongliang Yang Taotao Zhu Mei Li Yan Zheng Qianhui Wu Yaling Hu Hongjie Yu Xiaoqiang Liu Gang Zeng Yunnan Provincial Center for Disease Control and Prevention Kunming CityYunnan ProvinceChina sinovac biotech Co. Ltd.Beijing MunicipalityChina School of Public Health Fudan UniversityKey Laboratory of Public Health SafetyMinistry of EducationShanghai MunicipalityChina Yongde County Center for Disease Control and Prevention Lincang CityYunnan ProvinceChina sinovac Life Sciences Beijing MunicipalityChina

Summary What is already known about this topic?Neutralization levels induced by inactivated vaccines rapidly wane after primary immunization,and a homologous booster can recall specific immune memory,resulting in a remarkable increase in antibody concentration.The optimal interval between primary and booster doses has yet to be determined.

关键词： concentration. doses remarkable

A third high dose of inactivated COVID-19 vaccine induces higher neutralizing antibodies in humans against the Delta and Omicron variants:a Randomized,Double-Blinded Clinical Trial

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Science China(Life Sciences) 2022年第8期65卷 1677-1679页

作者： Yu Cao Xiaoli Wang Siqi Li Yuan Dong Yonghong Liu Jing Li Yanqing Zhao Yingmei Feng Department of Science and Technology Beijing Youan HospitalCapital Medical UniversityBeijing 100069China Beijing Center for Disease Prevention and Control Beijing 100013China sinovac biotech Co LtdBeijingBeijing 100085China

Dear Editor,The current pandemic of coronavirus disease 2019(COVID-19),caused by infection with severe acute respiratory syndrome coronavirus-2(SARS-Co V-2),has been ongoing for over 2 years.Like other viruses,SARS-Co... 详细信息

关键词： acute respiratory antibodies

Neutralizing Antibody Responses against Five SARS-CoV-2 Variants and T Lymphocyte Change after Vaccine Breakthrough Infections from the SARS-CoV-2 Omicron BA.1 Variant in Tianjin, China: A Prospective Study

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Biomedical and Environmental Sciences 2023年第7期36卷 614-624页

作者： ZHANG Ying QU Jiang Wen ZHENG Min Na DING Ya Xing CHEN Wei YE Shao Dong LI Xiao Yan LI Yan Kun LIU Ying ZHU Di JIN Can Rui WANG LIN YANG Jin Ye ZHAI Yu WANG Er Qiang MENG Xing Tianjin Center for Disease Control and Prevention Tianjin 300011China Tianjin Key Laboratory of Pathogenic Microbiology of Infectious Disease Tianjin 300011China National Center for AIDS/STD Control and Prevention Chinese Center for Disease Control and PreventionBeijing 102206China sinovac biotech Ltd Beijing 100085China

Objective To investigate whether Omicron BA.1 breakthrough infection after receiving the SARS-CoV-2 vaccine could create a strong immunity barrier.Methods Blood samples were collected at two different time points from 124 Omicron BA.1 breakthrough infected patients and 124 controls matched for age,gender,and vaccination profile.Live virus-neutralizing antibodies against five SARS-CoV-2 variants,including WT,Gamma,Beta,Delta,and Omicron BA.1,and T-lymphocyte lymphocyte counts in both groups were measured and statistically analyzed.Results The neutralizing antibody titers against five different variants of SARS-CoV-2 were significantly increased in the vaccinated population infected with the Omicron BA.1 variant at 3 months after infection,but mainly increased the antibody level against the WT strain,and the antibody against the Omicron strain was the lowest.The neutralizing antibody level decreased rapidly 6 months after infection.The T-lymphocyte cell counts of patients with mild and moderate disease recovered at 3 months and completely returned to the normal state at 6 months.Conclusion Omicron BA.1 breakthrough infection mainly evoked humoral immune memory in the original strain after vaccination and hardly produced neutralizing antibodies specific to Omicron BA.1.Neutralizing antibodies against the different strains declined rapidly and showed features similar to those of influenza.Thus,T-lymphocytes may play an important role in recovery.

关键词： SARS-CoV-2 COVID-19 Omicron BA.1 T cells Neutralizing antibodies

Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept

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Signal Transduction and Targeted Therapy 2023年第5期8卷 2078-2080页

作者： Jianyang Liu Yu Bai Mingchen Liu Dejiang Tan Jing Li Zhongfang Wang Zhenglun Liang Miao Xu Junzhi Wang Qunying Mao National Institutes for Food and Drug Control BeijingChina NHC Key Laboratory of Research on Quality and Standardization of biotech Products BeijingChina NMPA Key Laboratory for Quality Research and Evaluation of Biological Products BeijingChina sinovac Life Science Co. Ltd.BeijingChina Guangzhou Laboratory GuangzhouGuangdong ProvinceChina

Dear Editor,Vaccination is an effective strategy for controlling the COVID-19 pandemic and reducing the number of cases of hospitalization and deaths.1 Neutralizing antibody(Ntab)is one of the key indicators for evaluating the effectiveness of COVID-19 vaccines.2 Over 40 COVID-19 vaccines have been approved for emergency use,marketing,or marketing with conditions,and the available Ntab data from clinical trials have been published.

关键词： clinical QbD cases

Intranasal Immunization Using CTA1-DD as a Mucosal Adjuvant for an Inactivated Influenza Vaccine

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Biomedical and Environmental Sciences 2019年第7期32卷 531-540页

作者： FAN Xue Ting WANG Yun Long SU Qiu Dong QIU Feng YI Yao JIA Zhi Yuan WANG Da Yan QIN Kun ZOU Ye Ning BI Sheng Li SHEN Li Ping National Institute for Viral Disease Control and Prevention Chinese Center for Disease Control and Prevention Beijing 102206 China Henan Bioengineering Research Center Zhengzhou 4500466 Henan China sinovac biotech Co. Ltd. Beijing 100085 China

Objective To evaluate the effect of intranasal immunization with CTA1-DD as mucosal adjuvant combined with H3N2 split vaccine. Methods Mice were immunized intranasally with PBS(negative control), or H3N2 split vaccine(3 μg/mouse) alone, or CTA1-DD(5 μg/mouse) alone, or H3N2 split vaccine(3 μg/mouse) plus CTA1-DD(5 μg/mouse). Positive control mice were immunized intramuscularly with H3N2 split vaccine(3 μg/mouse) and alum adjuvant. All the mice were immunized twice, two weeks apart. Then sera and mucosal lavages were collected. The specific HI titers, IgM, IgG, IgA, and IgG subtypes were examined by ELISA. IFN-γ and IL-4 were test by ELISpot. In addition, two weeks after the last immunization, surivival after H3N2 virus lethal challenge was measured. Results H3N2 split vaccine formulated with CTA1-DD could elicit higher Ig M, Ig G and hemagglutination inhibition titers in sera. Furthermore, using CTA1-DD as adjuvant significantly improved mucosal secretory Ig A titers in bronchoalveolar lavages and vaginal lavages. Meanwhile this mucosal adjuvant could enhance Th-1-type responses and induce protective hemagglutination inhibition titers. Notably, the addition of CTA1-DD to split vaccine provided 100% protection against lethal infection by the H3N2 virus. Conclusion CTA1-DD could promote mucosal, humoral and cell-mediated immune responses, which supports the further development of CTA1-DD as a mucosal adjuvant for mucosal vaccines.

关键词： Adjuvants H3N2 Influenza Mucosal immunization Split vaccine

Safety and Effectiveness of SA58 Nasal Spray Against COVID-19 Infection in Medical Personnel:An Open-Label,Blank-Controlled Study—Hohhot City,Inner Mongolia Autonomous Region,China,2022

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China CDC weekly 2023年第10期5卷 218-222页

作者： Shujie Si Canrui Jin Jianping Li Yunlong Cao Biao Kan Feng Xue Xiaoliang Sunney Xie Liang Fang Gang Zeng Shuo Zhang Yaling Hu Xiaoping Dong Pharmacy Department Inner Mongolia Fourth HospitalHohhot CityInner Mongolia Autonomous RegionChina Clinical Research and Development Department Sinovac Biotech Co.Ltd.BeijingChina Biomedical Pioneering Innovation Center(BIOPIC) Peking UniversityBeijingChina Changping Laboratory BeijingChina State Key Laboratory for Infectious Disease Prevention and Control NHC Key Laboratory of Medical Virology and Viral DiseasesNational Institute for Viral Disease Control and PreventionChinese Center for Disease Control and PreventionBeijingChina Research and Development Department Sinovac Life Sciences Co.Ltd.BeijingChina Inner Mongolia Blood Center Hohhot CityInner Mongolia Autonomous RegionChina Center for Biosafety Mega-Science Chinese Academy of SciencesWuhan CityHubei ProvinceChina China Academy of Chinese Medical Sciences BeijingChina Shanghai Institute of Infectious Diseases and Biosafety ShanghaiChina

Summary What is already known about this topic?The active ingredient of the SA58 Nasal Spray is a broad-spectrum neutralizing antibody with a high neutralizing capacity against different Omicron subvariants in vitro studies.What is added by this report?This study demonstrated the safety and effectiveness of SA58 Nasal Spray against coronavirus disease 2019(COVID-19)infection in medical personnel for the first time.What are the implications for public health practice?This study provides an effective approach for the public to reduce their risk of COVID-19 infection.The findings of this research have the potential to significantly reduce the risk of infection and limit human-to-human transmission in the event of a COVID-19 outbreak.

关键词： neutral COV Nasal

Factors Associated with SARS-CoV-2 Repeat Positivity—Beijing,China,June–September 2020

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China CDC weekly 2022年第5期4卷 88-95,I0006-I0010页

作者： Siqi Li Xiaoli Wang Li Li Yang Pan Siyuan Yang Dawei Tan Ying Shen Peng Yang Naor Bar-Zeev Yaling Hu Jacky MJennings Simin Li Linghang Wang Quanyi Wang Beijing Center for Disease Prevention and Control BeijingChina Department of International Health Johns Hopkins Bloomberg School of Public HealthBaltimoreMDUSA Beijing Municipal Key Laboratory of Clinical Epidemiology BeijingChina School of Public Health Capital Medical UniversityBeijingChina Emergency department of Infectious diseases Beijing Ditan HospitalCapital Medical UniversityBeijingChina Laboratory of Infectious Diseases Center of Beijing Ditan Hospital Capital Medical UniversityBeijingChina sinovac biotech Co LtdBeijingChina Department of Pediatrics Johns Hopkins School of MedicineBaltimoreMDUSA Yiducloud(Beijing)Technology Co. LtdBeijingChina

Introduction:Repeat positive severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)following COVID-19 initial viral clearance(repositivity)poses a public health management challenge.The objective was to determine factors associated with neutralizing antibody(Nab)level and re-positivity among patients infected with a single strain SARS-CoV-2.Methods:During a single strain SARS-CoV-2 cluster in Beijing,China,longitudinal individual clinical,virological,and immunological data were collected from 368 infections from June 13 to September 22,2020.Factors associated with Nab level and re-positivity were analyzed using generalized estimating equations.Results:A total of 353(96%)SARS-CoV-2 infections had demographic,clinical,and laboratory data available.Among the 353 infections,55(15.5%)were re-positive,and blood draws were taken from 346 individuals(98.0%)during hospitalization and/or during the follow-up period.Symptoms were milder for the second-time admission for the re-positives,although 36.4%of re-positives presented with radiographic appearance of pneumonia manifestation.Compared to non-re-positive patients,NAb titers were lower among re-positives;NAb was positively associated with clinical severity.Samples from the lower respiratory tract manifested higher viral load than that from the upper respiratory tract.Multivariable analysis showed re-positivity was positively associated with being female[odd ratio(OR)=1.7,95%confidence interval(CI)1.1–2.8]and being aged<18 years(OR=5.2,95%CI 1.5–18.1);having initially asymptomatic infection(OR=13.7,95%CI 1.6–116.3);and negatively associated with a higher NAb level(OR=0.9,95%CI 0.5–1.7).Conclusions:NAb may be important for sustained viral clearance.Lower respiratory tract infection was associated with higher viral load among all infections when compared to upper respiratory tract infection.Continuous lower respiratory and intermittent upper respiratory viral shedding among COVID-19 infections may occur.

关键词： sustained initially neutral

An Immunocompetent Patient with High Neutralizing Antibody Titers Who Shed COVID-19 Virus for 169 days——China,2020

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China CDC weekly 2021年第32期3卷 688-691,I0003-I0008页

作者： Li Li Siqi Li Yang Pan Ling Qin Siyuan Yang Dawei Tan Yaling Hu Maria Deloria Knoll Xiaoli Wang Linghang Wang Quanyi Wang Beijing Ditan Hospital Capital Medical UniversityBeijingChina Johns Hopkins Bloomberg School of Public Health BaltimoreMarylandUSA Beijing Center for Disease Control and Prevention BeijingChina Biomedical Information Center of Beijing YouAn Hospital Capital Medical UniversityBeijingChina sinovac biotech Co LtdBeijingChina

Few reports are available about prolonged shedding of coronavirus disease(COVID-19)virus,also known as severe acute respiratory syndrome coronavirus 2(SARS-CoV-2),by immunocompetent patients.We report a case of an infected,immunocompetent person with 169 days of COVID-19 virus shedding during which time he had two brief periods when he tested negative for COVID-19 followed by again testing positive.We describe relevant clinical,immunological,and genomic features.We found that continuous and prolonged viral replication and infectivity existed in an immunocompetent COVID-19 patient,despite having high neutralizing antibody titers.

关键词： Antibody acute respiratory

Modeling the Long-term Antibody Response and Duration of Immune Protection Induced by an Inactivated,Preservative-free Hepatitis A Vaccine(Healive)in Children

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Biomedical and Environmental Sciences 2020年第7期33卷 484-492页

作者： YU Yong Pei CHEN Jiang Ting JIANG Zhi Wei WANG Ling YU Cheng Kai YAN Xiao Yan YAO Chen XIA Jie Lai College of Military Preventive Medicine the Fourth Military Medical UniversityXi'an 710032ShaanxiChina Peking University^Clinical Research Institute Peking University Health Science CenterBeijing 100191China sinovac biotech Beijing 100089China Beijing Keytech Statistical Consulting Beijing 100020China

Objective Long-term seroprotection via the hepatitis A vaccine is essential for the prevention of disease from the hepatitis A virus(HAV).Due to documented difficulties during decade-long follow-ups after receiving vaccines,statistical-modeling approaches have been applied to predict the duration of immune protection.Methods Based on five-year follow-up data from a randomized positive-controlled trial among Chinese children(1–8 years old)following a 0,6 months vaccination schedule,a power-law model accounting for the kinetics of B-cell turnover,as well as a modified power-law model considering a memory-B-cell subpopulation,were fitted to predict the long-term immune responses induced by HAV vaccination(Healive or Havrix).Anti-HAV levels of each individual and seroconversion rates up to 30 years after vaccination were predicted.Results A total of 375 participants who completed the two-dose vaccination were included in the analysis.Both models predicted that,over a life-long period,participants vaccinated with Healive would have close but slightly higher antibody titers than those of participants vaccinated with Havrix.Additionally,consistent with previous studies,more than 90%of participants were predicted to maintain seroconversion for at least 30 years.Moreover,the modified power-law model predicted that the antibody titers would reach a plateau level after nearly 15 years post-vaccination.Conclusions Based on the results of our modeling,Healive may adequately induce long-term immune responses following a 0,6 months vaccination schedule in children via induction of memory B cells to provide stable and durable immune protection.

关键词： Hepatitis A Inactivated hepatitis A vaccine Modeling Antibody persistence Long-term follow-up