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BackgroundBBIBP-CorV vaccine with two doses and an interval of 3-4 weeks had been proved to have good immunogenicity and efficacy as well as an acceptable safety profile according to our initial research and other similar studies. Maintaining adequate neutralizing antibody levels is also necessary for long-term protection, especially in the midst of the COVID-19 pandemic. Our aim was to evaluate the immune persistence of neutralizing antibody elicited by BBIBP-CorV vaccines with day 0-14, 0-21 and 0-28 schedule, and assess the immunogenicity and safety of a homologous booster dose in the high-risk occupational population aged 18-59 years. MethodsA total of 809 eligible participants, aged 18-59 years, were recruited and randomly allocated to receive BBIBP-CorV vaccine with day 0-14, 0-21 or 0-28 schedule respectively between January and May 2021 in Taiyuan City, Shanxi Province, China among the public security officers and the airport ground staff in initial study. In this secondary study, the responders (GMT [≥] 16) at day 28 after priming two-dose vaccine were followed up at months 3, 6 and 10 to evaluate the immune persistence of three two-dose schedules. At month 10, eligible participants of three two-dose schedules were received a homologous booster dose respectively (hereafter abbreviated as 0-14d-10m group, 0-21d-10m group and 0-28d-10m group), and followed up at day 28 post-booster to assess the safety and immunogenicity of the booster dose. The contents of follow-up included the blood samples, oropharyngeal/nasal swabs, and adverse reactions collection. The main outcomes of the study included geometric mean titers (GMT) of neutralizing antibody to live SARS-CoV-2, the positive rates of different criteria and the constituent ratio of GMT of neutralizing antibodies at different follow-up point. Meanwhile, we explored the kinetics of antibody levels of different vaccination regimens by generalized estimating equations (GEE) and used exponent curve model to predict the duration of maintaining protected antibody after the booster dose. We also determined predictors of maintaining protected antibody level within 10 months after the second dose by Cox proportional hazards regression model and nomogram. The trial was registered with ChiCTR.org.cn (ChiCTR2100041705, ChiCTR2100041706). ResultsThe number of 241, 247 and 256 responders (GMT [≥] 16) at day 28 after two-dose BBIBP-CorV vaccine in 0-14d, 0-21d and 0-28d schedule were followed-up at months 3, 6, and 10 for immune persistence evaluation. At month 10, a total of 390 participants were eligible and received a booster dose with 130 participants in the 0-14d-10m, 0-21d-10m and 0-28d-10m group respectively, of whom 74.1% (289/390) were male, with a mean age of 37.1{+/-}10.3 years. The GMT of neutralizing antibody in 0-28d-10m and 0-21d-10m group were significantly higher than 0-14d-10m group at month 3 (GMT: 71.6 & 64.2 vs 46.4, P<0.0001), month 6 (GMT: 47.1 & 42.8 vs 30.5, P < 0.0001) and month 10 (GMT: 32.4 vs 20.3, P < 0.0001; 28.8 vs 20.3, P=0.0004) after the second dose. A sharply decrease by 4.85-fold (GMT: 94.4-20.3), 4.67-fold (GMT: 134.4-28.8) and 4.49-fold (GMT: 145.5-32.4) was observed from day 28 to month 10 after the second dose in 0-14d-10m, 0-21d-10m and 0-28d-10m group, respectively, and they had similar decline kinetics (P=0.67). At 28 days after booster dose, a remarkable rebound in neutralizing antibody (GMT: 246.2, 277.5 and 288.6) were observed in three groups, respectively. Notably, the GMT after booster dose was not affected by priming two-dose schedule. The predictive duration of neutralizing antibody declining to the cutoff level of positive antibody response may be 18.08 months, 18.83 months and 19.08 months after booster dose in three groups, respectively. Long-term immune persistence within 10 months after the second dose was associated with age<40, female, and history of influenza vaccination. All adverse reactions were mild after the booster injection. None of the participants were infected SARS-CoV-2 during the trial period. ConclusionsThe priming two-dose BBIBP-CorV vaccine with 0-28 days and 0-21 days schedule could lead a longer persistence of neutralizing antibody than 0-14 days schedule. Maintaining long-term immune persistence was also associated with age<40, female, and history of influenza vaccination. Regardless of priming two-doses vaccination regimens, a homologous booster dose led to a strong rebound in neutralizing antibody and might elicit satisfactory persistent immunity.
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Vaccination is urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here, we conducted a randomized, parallel, controlled clinical trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval for high-risk occupational population. Participants were randomly assigned to receive two doses of inactivated SARS-CoV-2 vaccine (4 {micro}g per dose) at an interval of either 14 days, 21 days or 28 days. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Our results showed that the seroconversion rates (GMT [≥] 16) were all 100% in the three groups and the 0-21 and 0-28 groups elicited significantly higher SARS-CoV-2 neutralizing antibody level. All reported adverse reactions were mild. (Chinese Clinical Trial Registry: ChiCTR2100041705, ChiCTR2100041706)
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Objective:By analyzing the epidemiological characteristics of brucellosis in Shanxi Province, to provide scientific evidence of strategies for effective prevention and control of the disease.Methods:Surveillance data of human brucellosis from "Infectious Disease Report Information Management System" from 2008 to 2017 were statistically analyzed by descriptive epidemiological method. The time, regional and occupational distribution of brucellosis were analyzed.Results:A total of 54 845 cases of brucellosis occurred in Shanxi Province from 2008 to 2017. The average annual incidence was 15.37/100 000, fluctuated from 8.34/100 000 to 23.53/100 000. One death case was reported in 2015. The highest incidence was 23.53/100 000 in 2014 and the lowest reported incidence was 8.34/100 000 in 2017. Regional distribution range relatively focused on the north areas of Shanxi Province, the number of reported cases of Datong City was the largest (13 998 cases), accounting for 25.52%. The reported incidence of Shuozhou City was the highest (49.68/100 000). The disease was found each month throughout the year, the obvious incidence peak seasons were between March and July, accounting for 60.11% (32 966/54 845).The disease was most commonly found in 40-64 age groups (64.73%, 35 502/54 845). Occupational distribution of patients was mainly farmers (82.97%, 45 504/54 845).Conclusions:The epidemiology tendency of brucellosis in Shanxi Province is relatively controlled comparing with previous period, but even highly active in some local areas. The epidemic situation has spreading in both scope and population. It is necessary to carry out the propaganda of the protection knowledge of brucellosis in the key groups and enhance the self-protection consciousness of high-risk groups.
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Objective By analyzing the epidemiological characteristics of brucellosis in Shanxi Province,to provide a scientific basis in formulation of strategies for effective prevention and control of the disease.Method Surveillance data of human brucellosis from China Information System for Disease Control and Prevention between 2004 and 2013 were statistically analyzed by descriptive epidemiological method.The regional,time,age and sex,occupational distribution of brucellosis were analyzed.The prevalence trend of brucellosis in Shanxi Province was summarized.Results From 2004 to 2013,the total incidence presented a rising tendency and the highest reported incidence was 19.10/10 million in 2013.A total of 43 061 cases of brucellosis occurred in Shanxi Province.The average incidence of brucellosis was 12.52/10 million.Regional distribution range was relatively focused on the north areas of Shanxi Province,the number of reported cases of Datong City was the largest (12 157 cases),being 28.23％.The incidence of Shuozhou City was the highest (42.97/10 million).The epidemic was spreading through all county areas.The disease was found each month throughout the year,the obvious incidence peak seasons were between March and June.The disease was most commonly found in 15-64 age groups(87.19％,37 545/43 061).Occupation distribution of patients was mainly farmers (83.34％,35 887/43 061).Conclusions The situation of brucellosis epidemic in Shanxi Province is relatively serious;the reported incidence of brucellosis in Shanxi Province is in a rapid upward trend year by year,even highly active in some particular areas.Different regions should establish regional mechanisms for joint prevention and control and implement different prevention and control measures to comprehensively and sequentially control brucellosis.
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@#Objective To investigate the needs of rehabilitations in persons with mental retardation in Beijing.Methods 738 persons with mental retardation surveyed in the Second China National Sample Survey on Disability were involved,their rehabilitation condition and requisition were evaluated.Results 63.69% of them needed rehabilitation in community and family,73.31% needed rehabilitation training,their needs on medical service were met,needs on rehabilitation training were above provided service,needs on assistance articles and utensils were low,and needs on employment were high.Conclusion The case management system for persons with mental retardation should be built to meet their rehabilitation requisitions on different age and grade with various approaches.
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@#Objective To investigate the status of rehabilitation demands of persons with speech disability in Beijing.Methods 355 persons with speech disability in Beijing in the Second National Sample Survey were involved in the study;their rehabilitation status and demands were evaluated.Results Persons with speech disability mainly needed rehabilitation in institute and in community and family,rehabilitation training and medicine service were needed mainly;persons with speech disability at different age and handicapped grade had different rehabilitation demands.Conclusion Rehabilitation awareness of persons with speech disability should be improved,a group of staffs on speech rehabilitation are base to satisfy rehabilitation training demands.
