大学生伤寒Vi多糖菌苗接种效果观察

为积极有效地预防伤寒，我们于1996年4月在本校北院组织了大学生伤寒Vi多糖菌苗的接种及接种前后血清学效果观察，现将结果报道如下。1对象与方法1．1观察对象采用分层随机抽样法，在我校九三。九四、九五级接种伤寒Vi多糖菌苗的本科大学生中，于接种前和接种后一个月，分别抽取静脉血3ml，分离血清后置－20℃冻存备查。12菌苗来源及接种方法伤寒Vi多糖菌苗由卫生部成都生物制品研究所提供，批号950652，30pg肌肉注射，有效期内使用。1．3检测方法及结果判定采用间接血凝法测定血清Vi抗体。致敏与非致敏血球由中国药品生物制品检定所提供…     

接种伤寒Vi多糖菌苗的长期效果评价

1992年我国研制出伤寒Vi多糖菌苗，短期效果观察结果表明，稳定性和安全性均比较好。为了解接种伤寒Vi多糖菌苗的长期效果，由国际疫苗研究所(International Vaccine lnstitute)DOMI项目组资助，我们在国内第一个伤寒Vi多糖菌苗大规模试验现场江苏宝应县进行了本项研究。结果报告如下。     

伤寒Vi多糖菌苗人体接种反应与血清学观察

1993年3～10月在江苏省宜兴市对我国研制成功的伤寒Vi多糖菌苗以不同浓度不同注射途径进行接种反应及血清学效果观察,并以伤寒菌苗及Vi多糖菌苗的稀释液作为对照。结果表明30μg皮下组最优,其体温中反应率为2.59%,局部红肿的中和反应率24小时仅2.59%48小时全部消退。接种前GMT为5.43,接种后1个月上升到50.18四倍增长率达91.6%,接种后6个月仍保持在38.18。30μg肌肉组接种反应与30μg皮下组相似,但抗体水平的下降幅度较后者快。20μg皮下组的接种反应不比30μg皮下组轻,接种后1个月的GMT较后者低。伤寒菌苗组局部中强反应率显著高于Vi菌苗各组。笔者认为Vi多糖菌苗全身和局部反应是轻微的,免疫原性是好的,初次接种只需注射一针次,该苗在伤寒预防上有着广阔的前景。     

国产与法国Merieux产伤寒Vi多糖菌苗免疫持久性观察

为了解国产伤寒Vi菌苗和法国菌苗的免疫持久性,于1995年在江苏省某中学12～16岁学生中进行血清学观察.结果表明,免后1个月血清Vi抗体滴度明显上升,国产菌苗和法国菌苗抗体的GMT分别为36.94和35.49,四倍增长率分别为91.80%和89.66%;免后6个月Vi抗体的GMT分别为15.38和15.80,四倍增长率分别为61.22%和59.09%;免后12个月Vi抗体的GMT分别为15.38和12.07,四倍增长率分别为55.10%和51.06%.二菌苗Vi抗体的GMT和四倍增长率非常相近.表明国产伤寒Vi多糖菌苗的质量已达到国外同类产品的水平.     

伤寒Vi多糖菌苗免疫效果观察

通过对１５０名学生接种伤寒Ｖｉ多糖菌苗后３年追踪观察表明：接种伤寒Ｖｉ多糖菌苗后体内可快速产生Ｖｉ抗体，免后１月抗体阳性率为９７．３％，ＧＭＴ为３８．３４，且Ｖｉ抗体在体内至少可维持２年以上的较高水平；免后３年加强１针，Ｖｉ体内至少可维持２年以上的较高水平；阳性率为８３．３％，ＧＭＴ为２５，２０，但没有达到初免后１月水平。结合伤寒Ｖｉ多糖菌苗流行病学观察资料，说明伤寒Ｖｉ多糖菌苗接种后人体至少有２     

湖南师大学生伤寒菌毛抗原多糖菌苗免疫效果观察

为了解湖南师范大学学生接种伤寒菌毛抗原 (Ｖｉ)多糖菌苗效果 ,积极有效地预防伤寒病 ,笔者从 1996年 4月起 ,对本校大学生接种伤寒Ｖｉ多糖菌苗的效果进行了观察 ,现将结果报道如下。1　对象与方法1.1　对象 :采用随机抽样法 ,在湖南师范大学 1995级学生中抽取 96人 ,其中男生 5 7人 ,女生 39人。1.2　菌苗来源及接种方法 :伤寒Ｖｉ多糖菌苗由卫生部成都生物制品研究所提供 ,批号 95 0 6 5 2 ,30 μｇ ,上臂外侧三角肌处肌内注射 ,有效期内使用。1.3　检测方法及结果判定 :分别于接种前后 1个月 ,抽取静脉血 3ｍｌ,分离血清后置 -2 0℃冻…     

伤寒Vi多糖菌苗流行病学效果观察

对我国研制的伤寒Vi多糖菌苗进行接种反应及流行病学效果观察，并以其稀释液作为对照，对777名接种者的反应观察结果表明，菌苗组发热弱、中反应率分别为16．93％和0．05％，对照组分别为15．01％和0．03％．两者发热反应率无显著差异。菌苗组仅出现2例局部轻反应。对81506名接种者观察，以血培养伤寒杆菌阳性作为病人诊断标准，菌苗的保护指数为3．49，保护率为71．35％。临床资料显示，接种组发病者的发热强度明显低于对照组发病者。作者认为该苗全身、局部反应轻微，安全性好，保护率较高，发病者可降低发热强度，且初免只需注射一针，是一种值得推广使用的新一代菌苗。     

国产与法国Merieux产伤寒Vi多糖菌苗人体接种反应与血清学效果观察

为评价国产伤寒Ｖｉ 多糖菌苗的质量，作者对国产伤寒菌苗和法国菌苗进行了人体接种反应和血清学抗体的免疫持久性观察。结果表明接种伤寒Ｖｉ 多糖菌苗的全身反应和局部反应都很轻，是相当安全的；免后１ 个月、６ 个月和１２ 个月Ｖｉ抗体的阳转率和ＧＭＴ，国产菌苗与法国菌苗均没有显著性差异，表明国产伤寒Ｖｉ 多糖菌苗的质量已达到国外同类产品的水平     

A+C群脑膜炎球菌多糖疫苗安全性评估

目的 评估A＋C群脑膜炎球菌多糖疫苗的安全性。方法 以A＋C群脑膜炎球菌多糖疫苗为观察组，伤寒Vi多糖疫苗为对照组，按整群随机分层配对的原则，将研究现场分为108个组群，观察组和对照组各分配54个组。对两组同时建立接种反应监测系统，按统一表格和方法对两组的接种反应进行监测、记录，并进行流行病学调查。结果 两组共接种34543人，其中A＋C群脑膜炎球菌多糖疫苗接种18167人，伤寒Vi疫苗接种16376人。A＋C群脑膜炎球菌多糖疫苗速发接种反应率为0．44‰，一般接种反应率为0．38％o；伤寒Vi疫苗速发接种反应率为0．79％，一般接种反应率为0．73％o；跟踪随访接种反应对象共1239人，其中接种A＋C群脑膜炎球菌多糖疫苗的771人，接种伤寒Vi疫苗的468人。接种后第1天，A＋C群脑膜炎球菌多糖疫苗组的局部反应发生率要明显高于伤寒Vi疫苗（X^2。=13．98，P=0．0002）；接种后第2—3天局部反应和全身反应的发生率，两组差异无统计学意义；两组各自接种人群和未接种人群发热发生率的差异无统计学意义，两组已接种人群的发热发生率差异也无统计学意义；两组均未发现严重反应。结论 A＋C群脑膜炎球菌多糖疫苗与伤寒Vi疫苗均可在不同年龄组人群开展大规模接种，局部及全身接种反应轻微，接种反应率低，有良好的安全性。     

伤寒Vi多糖菌苗免疫效果观察

伤寒—副伤寒甲乙三联菌苗 (ＴＡＢ)因需免疫三次 ,且接种反应重 ,往往不能完成全程免疫而影响其效果。 90年代初期研制的伤寒Ｖｉ多糖菌苗只需注射一针 ,接种反应少 ,保护率达到71 3 5 %[1] ,是目前公认的理想疫苗。关于该疫苗免疫学效果 ,国内报道不多。 1998年 9月 ,本地区下陈镇伤寒暴发 ,我们对疫区易感人群应急接种伤寒Ｖｉ多糖菌苗 ,并对免疫效果进行观察 ,现将结果报告如下。1　对象与方法1 1　对象　伤寒接触者、饮食服务人员、水厂工作人员、幼儿和中小学生及企业职工 ,接种 65 2 5人。随机选择其中部分中学生和企业职工 194人 …     

Impact of Vi vaccination on spatial patterns of typhoid fever in the slums of Kolkata, India

A mass typhoid Vi vaccination campaign was carried out among approximately 60,000 slum residents of Kolkata, India. This study evaluated the impact of the campaign on spatial patterns of typhoid fever. Eighty contiguous residential groups of households in the study area were randomized to receive either a single dose of the Vi polysaccharide vaccine or a single dose of the inactivated hepatitis A vaccine as the control agent. Persons aged two years and older were eligible to receive the vaccine. Vaccine protection against typhoid fever was monitored for two years after vaccination at both outpatient and inpatient facilities serving the study population. Geographic analytic and mapping tools were used in the analysis. Spatial randomness of the disease was observed during the pre-vaccination period, which turned into a significant pattern after vaccination. The high-risk areas for typhoid were observed in the area dominated by the control clusters, and the low-risk areas were in the area dominated by the Vi clusters. Furthermore, the control clusters surrounded by the Vi clusters were low risk for typhoid fever. The results demonstrated the ability of mass vaccination to change the spatial patterns of disease through the creation of spatial barriers to transmission of the disease. Understanding and mapping the disease risk could be useful for designing a community-based vaccination strategy to control disease.     

A+C群脑膜炎球菌多糖疫苗接种反应与血清学观察

目的观察国产A C脑膜炎多糖疫苗(A C疫苗)的接种反应和免疫原性。方法以A C疫苗为观察苗、伤寒Vi多糖疫苗(Vi疫苗)为对照苗,采样用整群随机对照的临床试验方法,确定观察人群和对照人群。在已接种的两组人群中,采取整群分层抽样的方法抽取接种反应观察对象,并进行连续3天随访以观察接种反应。采集部分A C疫苗接种对象免前、免后血标本,检测血清抗体IgG4倍增长情况。结果共随访接种反应观察对象1239人,其中接种流脑A C疫苗的771人、接种伤寒Vi疫苗的468人。A C疫苗接种后第1天局部反应发生率为15.06%,第2天的为0.13%,第3天的为0;接种后第1天全身反应的发生率为1.16%,第2天为0.39%和第3天为0.13%。除接种后第1天A C疫苗的局部反应发生率要明显高于Vi疫苗的外,接种后2天、3天的局部反应和第1、2、3天全身反应的发生率,A C疫苗和Vi疫苗无显著性差异。共采集A C疫苗接种对象免前、免后血标本各100份,抗C群脑膜炎球菌抗体4倍增长率达到94%,抗A群脑膜炎球菌抗体仅达到62%。结论A C疫苗和伤寒Vi多糖疫苗一样,接种反应轻微,安全性好;抗C群脑膜炎球菌抗体免疫应答良好。接种前人群血清抗A群脑膜炎球菌抗体平均浓度比抗C群的高2.6倍,抗A群脑膜炎球菌抗体4倍增长率低可能与本底抗A群脑膜炎球菌抗体水平高有关。     

Evaluation of immune responses to an oral typhoid vaccine,Ty21a,in children from 2 to 5 years of age in Bangladesh

Young children are very susceptible to typhoid fever, emphasizing the need for vaccination in under five age groups. The parenteral Vi polysaccharide vaccine is not immunogenic in children under 2 years and the oral Ty21a vaccine (Vivotif) available in capsular formulation is only recommended for those over 5 years.     

A Japanese study to assess immunogenicity and safety of a typhoid Vi polysaccharide vaccine

BackgroundAlthough typhoid fever is rare in Japan, imported cases have been reported occasionally in travelers returning from endemic areas. To achieve licensing of a typhoid Vi polysaccharide vaccine (Typhim Vi^®) and make it widely available in Japan, this study was conducted at the request of the Japanese Ministry of Health Labor and Welfare to assess the immunogenicity and safety of this vaccine when given as a single dose (the recommended schedule of administration) in a Japanese population.MethodsIn this multi-center, open-label, non-comparative, intervention study performed in Japan, 200 healthy volunteers (188 adults [≥18 years of age], 7 adolescents [12–17 years of age] and 5 children [2–11 years of age]) were administered Typhim Vi^®. Immunogenicity was assessed 28 days after vaccinations using an ELISA method of anti-Vi antibody detection. A 4-fold increase in anti-Vi titer was considered as the threshold for seroconversion for anti-Vi antibodies. Safety was assessed up to 28 days following vaccination.ResultsOverall, 92.0% (95% confidence interval [CI]: 87.3–95.4%) of participants achieved seroconversion 28 days after a single dose of typhoid Vi polysaccharide vaccine. GMTs of Vi antibody titers increased from 6.6 (95% CI: 5.8–7.4) prior to vaccination to 157.3 (95% CI: 135.1–183.2) on Day 28 after vaccination. The geometric mean of individual anti-Vi antibody titer ratios (Day 28/Day 0) was 23.9 (95% CI: 20.3–28.3). There were no immediate adverse events and no adverse events led to the discontinuation of participants from the study. Across all age groups, pain and myalgia were the most frequently reported injection site and systemic reactions, respectively. Most of these reactions were mild in intensity and resolved within 7 days.ConclusionsA single dose of typhoid Vi polysaccharide vaccine, Typhim Vi^®, demonstrated good safety and immunogenicity profile in a Japanese population.     

Assessment of potential effects of the electromagnetic fields of mobile phones on hearing

Background

One of the goals of this study was to learn the coverage, safety and logistics of a mass vaccination campaign against typhoid fever in children and adults using locally produced typhoid Vi polysaccharide (PS) and group A meningococcal PS vaccines in southern China.

Methods

The vaccination campaign targeted 118,588 persons in Hechi, Guangxi Province, aged between 5 to 60 years, in 2003. The study area was divided into 107 geographic clusters, which were randomly allocated to receive one of the single-dose parenteral vaccines. All aspects regarding vaccination logistics, feasibility and safety were documented and systematically recorded. Results of the logistics, feasibility and safety are reported.

Results

The campaign lasted 5 weeks and the overall vaccination coverage was 78%. On average, the 30 vaccine teams gave immunizations on 23 days. Vaccine rates were higher in those aged ≤ 15 years (90%) than in adolescents and young adults (70%). Planned mop-up activities increased the coverage by 17%. The overall vaccine wastage was 11%. The cold chain was maintained and documented. 66 individuals reported of adverse events out of all vaccinees, where fever (21%), malaise (19%) and local redness (19%) were the major symptoms; no life-threatening event occurred. Three needle-sharp events were reported.

Conclusion

The mass immunization proved feasible and safe, and vaccine coverage was high. Emphasis should be placed on: injection safety measures, community involvement and incorporation of mop-up strategies into any vaccination campaign. School-based and all-age Vi mass immunizations programs are potentially important public health strategies for prevention of typhoid fever in high-risk populations in southern China.     

5～60岁人群伤寒Vi多糖疫苗和A群脑膜炎球菌多糖疫苗大规模接种结果分析

为考核国产伤寒Vi多糖疫苗在现场试验的效果 ,以A群脑膜炎球菌多糖疫苗为对照 ,对广西壮族自治区河池市城市和农村的 5～ 6 0岁居民进行了一次大规模接种。结果显示 :应接种对象 1180 71人 ,实际接种 92 4 76人 ,接种率为 78 32 % ,其中伤寒Vi多糖疫苗为 76 87% ,A群脑膜炎球菌多糖疫苗为 79 6 9% ;接种率最高的组群接种率为 92 4 8% ,最低为 6 5 2 0 %。按城乡划分 ,城区的接种率为 77 2 9% ,农村的接种率为 80 5 8% ,组群接种率的高低分布无明显的地理性差异。 5～ 9岁接种率最高为 89 6 5 % ,2 0～ 2 9岁接种率最低为 6 9 0 7% ;男女接种率分别为79 0 7%和 82 11%。有 6 6人被观察到或报告出现不良反应 ,不良反应发生率为 71 37/ 10万。表明两种疫苗的安全性好。在大规模疫苗接种中 ,充分发挥当地干部的宣传组织作用 ,并把接种的有关信息提前通知当地居民 ,对于提高接种率十分重要。补漏接种能使接种率低的组群得到显著的提高。在大规模疫苗接种中必须严格遵守安全注射操作程序 ,避免发生不安全注射事故。两种疫苗的平均接种率、年龄别接种率、性别接种率、组群接种率的地理分布均达到了较好均衡性 ,是可比的 ,为今后考核疫苗效果提供了良好的现场背景     

Duration of Vi antibodies in participants vaccinated with Typhim Vi (Typhoid Vi polysaccharide vaccine) in an area not endemic for typhoid fever

After a single injection of Typhim Vi^® (typhoid Vi polysaccharide vaccine), serum antibody concentrations were monitored for 3 years in 37 adults who resided where typhoid fever was not endemic. Anti-Vi antibody concentrations declined progressively during the study, to levels that support the current US recommendation for revaccination every 2 years.     

The cost-effectiveness of typhoid Vi vaccination programs: calculations for four urban sites in four Asian countries

The burden of typhoid fever remains high in impoverished settings, and increasing antibiotic resistance is making treatment costly. One strategy for reducing the typhoid morbidity and mortality is vaccination with the Vi polysaccharide vaccine. We use a wealth of new economic and epidemiological data to evaluate the cost-effectiveness of Vi vaccination against typhoid in sites in four Asian cities: Kolkata (India), Karachi (Pakistan), North Jakarta (Indonesia), and Hue (Vietnam). We report results from both a societal as well as a public sector financial perspective. Baseline disease burden estimates in the four areas are: 750 cases per year in two Kolkata neighborhoods (pop 185,000); 84 cases per year in the city of Hue (pop 280,000); 298 cases per year in two sub-districts in North Jakarta (pop 161,000), and 538 cases per year in three squatter settlements in Karachi (pop 102,000). We estimate that a vaccination program targeting all children (2-14.9) would prevent 456, 158, and 258 typhoid cases (and 4.6, 1.6, and 2.6 deaths), and avert 126, 44, and 72 disability-adjusted life years (DALYs) over 3 years in Kolkata, North Jakarta and Karachi, respectively. The net social costs would be US$160 and US$549, per DALY averted in Kolkata and North Jakarta, respectively. These programs, along with a similar program in Karachi, would be considered "very cost-effective" (e.g. costs per DALY averted less than per capita gross national income (GNI)) under a wide range of assumptions. Community-based vaccination programs that also target adults in Kolkata and Jakarta are less cost-effective because incidence is lower in adults than children, but are also likely to be "very cost-effective". A program targeting school-aged children in Hue, Vietnam would prevent 21 cases, avert 6 DALYs, and not be cost-effective (US$3779 per DALY averted) because of the low typhoid incidence there.     

Efficacy trial of Vi polysaccharide vaccine against typhoid fever in south-western China

OBJECTIVE: To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. METHODS: A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). FINDINGS: After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. CONCLUSION: The slightly higher dose of vaccine did not seem to alter efficacy significantly in China.     

Sociobehavioural research methods for the introduction of vaccines in the Diseases of the Most Impoverished Programme

Participation in vaccination campaigns worldwide, particularly the Expanded Programme on Immunization, has increased significantly in recent years. However, there remain multiple and integrated behavioural, sociocultural and political-economic barriers to vaccination. The Diseases of the Most Impoverished (DOMI) Programme has undertaken shigellosis disease-burden studies and oral cholera and typhoid Vi polysaccharide vaccine trials in seven Asian countries. As part of these projects, sociobehavioural studies have been undertaken to determine the potential demand for vaccines for these diseases and the obstacles and enabling factors that may affect acceptance, delivery, and use of vaccines. A theoretical model of acceptance of vaccination and a triangulation of qualitative and quantitative methods have been used for fully elucidating the range of issues relating to vaccination for shigellosis, cholera, and typhoid fever. In this paper, the theoretical and methodological basis of the DOMI projects has been reviewed in a context of current sociobehavioural research on the acceptability and desirability of vaccination.