不同效价出血热灭活疫苗人体接种后的中和抗体应答？…

以不同效价的出血热疫苗免疫人体后,４批效价合格的疫苗中和抗体阳性转率达８７￣１００％,抗体ＧＭＴ达１５￣１８而一批未达合格标准的疫苗阳转率只有６０％,ＧＭＩ７．１;免疫血清对同毒株的抗体阳转率为１００％,对异型只为２５％,为保证疫苗在人体应用的有效性,应研究及制备ＨＩＮ和ＳＥＯ两型的双价疫苗。     

甲型肝炎减毒活疫苗H_2株的免疫效果

1987年5月以来,分3批为11451人接种了甲型肝炎减毒活疫苗H_2株(甲肝疫苗),对其中785人于接种后进行了血清甲肝抗体检测,甲肝抗体阳转率达92.9%,开始阳转的时间为接种后2周～5周,抗体滴度1∶2～1∶32。首批接种者抗体阳转已持续     

宁夏阿拉善黄鼠鼠疫抗体动态及鼠疫菌检出率的关系

阿拉善黄鼠感染鼠疫菌５ｄ出现抗体，２１～２３ｄ为高峰，阳性率为１００％，阳性滴度为ＧＭＴ９６９～１１３０，１００ｄ仍有阳性；鼠疫菌感染黄鼠２ｄ检出鼠疫菌，３～４ｄ达高峰，阳性率为１００％，以后逐渐下降，７ｄ后很少出现菌血症，仅有感染局部带菌。在鼠疫流行高峰期，抗体滴度高，检菌率也高；鼠疫流行处于末期或静息期，就很难检出鼠疫菌。因此在鼠疫监测工作中，检菌和检查鼠疫抗体应同步进行。     

广州市国产冻干无佐剂狂犬病疫苗使用人群狂犬病毒抗体检测情况

目的了锯注射国产冻干无佐剂狂犬病疫苗使用后的免疫效果并与非冻干狂犬病疫苗比较。方法一部分冻干国产无佐剂狂犬病疫苗受免者与非冻干疫苗受免者一样在5针全程免疫后第14天抽血并采用免疫酶联吸附法检查狂犬病毒抗体阳转情况，另一部分则在注射完第4针后即进行检查，之后比较检查结果。结果使用国产冻干无佐剂狂犬病疫苗受免者抗体阳转率为96．13％（794／826），而使用非冻干狂犬病疫苗受免者狂犬病毒抗体阳转率为89．84％（115／128），经X^2检验，两者差异有非常显著性（P〈0．01）。此外使用冻干狂犬病疫苗受免者在5针全程免疫后过15天进行检查其狂犬病毒抗体阳转率为98．90％（179／181），与在注射完第4针后即进行检查的抗体阳转率79．14％（645／815）相比较，经X^2检验其差异也有显著性（P〈0．05）。结论本文资料说明国产冻干无佐剂狂犬病疫苗较之非冻干疫苗更有效，其5针全程免疫后过15天检查狂犬病毒抗体阳转率可达98％～100％，而且符合卫生部的要求不含AL（OH）辅助剂。     

Vero细胞狂犬病疫苗的免疫原性研究

目的研究Ｖｅｒｏ细胞狂犬病疫苗的安全性和免疫原性。方法对１１例暴露狂犬病病人进行常规５针注射Ｖｅｒｏ细胞狂犬病疫苗（ＰＶＲＶ）,在注射后的不同时间抽取静脉血,用小鼠中和试验（ＭＮＴ）等方法检测病人体内的中和抗体水平。结果显示３种不同的方法在第０、７天时的体内中和抗体均未达到保护水平（＜０．５ＩＵ／ｍｌ）;１４天时病人的中和抗体全部阳转,ＧＭＴ为７．３２ＩＵ／ｍｌ;２８天时中和抗体达到最高值,ＧＭＴ为１４．５８ＩＵ／ｍｌ;９０天和１８０天的ＧＭＴ分别为８．４３和３．３８ＩＵ／ｍｌ,阳性率仍为１００％,抗体仍保持在较高水平。整个观察过程中无１例发性过敏反应。结论ＰＶＲＶ具有良好的安全性和免疫原性     

小剂量HB疫苗注射次数对产生HBsAb的研究

本文进行小剂量HB疫苗注射次数对诱导机体产生HBsAb的研究结果发现，注射第5针后，HBsAb阳转率为83．56％，与大剂量（10μg）3针免疫法的HBsAb阳转率86．67％相接近。男性HBsAb阳转率为82．05％，女性阳转率为85．29％。注射3针后，再继续注射第4针及第5针时，HBsAb阳转率均有所提高，但注射第6针后，HBsAb阳转率仍与第5针相似，由此可见，小剂量HB疫苗免疫预防注射，以注射到第5针为宜。     

日本脑炎病毒DNA疫苗和基因工程亚单位颗粒疫苗的动物保护实验研究

目的　评价 3种日本脑炎病毒 (JEV)新型疫苗 ,即E蛋白病毒样颗粒 (VLPs)、DNA疫苗 (pV/JE)以及E蛋白颗粒 (Eps)的动物免疫效果。方法　BALB/c小鼠经 2次接种疫苗后 ,测定其病毒特异性的CTL活性、结合抗体、中和抗体 ,并以10LD5 0JEV攻击免疫小鼠 ,观察其保护效果。结果　各新型疫苗组的CTL活性为 33%～ 5 6 % ,灭活疫苗组为 2 2 % ,而载体和PBS对照组的CTL活性分别为 17%和 18%。一次免疫后 ,实验组小鼠血清结合抗体阳转率为 90 %。除DNA疫苗组外 ,各组小鼠的二次免疫血清抗体效价高于一次免疫的抗体效价 (P <0 0 5 ) ,且以VLPs加佐剂组小鼠血清抗体效价最高 ,Eps加佐剂组次之 ,均高于 pV/JE组和灭活疫苗组 (P <0 0 5 )。三种疫苗可诱发小鼠产生中和抗体。各实验组小鼠能够抵抗JEV的攻击 ,而对照组小鼠的死亡率为 37 5 %。结论　三种新型疫苗可以正确表达JEV的E蛋白表位 ,可诱发免疫小鼠产生抗JEV的中和抗体并有保护性作用 ,免疫效果优于灭活疫苗 ,有可能成为候选的JEV新型疫苗。     

人用狂犬病纯化疫苗(Vero细胞)临床观察及免疫学效果研究

目的　研究人用狂犬病纯化疫苗的安全性和保护性。方法　采用狂犬病疫苗暴露后免疫程序接种受试人群 ,I期临床接种 2 0人 ,II、III期临床接种 30 4人 ,观察注射后反应 ,采用小鼠脑内中和试验法测定其中 6 2人中和抗体水平。结果　全部受试者有 13.2 7%出现轻度副反应 ,无中强度副反应 ,中和抗体阳转率为 10 0 % ,中和抗体GMT为 11.89IU/ml。结论　该疫苗对人体安全且具有较好的免疫原性     

高危人群微量乙肝疫苗免疫效果动态观察及有关问题探讨

采用微量乙肝疫苗（总剂量６μｇ）对ＨＢＶ高流行区的居民进行随机、对照研究，发现免疫Ｉ组（疫苗〈８℃保存）Ｔ１２抗体阳转率和保护率分别为９０．８％和８７．０％，和对照组相比，有显著性差异（Ｐ〈０．０１）；和常规剂量（总剂量９０μｇ）相比，其抗体阳转和保护率基本相同。提示高流行区同样可以用微量乙肝疫苗进行了预防。采用室温存放的乙肝疫苗作为免疫Ⅱ组进行免疫效果观察，其免疫效果和保护率与免疫Ｉ组相比，基本     

钩端螺旋体外膜菌苗不同剂量的接种反应与免疫效果观察

本文报告了含有赖型和七日热型抗原的钩端螺旋体（简称钩体）外膜菌苗免疫４００余人,其中１００μｇ组免疫２００余人,２００μｇ组免疫２００余人,同时设菌体菌苗和安慰剂组各２００余人作为对照。结果反应轻微,仅个别对象出现轻微的体温升高和局部红肿反应,无强反应发生。一针免疫后抗体显著升高,阳转率黄疸出血群赖型达９８．１３％以上,七日热群七日热型达９６．２６％以上,ＧＭＴ分别为２２７．０９和５０．８３以上,较菌体菌苗二针免疫抗体高２倍以上,且免疫后３个月下降亦较菌体菌苗为缓。１００μｇ免疫后反应更为轻微,抗体水平满意,建议以每型１００μｇ外膜苗扩大使用。     

Nasopharyngeal secretory antibody response to poliovirus type 3 virion proteins exhibit different specificities after immunization with live or inactivated poliovirus vaccines

By using immunoblotting, neutralization, and ELISA, the development of secretory antibody responses to poliovirus type 3 virion proteins (VP1, VP2, VP3) and to intact or trypsin-treated poliovirus type 3 was studied in the nasopharyngeal secretions in groups of infants after immunization with live attenuated poliovirus vaccine (OPV), enhanced potency inactivated poliovirus vaccine (IPV-EP), or after combined vaccination with IPV-EP followed by OPV. After three doses of vaccine, infants in all vaccine groups developed similar secretory IgA response to VP1 and VP2. The antibody response to VP3 was observed in 76.5% of subjects immunized with OPV alone and approximately 60% of those immunized with IPV-EP followed by OPV. However, only 13% of those immunized with IPV-EP alone exhibited VP3-specific antibody response. Significant differences in poliovirus type 3 specific antibody activity were observed between OPV and IPV-EP immunized subjects when trypsin-treated poliovirus was used as the antigen for neutralization or for ELISA in vitro. The neutralizing antibody activity against cleaved virus was significantly higher than against whole virus in the OPV vaccinated subjects. Both neutralizing and ELISA antibody activity against cleaved virus was significantly lower than against the whole virus in IPV-EP immunized subjects.     

Vero细胞口服狂犬病疫苗的研究

本试验采用ＣＴＮ－１株经Ｖｅｒｏ细胞传１５代，病毒滴度均在７．０～８．０ｌｏｇＬＤ５０／ｍｌ之间。给８只犬分别口服８．１ｌｏｇＬＤ５０的疫苗３０天的中和抗体几何平均效价为１：１１０，中和抗体的平均国际单位为２．５９ＩＵ／ｍｌ，阳转率为１００％；给４只犬分别口服７．４３ｌｏｇＬＤ５０的疫苗，阳转率为５０％，中和抗体的平均国际单位为２．４８ＩＵ／ｍｌ。选用３５－６０日龄的乳犬１６只口服１０个剂量的疫苗，并在口服后５、１０、２０天、３个月各杀３只犬取脑及唾液腺分别在ＢＨＫ２１细胞上盲传２代，同时在昆明种小白鼠乳鼠脑内盲传２代，进行病毒分离，均为阴性，余下犬观察１２个月均正常。总之该口服狂犬病疫苗对犬具有较好的安全性及口服免疫原性。     

Demographic factors that influence the neutralizing antibody response in recipients of recombinant HIV-1 gp120 vaccines

We compared neutralizing antibody responses in human immunodeficiency virus (HIV) type 1 gp120 vaccine recipients by age, sex, and race. Four phase 1 or 2 trials involving 505 vaccinated subjects were analyzed. Age and sex had no detectable effect on neutralizing antibody responses. However, race influenced the response to one vaccine, MN gp120, in alum. Four inoculations with this vaccine generated higher serum titers of neutralizing antibodies in African Americans than in whites. Despite potent neutralization of T cell line-adapted HIV-1, serum from these African Americans failed to neutralize primary HIV-1 isolates. Neutralizing antibody responses did not differ between races when SF2 gp120 in MF-59 was administered either alone or with recombinant canarypox vCP205; they also did not differ when vCP1452 was administered either alone or with AIDSVAX B/B in alum. These data indicate that race may affect the neutralizing antibody response to some gp120 immunogens. To fully evaluate immunogenicity, clinical trials of candidate vaccines should enroll diverse populations of subjects.     

Safety of a live-attenuated Japanese encephalitis virus vaccine (SA14-14-2) for children

In a study begun in 1985, 1,026 children between the ages of 5 and 12 years, living in an area of low Japanese encephalitis (JE) infection, were vaccinated with live-attenuated JE vaccine, strain SA14-14-2. A group of 47 of the vaccinated children, 5-6 years of age, were examined for fever and other systemic reactions every other day for 2 weeks following vaccination. None of these children had temperatures greater than 37.4 degrees C or other systemic reactions during the observation period. No untoward reactions were reported in the remainder of the vaccinated group. After immunization, seroconversion rates in seronegative children were 100% (GMT 35.3, n = 11), 100% (GMT 31.7, n = 12), and 83.3% (GMT 23, n = 10) in groups receiving vaccine diluted 1:3, 1:5, and 1:50, respectively. These results indicate that the JE SA14-14-2 live-attenuated vaccine is immunogenic and safe for children.     

福建省新丙五价钩端螺旋体菌苗接种后反应与免疫效果的观察

目的对观察对象接种“福建新丙五价”钩体菌体苗基础免疫和一年后加强免疫的反应及效果进行观察。方法观察记录各针次疫苗接种后的反应并采集观察对象免疫前及免疫后20d,90d,180d,360d及再加强免疫后20d的6份血清,用显微镜凝集试验(MAT)测定各群抗体滴度,以抗体滴度≥1∶10为阳性判别标准,计算疫苗接种前后各次各群抗体阳转率和几何平均滴度GMT。结果观察对象均未出现全身反应,局部反应以复种为多,女性复种后反应比男性更严重,差异具有显著性意义。免疫后血清抗体阳转率及几何平均滴度(GMT)均比免疫前有显著的增长,且在免疫后3个月阳转率达高峰为95%以上,一年后维持50%左右,几何平均滴度(GMT)在基础免疫后1个月为1∶:60左右,半年后降为1∶20,一年后为1∶10。再次强化免疫,抗体阳转率迅速上升,高达100%,几何平均滴度(GMT)上升到1∶100。结论“福建新丙五价”钩体菌体苗的安全性及免疫效果是肯定的,只要加强钩体病的监测,菌苗的菌型与当地流行菌群吻合并按照规定程序免疫接种,完全可以预防钩体病的流行。     

Early antibody responses to rabies post-exposure vaccine regimens

The aim of post-exposure rabies vaccine treatment is to induce immunity, measured as neutralizing antibody, as fast as possible. This is especially important in the tropical rabies-endemic areas where simultaneous passive prophylaxis with hyperimmune serum is not practicable in the majority of cases. We compared the rate of production of antibody during the first two weeks, by six vaccine regimens in 118 subjects using two tissue culture vaccines, human diploid cell strain vaccine (HDCSV) and purified Vero cell rabies vaccine (PVRV). No antibody was detected on day 5. On day 7, the highest seroconversion rate was seen in subjects given HDCSV intramuscularly at two sites on days 0 and 3 (7 of 15), but this was not significantly different from the group with the lowest rate: the conventional single-site intramuscular regimen. All subjects had antibody by day 14, at which time the highest geometric mean titer was in the group vaccinated with 0.25 ml doses of diploid cell vaccine given subcutaneously at eight sites. This regimen, together with the standard single-site diploid cell vaccine and an eight-site intradermal regimen of the same product gave significantly higher titers than the two-site intramuscular regimens of either product. No single immunization schedule emerges as best, so the speed of antibody response, economy, and the skill needed for intradermal injection should be considered when deciding on the optimum regimen for use in a particular geographic area.     

Comparative study of reactogenicity and immunogenicity of new and established measles, mumps and rubella vaccines in healthy children

Summary  Concerns about the association of aseptic meningitis with measles-mumpsrubella (MMR) vaccines containing the Urabe Am 9 strain and the increasing worldwide demand for MMR vaccines, prompted the development of a new mumps vaccine strain (RIT 4385) by SmithKline Beecham Biologicals (SB) as part of a trivalent live attenuated MMR vaccine. The present study assessed the immunogenicity and reactogenicity of two lots of ‘Priorix’^* with a widely used and established vaccine M-M-R II (Merck & Co. Inc.) as comparator vaccine. 255 healthy children, 12 to 24 months of age, were enrolled in a single-blind study and randomly allocated to receive a single dose of one of two lots of “Priorix” or M-M-R II vaccine. Vaccinees were followed up for six weeks post-vaccination for solicited and unsolicited symptoms. Immunogenicity was determined in pre- and 60 days post-vaccination sera using commercial immunoassays for measles, mumps and rubella antibodies. There were no significant differences in immune responses between groups for any of the three vaccine components. In initially seronegative subjects, the respective post-vaccination seroconversion rates for ‘Priorix’ lots 1 and 2, and M-M-R II were 100, 100 and 97.6% for measles antibodies, 91.7, 95.1 and 94% for mumps antibodies and 100, 100 and 100% for rubella antibodies, respectively. GMTs for the three groups were 3,076, 3,641 and 3,173 mIU/ml for measles antibodies, 934, 900 and 1,043 U/ml for mumps antibodies, and 86.4, 87.5 and 97.1 IU/ml for rubella antibodies, respectively. The incidence of local symptoms was significantly lower for both ‘Priorix’ lots (17.6 and 15.3% for lots 1 and 2, respectively) than for M-M-R II (37.6%). Fever≧38.1°C during the six-week observation period occurred in approximately 25% of all subjects in all groups with no differences between the groups. No parotid/salivary gland swelling or signs of suspected meningism were reported, and there were no serious adverse events related to vaccination. The new MMR vaccine ‘Priorix’ containing the new RIT 4385 mumps strain was safe and had a significantly improved local tolerability profile over the comparator vaccine, M-M-R II, while eliciting an at least equivalent immune response.     

Humoral antibody kinetics with ChAdOx1-nCOV (Covishield™) and BBV-152 (Covaxin™) vaccine among Indian Healthcare workers: A 6-month longitudinal cross-sectional Coronavirus Vaccine-induced antibody titre (COVAT) study

Background and aimsThere is limited data available on longitudinal humoral antibody dynamics following two doses of ChAdOx1-nCOV (Covishield?) and BBV-152 (Covaxin?) vaccine against SARS-CoV-2 among Indians.MethodsWe conducted a 6-month longitudinal study in vaccinated healthcare workers by serially measuring quantitative anti-spike antibody at 3-weeks, 3-months and 6-months after the completion of second dose. Geometric mean titer (GMT) and linear mixed models were used to assess the dynamics of antibody levels at 6 months.ResultsOf the 481 participants, GMT of anti-spike antibody decreased by 56% at 6-months regardless of age, gender, blood group, body-mass index and comorbidities in 360 SARS-CoV-2 naive individuals but significantly more in hypertensives. Participants with past infection had significantly higher GMT at all time points compared to the naive individuals. Among SARS-CoV-2 naive cohorts, a significantly higher GMT was noted amongst the Covishield recipients at all time points, but there was a 44% decline in GMT at 6-month compared to the peak titer period. Decline in GMT was insignificant (8%) in Covaxin recipients at 6-month despite a lower GMT at all time points vs. Covishield. There was 5.6-fold decrease in seropositivity rate at 6-month with both vaccines. Participants with type 2 diabetes mellitus have a lower seropositivity rate at all the time points. Seropositivity rate was significantly higher with Covishield vs. Covaxin at all time points except at 6-month where Covaxin recipients had a higher seropositivity rate but no difference noted in propensity-matched analysis.ConclusionsThere is waning humoral antibody response following two doses of either vaccine at six months. Covishield recipients had a higher anti-spike antibody GMT compared with Covaxin at all-time points, however a significant decline in antibody titers was seen with Covishield but not with Covaxin at 6-months.     

Safety and immunogenicity of human rotavirus vaccine strain M37 in adults, children, and infants.

Rotavirus vaccine strain M37 (serotype 1), recovered from the stool of an asymptomatic newborn infant and serially passaged in cell culture, was given orally to adults, children, and infants. Serologic responses were detected by neutralization assay or EIA in 59% of 17 adults (10(5)-pfu dose), 55%-60% of 21 infants and children (10(4)-pfu dose), and 70% of 10 infants (10(5)-pfu dose), vaccine virus was shed by 24%, 20%-36%, and 70%, respectively. In adults, neutralizing antibody rises to strain M37 and the related serotype 1 strain Wa occurred with equal frequency (41% vs. 47%). In pediatric subjects, the former were more frequent (36%-40%) than the latter (10%-18%). This was also true of 8 infants who received two doses of vaccine. Mild gastrointestinal illnesses occurred with equal frequency in pediatric subjects who received vaccine or placebo. Thus, strain M37 was well tolerated and immunogenic in young infants, but elicited primarily vaccine-strain-specific rather than serotype-specific neutralizing antibody responses.     

浙江省肾综合征出血热(HFRS)-Ⅰ型鼠脑纯化疫苗安全性、血清学、防病效果和免疫策略研究

目的　现场观察、考核兰州生物制品研究所生产的HFRS -Ⅰ型鼠脑纯化疫苗的安全性、血清免疫学与防病效果 ,并确定其免疫程序和免疫策略。方法　试验组和对照组按随机整群分组法进行分组 ;采用 0、7、2 8d及免后 1年加强 1针的免疫程序 ;分别采集免前、全程接种后 2周、加强前、加强后两周、加强后 1、2、3、4、5年的部分接种者全血和微量耳垂血 ,分别测定其中和抗体和IFA抗体 ,观察疫苗的血清免疫学效果和现场流行病学防病效果。结果　在 1995年 8月～ 2 0 0 1年 12月的 6年时间里从疫苗开始接种到加强后 5年 ,观察了HFRS -Ⅰ型鼠脑灭活纯化疫苗的安全性、血清免疫学效果和流行病学防病效果等。纵观结果 :证明该疫苗除了因疫苗中残留蔗糖导致较重较普遍的局部反应外 ,未发现其他严重的副反应 ,证明疫苗有较好安全性。从血清免疫效果看 ,86例全程接种后两周的免疫者血清 ,IFA抗体阳转率达 10 0 % ,中和抗体阳转率为4 4 4 4 % (8/ 18)。 1年后 ,IFA抗体和中和抗体阳性率分别下降到 2 8 5 7%和 14 80 %。但加强后 2周的血清IFA抗体和中和抗体阳性率分别反弹至 83 33%和 5 5 5 6 % ,其抗体几何平均滴度也随之回升 ,但不十分明显。此外 ,在加强后 2年IFA和中和抗体阳性率再次下降到较低水平 ,分别为