成人和儿童接种甲型肝炎灭活疫苗（Vero细胞）安全性和免疫原性研究

目的：评价甲型肝炎灭活疫苗（Vero细胞）在成人及儿童中接种的安全性及其免疫原性。方法选择6-16岁、16岁以上2组人群,采用0、6月免疫程序接种,观察该疫苗的不良反应,抗体阳转率和抗体几何平均滴度（GMT）。结果儿童和成人剂量组局部、全身反应发生率分别为2.83%、3.06%（χ2=0.451,P〉0.05）和10.3%、9.6%（χ2=1.424,P〉0.05）,差异均无统计学意义;免疫后1个月抗体阳转率分别为92.6%、93.5%（χ2=0.959,P〉0.05）,无统计学意义。两针全程免疫1月后两组抗体阳转率均达到100%,抗体几何滴度分别为16583mIU/ml、9762mIU/ml（tT1=1.65,P〉0.05;tT7=1.37,P〉0.05）,差异无统计学意义。结论维罗信甲型肝炎灭活疫苗（Vero细胞）在儿童和成人中应用具有良好的安全性和免疫原性。     

流行性乙型脑炎减毒活疫苗与灭活疫苗免疫效果及人体接种反应观察

目的:比较乙脑减毒活疫苗和灭活疫苗的免疫效果和安全性。方法:选择光泽县1～2周岁应初免的儿童264名,分组接种乙脑减毒活疫苗和乙脑灭活疫苗,观察人体接种反应,采用细胞蚀斑减少中和试验检测免疫前及免疫后乙脑中和抗体。结果:减毒活疫苗组抗体阳转率和抗体几何平均滴度(GMT)分别为91.30%和1∶20.22;灭活疫苗组为64.38%和1∶16.51。经统计学分析,减毒活疫苗组抗体阳转率和阳性抗体(GMT)均高于灭活组。经观察,减毒活疫苗组和灭活疫苗组人体反应均为发热和接种部位轻度红肿,发热率分别为8.51%和8.13%,中、强反应率为2.13%和0.81%,红肿率为1.42%和0.81%。所有发热及轻度红肿者均于24小时恢复正常。结论:乙脑减毒活疫苗免疫效果好,免疫针次少,安全性好,是现阶段预防乙脑比较理想的疫苗,适宜推广使用。     

宋内菌痢疾结合疫苗临床安全性和免疫原性观察

目的 观察宋内菌痢疾结合疫苗临床安全性和免疫原性。方法  按随机、双盲原则,以宋内菌痢疾结合疫苗为试验组。磷酸缓冲盐水为安慰剂对照组,进行临床安全性及免疫原性观察,比较试验组和对照组免疫后临床反应率、抗体阳转率和几何平均滴度(GMT)水平。结果 宋内菌痢疾结合疫苗接种后无严重全身反应和局部反应,与对照组比较,差异无统计学意义。试验组经2针全程免疫后2周和12周,抗体阳转率分别为87．46％和82．32％;GMT分别为1：3250．12和l：2432．76;抗宋内茵脂多糖(LPs)一IgG抗体滴度较免前平均增长倍数分别为10．7374和8．0353。全程免疫后试验组与对照组之间抗体阳转率、GMT、抗体滴度平均增长倍数比较,差异均有统计学意义。结论 宋内菌痢疾结合疫苗具有较好的安全性和免疫原性。     

876例犬咬伤者狂犬疫苗接种后效果观察

目的：探讨犬咬伤者狂犬疫苗接种后的效果。方法：876例被犬咬伤者接种狂犬疫苗,并在停止注射后的半个月（15d）采血,进行狂犬抗体的测定。结果：2006年抗体阳转率为82.01%,2007年提高到88.02%;0～9岁组接种狂犬疫苗后抗体阳转率达到94.48%,而≥50岁组较0～9岁组低,仅为65.47%,两者结果比较差异有统计学意义（P〈0.05）;男、女性别比较差异无统计学意义（P〉0.05）。结论：狂犬疫苗免疫之后抗体的产生与接种疫苗的剂量、免疫的次数以及机体的免疫反应因素有一定关系,接种狂犬疫苗之后按时进行狂犬抗体检测是必要的。     

冻干Vero细胞狂犬病纯化疫苗在120例门诊病人中的临床效果

目的:观察国产冻干非洲绿猴肾传代细胞(Vero细胞)为基质制备的狂犬病纯化疫苗临床应用的免疫效果和安全性。方法:选择门诊部就诊的犬致伤者240例,分为试验组和对照组。试验组接种冻干Vero细胞狂犬病纯化疫苗,对照组接种地鼠肾狂犬病纯化疫苗。2组人群均按照狂犬病疫苗暴露后常规免疫程序进行接种,于全程接种后15d测定中和抗体,并观察不良反应。结果:试验组抗体阳性率为96.7%,明显高于对照组的90.0%,P<0.05;不良反应发生率为10.8%,明显低于对照组的21.7%,P<0.05。结论:Vero细胞纯化疫苗抗体阳转率高、不良反应发生率低,临床应用优于地鼠肾纯化疫苗,适宜推广使用。     

甲型肝炎灭活疫苗在4～15岁儿童中的安全性、免疫原性和诱导抗体的持久性

法国 Pasteur Mérieux Connaught公司生产的甲型肝炎灭活疫苗由甲型肝炎病毒(HAV) GBM株制备 ,在成人中有较好的免疫原性和安全性。在本研究中 ,对 4～ 1 5岁儿童接种 2剂该疫苗 ,剂量为 0 .5 ml〔含 1 6 0抗原单位和 0 .3mg Al(OH) 3〕。然后检测其血清阳转率和抗 HAV抗体几何平均滴度(GMT) ,并观察局部和全身反应。　　结果表明 ,1 1 8名经改良的放射免疫法(RIA)检测抗 - HAV阴性的儿童 ,接种首剂疫苗后 2周 ,血清阳转率达 1 0 0 % ,抗体GMT为 73.7m IU/ml;2 4周加强免疫时血清阳性率仍为 1 0 0 % ,抗体 GMT为 2 36 .2m IU…     

乙型脑炎减毒活疫苗安全性和免疫原性观察

目的 观察乙型脑炎（乙脑）减毒活疫苗的接种反应和免疫原性.方法 分别选择52名（8月龄～50岁）和607名（8月龄～12岁）健康志愿者进行Ⅰ和Ⅲ期临床试验.试验组每人接种1次由上海生物制品研究所有限责任公司研制的乙脑减毒活疫苗（0.5 ml）,对照组接种同样剂量的已上市乙脑减毒活疫苗.两组接种后的不良反应率和中和抗体阳转率用x2检验进行比较,中和抗体几何平均滴度用t检验进行比较.结果 试验组接种后有5.91％的人体温升高,对照组为7.96％,两组的体温反应发生率差异无统计学意义（x^2 =0.917,P=0.338）.试验组Ⅰ期试验局部反应率为1.92％,Ⅲ期试验为0.25％,对照组Ⅲ期试验局部反应率为0.50％,两组的局部反应率差异无统计学意义（确切概率法,P=0.553）.Ⅲ期免疫原性试验中,试验组的血清中和抗体阳转率为89.00％,抗体几何平均滴度为29.69;而对照组分别为74.59％和19.25,差异均有统计学意义（x^2=11.708,P=0.001;t=4.281,P=0.001）.结论 本研究的试验性乙脑减毒活疫苗接种反应轻微,并具有良好的免疫原性.     

用浓缩纯化森林脑炎灭活疫苗免疫供血者制备免疫制剂

为了选择制备抗森林脑炎病毒的高度特异性免疫球蛋白和血浆的最适宜条件,作者采用3组不同疫苗,以不同注射途径、不同剂量和不同免疫间隔,共接种20～50岁成人供血者844人,其血清用血凝抑制或中和试验测定抗体滴度,用小鼠检查免疫球蛋白的抗病毒作用。结果表明,加氢氧化铝吸附剂的浓缩森林脑炎疫苗组,皮下免疫3针、间隔3～4周或免疫2针、间隔6个月,其血凝抑制抗体阳转率为72～76%,抗体几何平均滴度(GMT)为1:26～1:54,而同组疫苗免疫2针、间隔4周,其抗体阳转率只有58%。不加吸附剂的浓缩森林脑炎疫苗组,肌肉注射0.5ml 2针、间隔6个月,其抗体阳转率     

福马林灭活甲型肝炎疫苗在儿童中的安全性、耐受性和免疫原性

作者将感染28代CR326F甲型肝炎病毒（HAV）的MRC与细胞采用转瓶培养机械收获或在丹麦Nnuc细胞工厂培养,与含去污剂的缓冲液接触收获来纯化HAN,并用福马林灭活制成3批氢氧化铝佐剂HAV疫苗。将美国肯塔基州150名4～12岁健康农村儿童随机分为三组,免疫程序为0和24周。A和B组分别接种来自两批转瓶培养的疫苗,肌肉注射12单位（A组）或25单位（B组）;C组接种丹麦细胞工厂制备的疫苗25单位（相当于400ng病毒蛋白）。于接种前3周和第1剂接种后4,24,28周采血,用改良的HAVAB Ab-bott试验检测各组血清抗HAV抗体。 结果显示,接种后4周,99％抗HAV抗体阳转,28周后100％阳转。4、24和28周的抗体几何平均滴度（GMT）分别为31～49、51～79和7059～29609mIU/ml。另外,28周时C组的抗体GML比B组高3倍。A和C组接种后4周有93％可检出中和抗体。接种后不良反应包括一半儿童出现注射局部轻微反应,全身反应以头痛为主,但很轻微。实验室异常少见,轻微且无临床意义,三组间无差异。 作者认为用上述两种方法培养细胞生产出的HAV疫苗的免疫原性有较大差异的原     

鹰潭市2004-2006年人用狂犬病疫苗接种效果分析

目的 了解2004-2006年间鹰潭市民被狗、猫、鼠等动物咬、抓伤后接种狂犬病疫苗的效果.   方法   对被动物咬、抓伤者全程接种狂犬病疫苗后15～20 d以ELlSA方法测定血清抗狂犬病抗体.   结果 在全程接种狂犬病疫苗的961名被动物咬、抓伤者中,抗体阳性893人,阳性率为92.9%.≥60岁组与＜60岁组间的抗体阳性率差异有统计学意义(X2=5.716,P＜O.01).   结论   被动物咬、抓伤者及时接种狂犬病疫苗是控制狂犬病的重要手段.     

Antibody responses to recombinant, yeast-derived hepatitis B vaccine in teenage New Zealand children

Three groups of healthy teenage New Zealand children were given 2.5 micrograms, 5 micrograms and 10 micrograms, which is the currently recommended dose, of Merck Sharp and Dohme recombinant yeast-derived hepatitis B vaccine at time 0, 1 and 6 months and tested for antibody responses to vaccine and for other hepatitis B virus markers. Seroconversion rates exceeded 98% in all three groups. Geometric mean titres (GMT) of the anti-HBs increased with higher doses. There was no significant differences in GMT between the sexes. Under the conditions of this study, 2.5 micrograms doses of this vaccine induced an excellent antibody response in children 12-14 years of age.     

Response to Hepatitis A Vaccine in Children after a Single Dose with a Booster Administration 6 Months Later

Background: Children are of an age group susceptible to infection by the hepatitis A virus (HAV). Active immunization of children against HAV became reality in 1993, when the first pediatric hepatitis A vaccine was licensed. This initial vaccine required two injections to induce a full immune response in recipients. The purpose of this study was to assess the feasibility of a single dose primary vaccine plus a booster after 6 months against hepatitis A in children.
Methods: A total of 60 healthy and seronegative children between 2 and 13 years of age were administered inactivated hepatitis A vaccine, containing 720 enzyme-linked immunosorbent assay (ELISA) units (EL.U) of hepatitis A antigen, intramuscularly in the deltoid region at months 0 and 6. Symptoms were recorded by parents or guardians on individual diary cards. Antibodies against HAV (antiHAV) were measured using an ELISA inhibition assay, and a seropositive titer was defined as being ≥20 mIU/mL.
Results: Fifteen days after the single primary dose, 96% of the vaccinees were seropositive with a geometric mean titer (GMT) of 351 mIU/mL The seropositivity rate reached 100% 1 month after the first dose, with a GMT of 305 mIU/mL Prior to the second dose at month 6, 93% remained seropositive, and the GMT was 153 mIU/mL. By month 7, 1 month after the second vaccination, the seropositivity rate recovered to 100% with a rise in GMTs to 3644 mIU/mL. Local symptoms were reported after 23.9% of doses, and general symptoms after 19.7% of doses. All symptoms were of short duration and resolved spontaneously.
Conclusions :This inactivated vaccine against hepatitis A is safe, well-tolerated, and excellently immunogenic when administered to children following a single dose plus booster course at months 0 and 6.     

Prevalence of hepatitis B in children in a high risk New Zealand community, and control using recombinant DNA vaccine

Two hundred and sixty-six children aged 3-10 years were tested for hepatitis B virus (HBV) serologic markers. Thirty-eight were positive, including seven who were positive for hepatitis B surface antigen (HBsAg). Two hundred and fifteen healthy children were randomised to receive either 3 x 5 micrograms doses or 3 x 10 micrograms doses of Smith Kline Biologicals Engerix B recombinant DNA (rDNA) hepatitis B vaccine into the deltoid muscle at 0, 1 and 6 months. They were tested for seroconversion and levels of antibody to hepatitis B surface antigen (anti-HBs) one month after dose 3. Ninety-nine percent of children in each group seroconverted for anti-HBs. Geometric mean titres (GMT) or anti-HBs in IU/L were higher with 10 micrograms doses. Nevertheless, 3 x 5 micrograms is the appropriate regimen for protecting children in this age group, as long as cost of vaccine remains a major factor in immunisation programmes.     

宝安区6~15岁在校儿童高浓度麻疹IgG抗体影响因素研究

目的研究分析宝安区6~15岁在校儿童高浓度麻疹免疫球蛋白G(IgG)抗体影响因素。方法研究共调查宝安区6~15岁在校儿童444例,均采集静脉血1 ml,分离血清并进行麻疹IgG抗体的定量酶联免疫吸附试验(ELISA)检测,并对高浓度麻疹IgG抗体影响因素进行单因素及多因素分析。结果单因素分析结果显示:年龄、父亲文化程度、母亲文化程度、麻疹疫苗接种剂次、首针接种月龄是6~15岁在校儿童高浓度麻疹IgG抗体的影响因素,差异有统计学意义(P<0.05)。多因素Logistic回归分析结果显示,年龄、首针接种月龄为6~15岁在校儿童高浓度麻疹IgG抗体的主要危险因素,差异具有统计学意义(P<0.05)。结论儿童麻疹发病的预防控制,对于麻疹疫苗首剂的接种,可以考虑将首剂接种月龄延后,以提高疫苗的效力。对于该年龄段的儿童可以考虑结合实际情况,适时进行加强免疫。     

Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine

To monitor immune status during clinical trials and after vaccine registration, several assays have been developed to measure type-specific human papillomavirus (HPV) serum antibody levels. These include neutralization assays, single epitope-based inhibition immunoassays, and direct enzyme-linked immunosorbent assays (ELISAs). Neutralization assays based on multiple epitopes and independent of vaccine material are considered the 'gold standard' for unbiased assessment of the protective potential of vaccine-induced antibodies. However, their use in large clinical trials is challenging. Here, we compare both the direct ELISA and the single epitope-based inhibition ELISA with the pseudovirion-based neutralization assay (PBNA) for HPV-16/18 antibody responses in vaccinated women enrolled in trials of Cervarix, GSK's cervical cancer vaccine. The direct ELISA, which is based on multiple epitopes, was shown to have a higher degree of sensitivity and correlation with the PBNA when compared with the single epitope-based inhibition ELISA. Among double-positive results, high correlations were observed between the PBNA and the direct ELISA (0.70-0.88 for HPV-16 and 0.82-0.94 for HPV-18) and also with the single epitope-based inhibition ELISA (0.60-0.89 for HPV-16 and 0.57-0.96 for HPV-18) in women aged 15-25 years. The correlation persisted up to 6.4 years after primary vaccination. Similar levels of correlation were observed for adolescents aged 10-14 years and women aged 46-55 years. Therefore, the direct ELISA appears to be an excellent surrogate for neutralizing activity and can be used to evaluate antibody response induced by L1 virus-like particle-based cervical cancer vaccines, regardless of time elapsed after vaccination (up to 6.4 years) and the age of the vaccine recipient.     

安徽省2011年0～6岁儿童抗百日咳毒素抗体水平监测

 目的  了解安徽省≤6岁健康儿童抗百日咳毒素（pertussis toxin,PT）抗体水平,为评价疫苗接种效果提供依据。 方法   采用多阶段随机抽样方法,在全省16个市0～6岁7个年龄组人群中抽取健康儿童1 787人,用ELISA定量检测血清抗PT IgG抗体。各组之间抗体阳性率差异比较采用χ²检验,抗体几何平均浓度（GMC）差异比较采用F检验。结果   2011年安徽省0～6岁儿童中,几乎所有采集的血清均呈现不同的抗体水平,以0岁组最高（10.33 IU/ml）。抗体GMC随免疫后时间的延长有下降的趋势。不同年龄组之间抗体阳性率和GMC差异均有统计学意义（χ²=15.06,P＜0.05;F=7.96,P＜0.01）。不同性别之间抗体阳性率和GMC差异均无统计学意义（χ²=0.98,P＞0.05;Z=0.852,P=0.394）。 结论   安徽省0～6岁儿童抗PT IgG抗体水平随年龄的增加而降低,是否需要加强免疫需作进一步研究。     

Seroprevalence of anti Vi antibodies and immunogenicity of Typhim Vi vaccine in children

This prospective study was carried out on 250 children between 6 months to 5 years of age to determine seroprevalence of anti Vi antibodies and to measure seroresponse and percent seroconversion to TyphimVi polysaccharide vaccine in children 2-5 years of age. Fifty children each were enrolled between 6 to 12 months of age (Group A), between 1- 2 years of age(Group B), between 2-3 years of age (Group C), between 3-4 years of age (Group D) and between 4-5 years of age (Group E). Anti-Vi antibody baseline titres were determined in all children. Children in Groups C to E were vaccinated with Typhim Vi vaccine. Baseline and postvaccination antibody titres were determined by ELISA. Test sera which had antibody levels >1 microg/ml were scored as seropositive. Of 250 children, 3 had base line anti-Vi antibodies >1 microg/ml. Following immunization overall seroconversion rate was 77.5% with 65.3%, 78.2% and 88% children showing seroconversion in Groups C, D and E respectively. Seroconversion was significantly more in Group E children compared to Group C (p=0.0148). There were no significant adverse reactions following vaccination. The study highlights very low prevalence of baseline anti Vi antibodies in children between 6 months and less than 5 years of age and shows high immunogenicity and safety of Typhim Vi polysaccharide vaccine in children 2-5 years of age.     

Concomitant administration of zoster and pneumococcal vaccines in adults ≥60 years old

This study evaluated safety & immunogenicity of ZOSTAVAX? (zoster vaccine: ZV) administered concomitantly versus nonconcomitantly with PNEUMOVAX? 23 (pneumococcal vaccine: PPV23). This randomized, double-blind, placebo-controlled study enrolled 473 subjects ≥60 years old in 1:1 ratio to receive ZV & PPV23 concomitantly (Day 1) or nonconcomitantly (PPV23 Day 1, ZV Week 4). Blood samples obtained for pneumococcal polysaccharide (PnPs) antibody (Ab) testing by enzyme-linked immunosorbent assay (ELISA) and varicella-zoster virus (VZV) Ab testing by glycoprotein ELISA. Subjects followed for adverse experiences (AEs) for 28 days postvaccination. Mean baseline VZV geometric mean titers (GMT) in nonconcomitant group were lower than concomitant group. Four weeks postvaccination with ZV, VZV Ab response in concomitant group was not similar to nonconcomitant group; estimated VZV GMT ratio [concomitant/nonconcomitant] was 0.70 (95% CI, 0.61-0.80). VZV Ab response was acceptable in concomitant group; estimated geometric mean foldrise (GMFR) from baseline was 1.9 (95% CI, 1.7-2.1). PnPs serotype-specific Ab responses were similar in both groups. All 6 reported serious AEs were deemed not related to study vaccine. Postvaccination of ZV, incidence of injection-site AEs was similar in both groups; clinical AEs were numerically but not significantly higher in nonconcomitant group. In summary, VZV GMT Ab response induced by ZV administered concomitantly with PPV23 was inferior to that induced nonconcomitantly. These results indicate that, to avoid a potential decrease in ZV immunogenicity, ZV & PPV23 should not be given concomitantly. Concomitant administration did not affect response to PPV23 serotypes tested. When administered concomitantly, ZV & PPV23 vaccines were generally well tolerated.     

血清抗风疹IgG抗体检测方法的比较研究

目的  比较微量血凝抑制 （micro-hemagglutination inhibition,HI）试验与酶联免疫吸附测定（enzyme-linked immunosorbent assay,ELISA）检测血清抗风疹IgG抗体的敏感性和特异性,确定ELISA法检测血清抗风疹IgG抗体的可行性。方法  采集江苏地区506名8~15月龄健康儿童免疫前和麻疹-腮腺炎-风疹联合疫苗免疫后1个月的血清,共1012份血清,分别采用HI法和ELISA法检测血清抗风疹IgG抗体,并采用卡方检验对两种方法的检测结果进行比较。结果  HI法和ELISA法的血清抗风疹抗体阳性检出率分别为50.30%和47.33%,两种方法的阳性检出率之间的差异无统计学意义（χ²=1.780,P=0.182）。两种方法检出同为阴性的血清495份,同为阳性的血清476份血清,两种方法的检测符合率为95.95%。相关与回归分析显示,两种方法具有高度的正相关性（r=0.806,P＜0.001）。结论  可用ELISA法替代HI法进行血清抗风疹IgG抗体检测。