Can Haemophilus influenzae type b-tetanus toxoid conjugate vaccine be combined with diphtheria toxoid-pertussis vaccine-tetanus toxoid?

OBJECTIVE: To assess the side effects and immune responses after three serial doses of PRP-T vaccine (a Haemophilus influenzae type b [Hib]-tetanus toxoid conjugate vaccine) given concurrently or mixed with adsorbed DPT vaccine (diphtheria toxoid-pertussis vaccine-tetanus toxoid). DESIGN: Multicentre randomized controlled trial. SETTING: Four public health units in western Canada. PARTICIPANTS: Healthy infants 8 to 15 weeks old at entry who were able to receive routine primary vaccinations. Of 444 infants enrolled, 433 (98%) completed the study. INTERVENTIONS: All infants received PRP-T and DPT vaccines at 2, 4 and 6 months of age: half received them mixed in one injection and the others as separate, bilateral injections. MAIN OUTCOME MEASURES: Side-effects 24 and 48 hours after each dose and serologic responses to each vaccine component. RESULTS: Follow-up was obtained after all 1312 vaccinations. Fever was infrequent in the two treatment groups. Local adverse effects of the PRP-T vaccine were infrequent and mild (e.g., redness was noted in 5.9% of cases and the area of redness was more than 2.5 cm in diameter in 0.8%). The incidence rate of local effects of the DPT-containing vaccines was the same in the two groups except for tenderness, which was more frequent in the group given the mixed vaccine (26.6% v. 17.9%, p < 0.001). Serologic data were available for 97% of the subjects. After the three doses 98.1% of the subjects had a PRP antibody level of 0.15 micrograms/mL or more, and 87.9% had a level of 1.0 micrograms/mL or more, both levels compatible with protection against Hib. Responses to PRP-T were comparable between the treatment groups as were responses to the diphtheria and tetanus toxoids. Pertussis agglutinin titres were reduced after administration of one of two PRP-T lots mixed with DPT vaccine, but responses to four other pertussis antigens were not impaired. CONCLUSION: PRP-T vaccine is well tolerated and immunogenic. Combined PRP-T and DPT vaccines performed satisfactorily and may be the preferred method of administration.     

不同剂量重组乙肝疫苗的免疫效果评价

目的：了解不同剂量重组（酵母）乙肝疫苗和重组（CHO）乙肝疫苗在大学生中的乙肝病毒表面抗体（抗-HBs）应答,为成人乙肝疫苗接种剂量的确定提供依据。方法： 238例新入校大学生随机分为4组,按照0、1和6个月免疫程序分别接种两种不同剂量(酵母)乙肝疫苗和(CHO)乙肝疫苗,全程免疫后1个月,检测血清抗-HBs阳转率和抗-HBs平均几何滴度（GMT）,同时观察4组的不良反应。结果： 接种10 μg(酵母)乙肝疫苗组、10 μg(CHO)乙肝疫苗、20 μg(CHO)乙肝疫苗及20 μg(酵母)乙肝疫苗组的抗-HBs 阳转率分别为98.3%、95.0%、96.7%及96.5%,4组重组乙肝疫苗的抗-HBs阳转率之间比较差异无显著性 (χ²=1.034,P>0.05);4组疫苗之间抗-HBs GMT比较差异有显著性（Kruskal-Wallis χ² =18.301,P<0.05）,其中10 μg（酵母）乙肝疫苗组的抗-HBs GMT高于10 μg（CHO）乙肝疫苗组(P<0.05);2种20 μg乙肝疫苗组之间的抗-HBs GMT比较差异无显著性(P>0.05);20 μg(CHO)乙肝疫苗组的抗-HBs GMT高于10 μg组 (P<0.05); 10 μg与20 μg（酵母）乙肝疫苗组抗-HBsGMT比较差异无显著性（P>0.05)。男女性别间不同剂量乙肝疫苗抗-HBs GMT比较差异无显著性(Mann-Whitney U=6 512.000,P>0.05)。未发现明显的不良反应。结论： 重组乙肝疫苗对成人具有较好的免疫原性和安全性,建议成人接种10 μg重组乙肝疫苗。     

Role of whole-cell pertussis vaccine in severe local reactions to the preschool (fifth) dose of diphtheria-pertussis-tetanus vaccine.

OBJECTIVE: To estimate the contribution of whole-cell pertussis vaccine to severe local reactions after the preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus toxoid (DPT) vaccine. DESIGN: Double-blind randomized controlled trial. SETTING: Urban community. PARTICIPANTS: Volunteer sample of 200 healthy children 4 to 6 years old who were eligible for the fifth dose of DPT vaccine. INTERVENTIONS: Children received, in both arms, either diphtheria toxoid-tetanus toxoid (DT) and monovalent pertussis vaccines (group A, 99 children) or DPT and meningococcal vaccines (group B, 101 children). All were licensed products from single lots. The children were assessed 24 hours later by a trained observer. Serum samples obtained before vaccination were tested for antibodies to tetanus and diphtheria toxins and five pertussis antigens by means of enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES: Rates of severe local reactions (an area of redness or swelling or both of 50 mm or greater) 24 hours after vaccination. Relation between serum antibody levels before vaccination and rates of severe local reactions to corresponding vaccines. RESULTS: All of the subjects were followed up 24 hours after vaccination. Severe redness was present in 38% given DPT vaccine, 29% given intramuscular pertussis vaccine and 9% given DT vaccine (p < or = 0.002, three-way comparison). Severe swelling was common after vaccination with all three products. After intramuscular pertussis vaccination a relation was evident between the prevaccination levels of antibody to whole-cell pertussis bacteria and the rates of redness (p < 0.02) but not between the prevaccination subcellular antibody levels and the rates of redness. CONCLUSION: That pertussis vaccine resembled the DPT vaccine in causing severe redness suggests that it is the principal cause of such reactions after DPT vaccination. The DT vaccine was also reactogenic; thus, cumulative sensitization to one or more of its constituents may be a factor.     

Combined tetanus, diphtheria, and 5-component pertussis vaccine for use in adolescents and adults

Context  Increasing reports of pertussis among US adolescents, adults, and their infant contacts have stimulated vaccine development for older age groups. Objective  To assess the immunogenicity and reactogenicity of a tetanus-diphtheria 5-component (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) acellular pertussis vaccine (Tdap) in adolescents and adults. Design, Setting, and Participants  A prospective, randomized, modified double-blind, comparative trial was conducted in healthy adolescents and adults aged 11 through 64 years from August 2001 to August 2002 at 39 US clinical centers. Interventions  A single 0.5-mL intramuscular dose of either Tdap or tetanus-diphtheria vaccine (Td). Main Outcome Measures  Antibody titers to diphtheria and tetanus toxoids for Tdap and Td were measured in sera collected from subsets of adolescents and adults, before and 28 days after vaccination. For pertussis antigens, titers in sera from Tdap vaccinees were assessed vs those from infants who received analogous pediatric diphtheria-tetanus-acellular pertussis vaccine (DTaP) in a previous efficacy trial. Safety was assessed via solicited local and systemic reactions for 14 days and adverse events for 6 months following vaccination. Results  A total of 4480 participants were enrolled. For both Tdap and Td, more than 94% and nearly 100% of vaccinees had protective antibody concentrations of at least 0.1 IU/mL for diphtheria and tetanus, respectively. Geometric mean antibody titers to pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3 exceeded (by 2.1 to 5.4 times) levels in infants following immunization at 2, 4, and 6 months with DTaP. The incidence of solicited local and systemic reactions and adverse events was generally similar between the Tdap and Td groups. Conclusions  This Tdap vaccine elicited robust immune responses in adolescents and adults to pertussis, tetanus, and diphtheria antigens, while exhibiting an overall safety profile similar to that of a licensed Td vaccine. These data support the potential routine use of this Tdap vaccine in adolescents and adults.      

Estimated effects of a delay in the recommended vaccination schedule for diphtheria and tetanus toxoids and pertussis vaccine

The occurrence of adverse events temporally associated with diphtheria and tetanus toxoids and pertussis vaccine (DTP) has led to consideration of a delay in the schedule of initial vaccination. We developed an inferential model estimating the changes in pertussis- and DTP-associated health outcomes that might occur if initial DTP administration were delayed from 2, 4, and 6 months to 8, 10, and 12 months of age. An additional 636 cases of pertussis--115 of which would be associated with complications, including two encephalopathies--were projected to occur under the proposed as compared to the current schedule. Adverse medical events attributable to the vaccine were assumed to remain unchanged following the change in schedule. We projected 353 fewer chance associations with sudden infant death syndrome but 1311 more chance associations between DTP and seizures. These estimates suggest that the current schedule of vaccinating infants at 2, 4, and 6 months of age is casually associated with less morbidity and should be continued.     

甲型肝炎减毒活疫苗与灭活疫苗免疫效果的比较

目的 观察甲型肝炎（甲肝）减毒活疫苗Ｈ２株与ＬＡ－１株的不同剂量、不同免疫程序的免疫原性及抗体动脉变化。方法 在河北、广西两地５选择３１８名经甲肝抗体检测为阴性的易感儿童,按不同剂量程序及不同甲肝疫苗,分为６组,并在首剂接种后１、６、７、１２、１３月份分别采集血清标本,检测甲肝总抗体。结果 各组抗体水平均于再免疫后１个月达高峰,以后开始下降,再免半年后抗体水平仍明显高于初免抗体水平;灭活于再免疫后     

新兵接种乙型肝炎疫苗快速免疫程序和两针免疫程序的效果比较

目的: 研究新兵采用快速免疫程序或两针免疫程序的免疫效果,为丰富军人乙肝免疫策略提供依据.方法: 150名符合要求的新兵随机分为A,B,C三组,分别按标准免疫成序、快速免疫程序、两针免疫程序接种乙肝疫苗,每次均为10 μg.结果: 首针免疫后1 mo时B组的血清抗-HBs阳转率(64.0%)高于A组(26.0%,P<0.01)和C组(28.0%,P<0.01),首针免疫7 mo和12 mo时三组间抗-HBs阳性率无显著性差异(P>0.05);同时,首针免疫后1 mo时,B组的抗-HBs几何平均滴度(GMT)高于A组和C组(P<0.01),3 mo时,B组的抗-HBs几何平均滴度仍高于A组和C组(P<0.01),7 mo时A组的抗-HBs几何平均滴度高于B组和C组(P<0.01).结论: 和标准免疫程序相比,快速免疫程序能较早地产生保护性抗体,两针免疫程序经济、有效,依从性好.     

Avidity and bactericidal activity of antibody elicited by different Haemophilus influenzae type b conjugate vaccines. The Vaccine Study Group.

OBJECTIVE--Antibody avidity is a measure of the functional affinity of serum antibody to bind to antigen. In this study, we compared the avidity of antibodies elicited by vaccination with three Haemophilus influenzae type b (Hib) conjugate vaccines and investigated the relationship between antibody avidity and the ability of antibody to activate complement-mediated bactericidal activity. DESIGN--A convenience sample of 171 postvaccination serum samples with more than 0.5 microgram/mL of anticapsular antibody, the minimum concentration required for measurement of avidity. The serum samples were obtained from infants participating in immunogenicity trials with Hib capsular polysaccharide (PRP) conjugated to meningococcal outer membrane protein complex (PRP-OMPC) or to tetanus toxoid (PRP-T), or PRP oligomers conjugated to a nontoxic mutant diphtheria toxin, CRM197 (Oligo-CRM). PATIENTS--Healthy infants recruited in private practices. PRIMARY OUTCOME MEASURES--Avidity of vaccine-induced serum anticapsular antibody and serum bactericidal titers. RESULTS--In infants vaccinated at 2, 4, and 6 months of age, Oligo-CRM evoked antibody of higher avidity than PRP-OMPC (P less than .001). The mean avidity of antibody elicited by PRP-T was intermediate, being lower than Oligo-CRM (P less than .02) but higher than PRP-OMPC (P = .001). Also, after one dose, 18-month-old infants given Oligo-CRM had higher avidity antibodies compared with those given PRP-OMPC (P less than .001). Half of the infants in both age groups who were given Oligo-CRM developed antibody avidity of 2.50 nM-1 or greater, whereas more than two thirds of the infants given PRP-OMPC had avidity values of 1.25 nM-1 or less. Antibodies with avidity of 1.25 nM-1 or less were, on average, 6.6-fold less active in assays of complement-mediated bactericidal activity than antibodies with avidity of 2.50 nM-1 or greater (P less than .001). CONCLUSIONS--Oligo-CRM and PRP-T conjugate vaccines elicit higher avidity antibody than PRP-OMPC, and high-avidity antibody is more potent than low-avidity antibody in serum bactericidal assays. Consideration should be given to including measurement of antibody avidity in assessment of new vaccines since avidity may affect the ability of serum antibody to confer protection against disease.     

肾综合征出血热患者病后和人群疫苗接种后远期免疫学效果研究

目的 了解肾综合征出血热(HFRS)疫苗接种人群和HFRS患者病后的远期(5年以上)免疫学效果。方法 采用间接免疫荧光试验(IFAT)检测血清HFRS特异性IgG抗体，1：20为阳性。对接种组人群抗体滴度＜1：320者，强化免疫1针，15d后静脉采血，同样方法检测IgG抗体。结果接种组人群95例，抗体阳性率100％，GMT40．29；强化免疫人群59例，GMT71．13；疫苗接种组人群在强化免疫前后GMT有显著性差异(P＜0．01)。HFRS患者55例，抗体阳性率100％，GMT97．87；疫苗接种与否对患者病后的血清特异性IgG抗体水平无显著影响。近9年免疫人群的年发病率为16．38／10万，对照人群为73．92／10万，年均保护率77．84％。结论 HFRS疫苗的远期免疫学和流行病学效果较好；HFRS患者病后具有较持久的免疫力。     

全病毒流感灭活疫苗免疫效果及接种反应观察

目的:为了解国产长生公司全病毒流感灭活疫苗免疫效果及接种反应情况,以评价该公司产品质量。方法:分三年龄组分别采集13～18岁42名,19～59岁33名,60岁以上30名人群免前及免后21天血进行血清血凝抑制(HI)抗体检测,并同时于接种后24小时、48小时、72小时调查调查人群接种反应情况(包括体温、局部红晕、全身症状)结果:105名被调查人群H1N1型阳转率85.7%(90/105),保护率94.3%(99/105),GMT增长倍数18.26;H3N2型阳转率45.7%(48/105),保护率100%(105/105)GMT增长倍数2.37;B型阳转率62.9%(66/105),保护率48.6%(51/105),GMT增长倍数4.81;各年龄组H1N1型阳性率均高于其他两型,而各年龄组H1N1、H3N2型保护率均较高,B型较低。13～18岁,19～59岁H3N2型GMT增长倍数较低,其他组别GMT增长倍数能达到有关标准。所有反应个例除一例局部反应红肿为2.5Χ5.0cm为中度反应,其他均为弱反应。各反应个例均于24小时内达高峰,48～72小时基本恢复。结论:本次疫苗接种对各年龄组人群免疫效果较理想,疫苗接种反应轻微且一过性。     

Live varicella vaccine in both immunocompromised and healthy children

BACKGROUND: There is no information on the use of live varicella vaccine in Mexican children. Our objective was to evaluate antibody response and safety of the live varicella vaccine in both healthy and immunocompromised Mexican children. METHODS: One hundred children with no history of varicella/zoster were vaccinated with a live attenuated varicella vaccine. According to their immune status, patients were divided into either a compromised (leukemia, solid tumors, chronic renal failure, and cirrhosis) or a healthy children group. Serum IgG antibodies against VZV were measured by ELISA at baseline and at 3 and 6 months after vaccination. RESULTS: A positive VZV-ELISA at baseline was detected in 36 of 67 (53.7%) immunocompromised children and in 22 of 33 (66%) healthy children. Among VZV-seronegative children, seroconversion at 6 months post-vaccination was observed in 90.3% of compromised children and in 100% of healthy children. Increases in serum antibody levels at 3 and 6 months post-vaccination was similar in both groups. VZV vaccine-related adverse reactions, mostly mild and local, were detected in 29% of the children. Three compromised children had a mild rash symptomatic of varicella after vaccination. CONCLUSIONS: About 50% of immunosuppressed children (mean age 8.8 +/- 3.6 years) with no varicella history were VZV-seronegative. Almost all of these compromised VZV-seronegative patients seroconverted 6 months after vaccine. In addition, antibody titers were similar in both compromised and healthy children.     

Protective efficacy of a whole cell pertussis vaccine

A trial of the efficacy of a plain whole cell pertussis vaccine was conducted in Sweden. In this non-blinded trial 525 infants aged 2 months who were born on days with an even number received three doses of vaccine one month apart and 615 infants of the same age who were born on days with an odd number were enrolled as controls. During the 18 months of follow up there were 55 cases of pertussis. The attack rate was 1.5% (8/525) among the vaccinated children and 7.6% (47/615) among the unvaccinated children (p less than 0.001). The estimated efficacy of the vaccine was 80% (95% confidence interval 58 to 90). The estimated efficacy of pertussis vaccine was similar to that observed in British trials over 30 years ago.     

Adverse events following pertussis and rubella vaccines. Summary of a report of the Institute of Medicine.

In August 1991, the Institute of Medicine released a report entitled Adverse Effects of Pertussis and Rubella Vaccines, which examined 18 adverse events in relation to diphtheria-tetanus-pertussis (DTP) vaccine and four adverse events in relation to the currently used rubella vaccine strain, RA 27/3. The committee spent 20 months reviewing a wide range of information sources, including case series and individual case reports, both published and unpublished, epidemiologic studies, studies in animals, and other laboratory studies. The committee found that the evidence indicates a causal relation between DTP vaccine and anaphylaxis and between the pertussis component of DTP vaccine and extended periods of inconsolable crying or screaming. The committee also reported that the evidence indicates a causal relation between the rubella vaccine and acute arthritis in adult women. The committee found the available evidence weaker but still consistent with a causal relation between DTP vaccine and two conditions--acute encephalopathy and hypotonic, hyporesponsive episodes--and between rubella vaccine and chronic arthritis in adult women. Estimated incidence rates of these adverse events following vaccination are provided, where possible. The committee found that the evidence does not indicate a causal relation between the DTP vaccine and infantile spasms, hypsarrhythmia, Reye's syndrome, and sudden infant death syndrome. The committee found insufficient evidence to indicate either the presence or absence of a causal relation between DTP vaccine and chronic neurologic damage, aseptic meningitis, erythema multiforme or other rash, Guillain-Barré syndrome, hemolytic anemia, juvenile diabetes, learning disabilities and attention-deficit disorder, peripheral mononeuropathy, or thrombocytopenia, and between rubella vaccine and radiculoneuritis and other neuropathies or thrombocytopenic purpura. The committee's evaluative methods are briefly described and a summary of research needs is provided.     

口服轮状病毒减毒活疫苗与麻疹－风疹联合减毒活疫苗联合接种的免疫原性和安全性研究

目的:探讨口服轮状病毒减毒活疫苗(oral live attenuated rotavirus vaccine,ORV)与麻疹-风疹联合减毒活疫苗(measles and rubella combined attenuated live vaccine,MR)联合接种的可行性,为制定免疫规划程序提供可靠的科学依据。方法:设两种疫苗同时接种组和单苗接种组,观察疑似预防接种异常反应(AEFI)发生情况,接种前后、联合接种与单独接种组之间抗体几何平均滴度/浓度(GMT/GMC)、抗体阳性率和阳转率的差异。结果:各接种组临床反应都轻微,实验组与各对照组免前免后同种抗体GMT/GMC、阳性率,以及免后抗体阳转率,其差异均无显著意义(P>0.05)。结论:ORV与MR同时接种未发现严重异常反应和相互干扰免疫应答,可以同时接种。     

132名低龄儿童应用甲型肝炎灭活疫苗初次免疫效果观察

目的 为了评价孩尔来福甲型肝炎灭活疫苗在本地区低龄儿童应用中的初次免疫效果。方法 对初次应用甲型肝炎灭活疫苗免疫的2～6岁甲肝易感儿童132人随机分成4组,观察初次免疫后局部反应和全身反应,检测免疫后1、3、6．7个月的血清抗甲肝病毒抗体（抗-HAV）阳转率和滴度（GUT）。结果 显示孩尔来福甲型肝炎无局部及全身反应,初次免疫后1、3、6、7个月抗-HAV阳转率分别为100％、97．83％、100％、100％,抗-HAV滴度分别为744．35mIU／ml、524．41mIU／ml、354．34mIU／ml、333．13mIU／ml。结论 各组之间差异无显著的统计学意义。表明孩尔来福甲型肝炎灭活疫苗在低龄儿童中应用是非常安全的;并且具有良好的免疫效果：儿童型每剂含病毒抗原250U,适用于儿童接种。     

Immunogenicity and safety of a new inactivated hepatitis A vaccine in young adults: a comparative study

目的：评价一种国产甲型炎灭活疫苗对我国成年人的免疫原性、安全性和适宜剂量。方法：104名甲肝抗体阴性、乙肝表面抗原阴性、血清谷丙转氨酶正常的成年志愿被随机分为三组：一组接种1000u的国产灭活疫苗,一组接种500u的国产灭活疫苗,另一组接种1440ELISAu的贺福立适甲肝灭活疫苗。所有三组均在初免后6个月时加强免疫一次。对三组间的局部和全身反应、血清甲且抗体阳转率以及抗体几何平均滴度（GMT）进行比较。结果：虽然贺福立适组在初免后局部反应销多,在初免和加强免疫后,三个组的局部和全身反应发生率基本相似。末观察到严重的局部和全身反应。初免后一个月时,1000u组的甲且抗体阳性率为87.5％,高于贺福立适组50.0％的抗体阳转率（P=0.001）;6个月时,1000u组的抗体阳转率为96.9％,高于500u组的65.0％（P=0.0029）和贺福立适组的68.8％（P=0.007）;7个月（加强免疫后一个月）时,所有接种对象全部阳转。三组在初免后一个月时,抗体GMT为264mIU/ml,高于贺福立适组的135mIU/l,（P=0.0013）;7个月时为2747mIU/ml,既高于贺福立适组的1316mIU/ml（P=0.01）,也高于500u组的167mIU/ml(P=0.0224)。结论：国产甲肝灭活疫苗免疫原性良好并且是安全性的,成人每次接种1000u,按0,6月程序接种可以提供很好的保护作用。     

热灭活疫苗HID39免疫小鼠可抵抗肺炎链球菌感染

目的 研制一种安全、有效且易于生产的肺炎链球菌疫苗,探讨其在BALB/c小鼠中的有效性.方法 通过热灭活肺炎链球菌标准菌株D39,得到无毒的、失去感染致病的能力的HID39,用HID39作为疫苗对随机分为阴性对照组(NC)、皮下免疫组(SC)和鼻内免疫组(IN)的小鼠进行免疫,ELISA法检测各组小鼠血清和唾液中的抗体...     

手足口病EV71型中和抗体变化的研究

目的评价手足口病(HFMD)患儿急性期和愈后的血清EV71型中和抗体变化。方法对安徽阜阳2008年4～8月因HFMD住院的患儿采集急性期和愈后1年血样,采用微量细胞病变中和试验方法检测EV71型中和抗体滴度。结果共调查到急性期组患儿83人和愈后1年组患儿57人。对这些病例的血清中和试验研究发现:急性期组和愈后组中和抗体阳性率差异分别为96.4%和82.5%,差异具有统计学意义(χ2=7.784,P<0.05)。急性期组和愈后组抗-EV71中和抗体GMT值分别为388.3和540.0,差异无统计学意义(t=0.907,P>0.05)。结论患儿愈后可以产生较高的抗-EV71中和抗体,且抗体可持续至少1年。     

Adverse reactions to the preschool (fifth) dose of adsorbed diphtheria-pertussis-tetanus vaccine in Canadian children.

OBJECTIVE: To quantify accurately the rate of adverse reactions after the preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus toxoid (DPT) vaccine and to test the hypothesis that large local reactions are attributable to the diphtheria toxoid. DESIGN: Double-blind randomized controlled trial. SETTING: Suburban community public health unit. PARTICIPANTS: Healthy children 4 to 5 years of age with a history of having received four doses of adsorbed DPT vaccine. INTERVENTIONS: Subjects were given either the standard DPT vaccine (with 25 Lf units of diphtheria toxoid) or a modified DPT vaccine (with 10 Lf units of diphtheria toxoid). They were assessed 24 hours later by a nurse. Serum samples obtained before vaccination were tested for diphtheria and tetanus antitoxin levels by means of neutralization assay and enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES: Rates of large local reactions (an area of redness or swelling or both of 5 cm or greater) 24 hours after vaccination in the two groups. Relation between serum antitoxin levels before vaccination and the rate of large local reactions in each group. RESULTS: Of the 250 subjects enrolled 124 received the standard vaccine and 126 the modified one. Large local reactions occurred in 71% of the subjects receiving the standard vaccine and 52% of those receiving the modified one (p less than 0.01). In the former group large erythematous reactions occurred significantly more often in those with an elevated prevaccination diphtheria antitoxin level than in those without an elevated level; no relation was found between such reactions and the prevaccination tetanus antitoxin level. Reduced arm movement was evident in 45% of the children in the two groups. Few had systemic adverse reactions. CONCLUSIONS: Large local reactions occur frequently after the preschool administration of the DPT vaccine. These reactions are uncomfortable but not serious. They result in part from the large amount of diphtheria toxoid in the standard DPT vaccine.     

儿童接种不同效价冻干麻疹减毒活疫苗的免疫效果研究

目的:采用不同滴度效价的冻干麻疹疫苗,对初次免疫儿童接种,为消除控制麻疹提供依据。方法:选择未接种过麻疹疫苗,未患过麻疹的健康儿童进行麻疹疫苗接种,并对其接种后的一般临床反应进行详细观察,同时对免前、免后血清抗体水平检测。结果:接种麻疹疫苗的婴儿一般临床反应轻微,发热率为5.7%;皮疹发生率为4.3%;局部反应为2.8%。采用ELISA方法检测IgG血清抗体,A组的血清抗体阳转率为95.23%,免疫成功率为86%;GMT值为1 364.22。B组的血清抗体阳转率达到了97.11%,免疫成功率86.13%;GMT值为1275.74。两组婴儿接种后血清抗体阳转率、免疫成功率以及GMT值组间差异性均无统计学意义(P>0.01)。结论:婴儿接种麻疹疫苗后,只要达到药典规定的滴度要求,就能获得良好的免疫应答效果。