BACKGROUND & AIMS: :In developing countries, risk of human papillomavirus (HPV) infection may be increased by the high prevalence of human immunodeficiency virus (HIV) infection. We evaluated the safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-infected women in South Africa. Asymptomatic HIV-positive women aged 18-25 years (N=120) were stratified by CD4⁺ T-cell count and randomised (1:1) to receive HPV-16/18 vaccine (Cervarix®; GlaxoSmithKline Vaccines) or placebo (Al[OH]3) at 0, 1 and 6 months (double-blind). HIV-negative women (N=30) received HPV-16/18 vaccine (open label). Anti-HPV-16/18 antibody and CD4⁺ T-cell responses, CD4⁺ T-cell count, HIV viral load, HIV clinical stage and safety were evaluated for 12 months. The safety and reactogenicity profile of the HPV-16/18 vaccine was comparable in HIV-positive and HIV-negative women. Irrespective of baseline HPV status, all HIV-positive and HIV-negative women who received the HPV-16/18 vaccine were seropositive for both HPV-16 and HPV-18 after the second vaccine dose (month 2) and remained seropositive for both antigens at month 12. Anti-HPV-16/18 antibody titres at month 12 remained substantially above levels associated with natural infection. The HPV-16/18 vaccine induced sustained anti-HPV-16/18 CD4⁺ T-cell responses in both HIV-positive and HIV-negative women. No impact of baseline CD4⁺ T-cell count or HIV viral load was observed on the magnitude of the immune response in HIV-positive women. In HIV-positive women, CD4⁺ T-cell count, HIV viral load and HIV clinical stage were unaffected by HPV-16/18 vaccine administration. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine appears immunogenic and well-tolerated in women with HIV infection. Study ID: 107863/NCT00586339.

背景与目标： ：在发展中国家，人乳头瘤病毒（HPV）感染的风险可能因人免疫缺陷病毒（HIV）感染的高流行而增加。我们评估了HPV-16 / 18 AS04佐剂在南非感染HIV的妇女中的安全性和免疫原性。将18-25岁（N = 120）的无症状HIV阳性女性按CD4⁺T细胞计数进行分层，并随机分配（1：1）接受HPV-16 / 18疫苗（Cervarix®; GlaxoSmithKline疫苗）或安慰剂（Al [OH] 3）在第0、1和6个月（双盲）。 HIV阴性妇女（N = 30）接受了HPV-16 / 18疫苗（开放标签）。评估12个月的抗HPV-16 / 18抗体和CD4βT细胞反应，CD4βT细胞计数，HIV病毒载量，HIV临床分期和安全性。 HPV-16 / 18疫苗的安全性和反应原性在HIV阳性和HIV阴性的妇女中相当。不论基线HPV状况如何，所有接受HPV-16 / 18疫苗的HIV阳性和HIV阴性妇女在第二剂疫苗（第2个月）后均对HPV-16和HPV-18呈血清阳性，而对两种抗原仍呈血清阳性在第12个月时，抗HPV-16 / 18抗体滴度在第12个月时仍显着高于与自然感染有关的水平。 HPV-16 / 18疫苗可在HIV阳性和HIV阴性的女性中诱导持续的抗HPV-16 / 18CD4βT细胞应答。没有观察到基线CD4⁺T细胞计数或HIV病毒载量对HIV阳性妇女的免疫反应程度有影响。在HIV阳性妇女中，HPV-16 / 18疫苗接种不会影响CD4⁺T细胞计数，HIV病毒载量和HIV临床分期。总之，HPV-16 / 18 AS04佐剂疫苗在具有HIV感染的女性中具有免疫原性和良好的耐受性。研究ID：107863 / NCT00586339。

BACKGROUND & AIMS: :Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7-21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.

背景与目标： ：腺病毒血清型4（ADV-4）和7（ADV-7）是美军新兵发热性急性呼吸道疾病（ARD）的重要原因。有效控制与腺病毒相关的ARD的先前许可的疫苗不再可用。在2004年秋季，我们进行了这一新的生产商生产的口服ADV-4和ADV-7活疫苗的1期随机，双盲，安慰剂对照试验，以评估其安全性和免疫原性。腺病毒疫苗以单剂量口服给予三十名受试者。另外的二十八名受试者接受了安慰剂。然后观察对象8周。最常见的不良反应是鼻充血（33％），咳嗽（33％），喉咙痛（27％），头痛（20％），腹痛（17％），关节痛（13％），恶心（13％） ）和腹泻（13％）。这些比率均与安慰剂无显着差异。疫苗病毒粪便脱落的持续时间为7-21天。到第28天时，有73％的疫苗接受者血清转化为ADV-4（GMT 23.3），而63％的患者血清转化为ADV-7（GMT 51.1）。研究人群。关于安全性和有效性的扩大试验正在进行中。

BACKGROUND & AIMS: Five triple-plaque purified vaccinia virus (VV) lines generated from smallpox Sevac VARIE vaccine (strain Praha) and three VV virus lines similarly derived from Wyeth DRYVAX vaccine were used for preparation of recombinants expressing the hepatitis B virus preS2-S gene. The same five Praha-derived virus lines were used to construct recombinants expressing the varicella-zoster virus (VZV) glycoprotein I (gpI) gene. Recombinants and their parental viruses were tested for the residual neurovirulence in mice. The virus lines and the recombinants derived therefrom differed markedly in this respect. Immunization of mice resulted in high levels of anti-HBsAg antibodies only in the case of recombinants derived from the relatively virulent viruses. In contrast, the levels of VZVgpI antibodies in mice were similar with all VV-VZV recombinants irrespective of the virulence of the parental virus line.

背景与目标： 从天花Sevac VARIE疫苗（Praha株）产生的五个三斑纯化牛痘病毒（VV）系和类似地从惠氏DRYVAX疫苗衍生的三个VV病毒系用于制备表达乙型肝炎病毒preS2-S基因的重组体。使用相同的五个Praha衍生病毒系构建表达水痘带状疱疹病毒（VZV）糖蛋白I（gpI）基因的重组体。测试重组体及其亲本病毒在小鼠中的残留神经毒力。在这方面，病毒系和由其衍生的重组体明显不同。小鼠的免疫仅在衍生自相对强毒的病毒的重组体的情况下才产生高水平的抗-HBsAg抗体。相反，不管亲本病毒系的毒性如何，所有VV-VZV重组子在小鼠中的VZVgpI抗体水平都相似。

BACKGROUND & AIMS: :The allergic response to small chemically inert molecules in thought to require their enzymatic conversion to reactive metabolites which are then endowed with the capacity to bind covalently to host proteins and produce immunogenic hapten-carrier conjugates. In contrast to previous studies in which hapten-carrier conjugates have been generated following chemical modification of drugs we have examined the immunogenicity of paracetamol following direct conjugation to carrier proteins with horseradish peroxidase (HRP). Highly substituted conjugates of paracetamol with keyhole limpet haemocyanin (KLH) or bovine serum albumin (BSA) were generated using HRP. The KLH conjugate was used to immunize Balb/C mice. IgM and IgG (predominantly IgG1) responses were observed and shown by enzyme-linked immunosorbent assay (ELISA) to be hapten-specific. Manipulations of HRP levels permitted substitution of KLH to varying extents with paracetamol. Such conjugates were tested for their ability to induce a hapten-specific immune response. It was determined that substitution of 1 mol of KLH with 700 mol of paracetamol was sufficient to generate an anti-hapten response. These data suggest a mechanism by which protein-non-reactive drugs may be rendered immunogenic and provide a method for demonstrating the presence of serum antibodies reactive with drug metabolites.

背景与目标： ：对化学惰性小分子的过敏反应被认为需要将其酶促转化为反应性代谢产物，然后赋予其与宿主蛋白共价结合并产生免疫原性半抗原-载体缀合物的能力。与先前的研究相反，在先前的研究中，化学修饰药物后已生成半抗原-载体偶联物，我们检查了与辣根过氧化物酶（HRP）直接偶联至载体蛋白后对乙酰氨基酚的免疫原性。使用HRP生成对乙酰氨基酚与匙孔血蓝蛋白（KLH）或牛血清白蛋白（BSA）的高度取代的共轭物。 KLH偶联物用于免疫Balb / C小鼠。观察到IgM和IgG（主要是IgG1）反应，并通过酶联免疫吸附测定（ELISA）显示为半抗原特异性。 HRP水平的操作允许用扑热息痛在不同程度上替代KLH。测试了此类缀合物诱导半抗原特异性免疫反应的能力。已确定用700摩尔对乙酰氨基酚取代1摩尔KLH足以产生抗半抗原反应。这些数据提示了使蛋白非反应性药物具有免疫原性的机制，并提供了证明与药物代谢物具有反应性的血清抗体的存在的方法。

BACKGROUND & AIMS: BACKGROUND:Novel influenza viruses continue to pose a potential pandemic threat worldwide. In recent years, plants have been used to produce recombinant proteins, including subunit vaccines. A subunit influenza vaccine, HAC1, based on recombinant hemagglutinin from the 2009 pandemic A/California/04/2009 (H1N1) strain of influenza virus, has been manufactured using a plant virus-based transient expression technology in Nicotiana benthamiana plants and demonstrated to be immunogenic and safe in pre-clinical studies (Shoji et al., 2011). METHODS:A first-in-human, Phase 1, single-center, randomized, placebo-controlled, single-blind, dose escalation study was conducted to investigate safety, reactogenicity and immunogenicity of an HAC1 formulation at three escalating dose levels (15 μg, 45 μg and 90 μg) with and without Alhydrogel(®), in healthy adults 18-50 years of age (inclusive). Eighty participants were randomized into six study vaccine groups, a saline placebo group and an approved monovalent H1N1 vaccine group. Recipients received two doses of vaccine or placebo (except for the monovalent H1N1 vaccine cohort, which received a single dose of vaccine, later followed by a dose of placebo). RESULTS:The experimental vaccine was safe and well tolerated, and comparable to placebo and the approved monovalent H1N1 vaccine. Pain and tenderness at the injection site were the only local solicited reactions reported following vaccinations. Nearly all adverse events were mild to moderate in severity. The HAC1 vaccine was also immunogenic, with the highest seroconversion rates, based on serum hemagglutination-inhibition and virus microneutralization antibody titers, in the 90 μg non-adjuvanted HAC1 vaccine group after the second vaccine dose (78% and 100%, respectively). CONCLUSIONS:This is the first study demonstrating the safety and immunogenicity of a plant-produced subunit H1N1 influenza vaccine in healthy adults. The results support further clinical investigation of the HAC1 vaccine as well as demonstrate the feasibility of the plant-based technology for vaccine antigen production.

背景与目标： 背景：新型流感病毒继续在全球范围内构成潜在的大流行威胁。近年来，植物已用于生产重组蛋白，包括亚单位疫苗。一种基于亚型流感疫苗，HAC1，其基于来自2009年大流行性A / California / 04/2009（H1N1）流感病毒株的重组血凝素，已经在基于烟草的本氏烟草中使用基于植物病毒的瞬时表达技术进行了生产。在临床前研究中具有免疫原性和安全性（Shoji等，2011）。
方法：进行了一项首次在人体内的1期，单中心，随机，安慰剂对照，单盲，剂量递增研究，以研究在三种递增剂量水平（15μg）下HAC1制剂的安全性，反应原性和免疫原性（含45μg和90μg）含和不含Alhydrogel（®）的健康成年人（年龄在18至50岁之间）。将80名参与者随机分为6个研究疫苗组，一个生理盐水安慰剂组和一个批准的单价H1N1疫苗组。收件人接受两剂疫苗或安慰剂（单价H1N1疫苗队列除外，后者接受单剂疫苗，随后再接受一剂安慰剂）。
结果：该实验疫苗安全且耐受性良好，与安慰剂和已批准的单价H1N1疫苗相当。注射后唯一的局部反应是注射部位的疼痛和压痛。几乎所有不良事件的严重程度均为轻度至中度。在第二次疫苗接种后的90μg非佐剂HAC1疫苗组中，基于血清血凝抑制和病毒微中和抗体滴度，HAC1疫苗也是具有免疫原性的，具有最高的血清转化率（分别为78％和100％）。
结论：这是第一项证明健康成人中植物产生的H1N1亚单位流感疫苗的安全性和免疫原性的研究。结果支持对HAC1疫苗的进一步临床研究，并证明了基于植物的技术生产疫苗抗原的可行性。

BACKGROUND & AIMS: Immunogenicity and tolerability of a new formalin-inactivated, alum-adjuvanted whole virus vaccine against hepatitis A (VAQTA, MSD, West Point, USA) were evaluated by immunizing 52 healthy, anti-HAV negative volunteers with a 1 ml dose. A booster dose was given 6 months later. In these young adult vaccinees [27 males and 25 females, 19-34 (mean 26) years of age] VAQTA proved to be well tolerated and highly immunogenic. Two weeks after administration of one vaccine dose, all but one of the recipients (98%) had anti-HAV concentrations above the presumed minimum protective level of 10 IU l-1 with a geometric mean concentration (GMC) of 165 IU l-1. After 4 weeks, a 100% seroconversion rate could be demonstrated with a fourfold increase of the GMC to 728 IU l-1. Six months after vaccination, all but one of the 50 volunteers coming back for booster (98%) showed anti-HAV levels within the protective range. The antibody concentrations had decreased in the majority of vaccinees to a GMC of 362 IU l-1. The booster dose given at that time was shown to be very effective, leading to a pronounced rise of anti-HAV levels in all recipients with a 17-fold increase of the GMC to 6040 IU l-1. Six months after the booster, all vaccinees were still seropositive with a GMC of 3444 IU l-1. Higher antibody levels were found in females, the difference being significant 4 weeks and 6 months after vaccination and 4 weeks after booster. No serious local or systemic adverse reactions were observed.

背景与目标： 通过用1 ml剂量对52名健康，抗HAV阴性志愿者进行免疫接种，评估了新的福尔马林灭活的明矾灭活的明矾佐剂抗A型肝炎全病毒疫苗（VAQTA，MSD，西点，美国）的免疫原性和耐受性。 6个月后给予加强剂量。在这些年轻的成年疫苗中（男性27例，女性25例，年龄19-34岁（平均26岁）），VAQTA被证明具有良好的耐受性和高度免疫原性。接种一剂疫苗后两周，除一名接受者外，其他所有接受者（98％）的抗HAV浓度均高于假定的最低保护水平10 IU l-1，几何平均浓度（GMC）为165 IU l-1 。 4周后，可以证明血清转化率为100％，而GMC增加了四倍，达到728 IU l-1。接种疫苗六个月后，回来参加加强免疫的50名志愿者中，只有一名（98％）显示出抗HAV水平在保护范围内。在大多数疫苗中，抗体浓度降低至362 IU -1的GMC。当时给予的加强剂量被证明是非常有效的，导致所有接受者的抗HAV水平显着上升，而GMC上升至6040 IU -1则增加了17倍。加强免疫6个月后，所有疫苗仍呈血清阳性，GMC为3444 IU-1。在女性中发现较高的抗体水平，接种后4周和6个月以及加强后4周，差异显着。没有观察到严重的局部或全身不良反应。

BACKGROUND & AIMS: :An open, randomized multi-center trial, involving 700 infants, was conducted in order to compare a new measles mumps rubella (MMR) vaccine, SB MMR (containing a Jeryl Lynn derived mumps strain RIT 4385) with a widely used vaccine, Merck MMR, when given to children between 12-24 months. Infants were divided between 2 groups; group 1 received SB MMR while group 2 received Merck MMR. Solicited local and general symptoms were recorded using diary cards and antibody levels were measured using ELISA assays. There was a significantly lower incidence of redness (p < 0.001) and swelling (p = 0.03) observed in group 1 compared with group 2. The incidence of all other solicited local and general symptoms were comparable between groups. In initially seronegative subjects equivalent seroconversion rates and post-vaccination GMTs were observed between groups. In conclusion, these results demonstrate that SB MMR is safe and well tolerated when given to children at this age range, and has an equivalent immunogenic profile compared to the widely used Merck MMR vaccine.

背景与目标： ：进行了一项涉及700名婴儿的开放随机随机多中心试验，目的是比较一种新的麻疹腮腺炎风疹（MMR）疫苗SB MMR（包含Jeryl Lynn衍生的腮腺炎菌株RIT 4385）与一种广泛使用的疫苗默克给12至24个月的儿童服用MMR。婴儿分为两组。第1组收到SB MMR，而第2组收到默克MMR。使用日记卡记录请求的局部和一般症状，并使用ELISA测定法测量抗体水平。与第2组相比，第1组的发红（p <0.001）和肿胀（p = 0.03）发生率显着降低。所有其他引起的局部和一般症状的发生率在各组之间是相当的。在最初的血清阴性受试者中，各组之间观察到了相同的血清转化率和疫苗接种后GMT。总之，这些结果表明，当给该年龄段的儿童服用SB MMR时，它是安全且耐受性良好的，与广泛使用的默克MMR疫苗相比，它具有同等的免疫原性。

BACKGROUND & AIMS: BACKGROUND:Tuberculosis remains the leading cause of human death. Currently, Bacillus Calmette-Guérin (BCG) is the only available vaccine against tuberculosis but its efficacy is highly variable. Thus, developing new tuberculosis vaccines becomes an urgent task. In this study, we evaluated in BALB/c mice the humoral and cellular immune responses of recombinant BCG expressing the antigen ESAT-6 from Mycobacterium tuberculosis. METHODS:Escherichia coli-BCG shuttle plasmid named pDE22-esat-6 was constructed by inserting the BamHI/EcoRI digested esat-6 gene PCR product into the similarly digested parental plasmid pDE22. BCG cells were transformed with pDE22-esat-6, which was named recombinant BCG (rBCG). BALB/c mice were immunized subcutaneously on the back with 100 microl normal saline containing 10(6) CFU of BCG or rBCG. They were sacrificed after 4 weeks to detect their humoral and cellular responses. RESULTS:There was no any significant differences in the growth characteristics between the conventional BCG and rBCG. In immunized mice, the IgG antibody titres of rBCG group were as high as 1:8000, which was significantly higher than that in BCG group (1:1400, P < 0.05). The elicited IFN-gamma level of rBCG group was (1993 +/- 106) pg/ml, which was also significantly higher than that in BCG group ((1463 +/- 105) pg/ml, P < 0.05). The splenocyte proliferation index of rBCG group reached 4.34 +/- 0.31, which was higher than that of BCG group (3.79 +/- 0.24, P < 0.05). CONCLUSION:rBCG secreted expressing antigen ESAT-6 stimulated stronger humoral and cellular immune responses than BCG did, and, therefore may be the better vaccine against mycobacterium tuberculosis.

背景与目标： 背景：结核病仍然是人类死亡的主要原因。目前，卡介苗芽孢杆菌（BCG）是唯一可用的抗结核疫苗，但其功效是高度可变的。因此，开发新的结核疫苗成为当务之急。在这项研究中，我们评估了BALB / c小鼠表达结核分枝杆菌抗原ESAT-6的重组BCG的体液和细胞免疫反应。
方法：通过将BamHI / EcoRI消化的esat-6基因PCR产物插入相似消化的亲本质粒pDE22中，构建大肠埃希菌-BCG穿梭质粒pDE22-esat-6。用称为重组BCG（rBCG）的pDE22-esat-6转化BCG细胞。 BALB / c小鼠的背部皮下注射100毫升含10（6）CFU BCG或rBCG的生理盐水。 4周后将其处死以检测其体液和细胞反应。
结果：常规BCG和rBCG之间的生长特性没有任何显着差异。在免疫小鼠中，rBCG组的IgG抗体效价高达1：8000，明显高于BCG组（1：1400，P <0.05）。 rBCG组引起的IFN-γ水平为（1993 /-106）pg / ml，也显着高于BCG组（（1463 /-105）pg / ml，P <0.05）。 rBCG组脾细胞增殖指数达到4.34 /-0.31，高于BCG组（3.79 /-0.24，P <0.05）。
结论：分泌的表达ESAT-6抗原的rBCG比BCG刺激更强的体液和细胞免疫反应，因此可能是更好的结核分枝杆菌疫苗。

BACKGROUND & AIMS: STUDY OBJECTIVE:To evaluate the safety and immunogenicity of recombinant human thrombin (rThrombin), an active topical stand-alone hemostatic agent. DESIGN:Analysis of pooled data from 10 rThrombin clinical trials. PATIENTS:A total of 644 adult and pediatric patients treated with rThrombin; 609 patients were included in the immunogenicity analysis. MEASUREMENTS AND MAIN RESULTS:In all studies, rThrombin was applied during a single surgical procedure (day 1); the procedures consisted of spinal procedures, major hepatic resection, peripheral arterial bypass, arteriovenous graft formation for hemodialysis access, and synchronous burn wound excision and skin grafting. A dosage of 1000 IU/ml of rThrombin was administered for more than 99% of patients. Adverse events and clinical laboratory values were monitored through day 29. Blood samples were obtained for immunogenicity analyses before the procedure and on day 29. Adverse events were mild or moderate in severity for the majority of patients; no patients discontinued from an rThrombin study due to adverse events. The most commonly reported adverse events in the 644 patients were incision site pain (305 patients [47.4%]), procedural pain (215 patients [33.4%]), and nausea (170 patients [26.4%]). Five patients (0.8%) died during the studies; all deaths were considered unrelated to rThrombin treatment. Antibodies to the rThrombin product developed in 5 (0.8%, 95% confidence interval 0.4-2.8%) of 609 patients by day 29, approximately 1 month after treatment; these antibodies did not neutralize the activity of native human thrombin. The development of antibodies did not appear to differ substantively by type of surgical procedure, amount of rThrombin administered, or patient age. CONCLUSION:Recombinant human thrombin was well tolerated, and adverse events were consistent with those reported in the postoperative setting in the surgical populations studied. Approximately 1 month after treatment, less than 1% of the patients had developed antibodies to the rThrombin product, and these antibodies did not neutralize the activity of native human thrombin. These results support the safety of rThrombin when used as a topical aid to hemostasis in numerous surgical settings and for patients of differing ages.

背景与目标： 目的：评价重组人凝血酶（rThrombin）的安全性和免疫原性。
设计：对来自10个rThrombin临床试验的汇总数据进行分析。
患者：共644名接受r凝血酶治疗的成人和儿童患者； 609例患者被纳入免疫原性分析。
测量和主要结果：在所有研究中，rThrombin均在单次手术过程中应用（第1天）。程序包括脊柱程序，大肝切除，外周动脉搭桥，动静脉移植物形成以进行血液透析以及同步烧伤创面切除和皮肤移植。超过99％的患者服用1000IU / ml的rThrombin。在第29天监测不良事件和临床实验室值。在手术前和第29天采集血样进行免疫原性分析。没有患者因不良事件而中断r凝血酶研究。在644例患者中，最常报告的不良事件是切口部位疼痛（305例患者[47.4％]），程序性疼痛（215例患者[33.4％]）和恶心（170例患者[26.4％]）。五名患者（0.8％）在研究期间死亡；所有死亡均与凝血酶治疗无关。到第29天（治疗后约1个月），在609例患者中，有5种（0.8％，95％置信区间0.4-2.8％）出现了针对rThrombin产品的抗体；这些抗体没有中和天然人凝血酶的活性。抗体的产生似乎在外科手术类型，rThrombin施用量或患者年龄方面无显着差异。
结论：重组人凝血酶耐受性好，不良事件与术后人群在手术后的报道一致。治疗后约1个月，不到1％的患者已开发出针对rThrombin产品的抗体，这些抗体并未中和天然人凝血酶的活性。这些结果证明r凝血酶在许多手术场合和不同年龄的患者中用作止血的局部辅助药物时的安全性。

BACKGROUND & AIMS: BACKGROUND:Vaccines against hepatitis A provide long-lasting protection in both adults and children. The aim of this study was to demonstrate that the inactivated hepatitis A vaccine AVAXIM 80U Pediatric is safe and not inferior in terms of seroprotection rate to HAVRIX 720 vaccine 1 month after booster vaccination. METHODS:An open, randomized, single-center trial was conducted in China in healthy antihepatitis A virus seronegative individuals from 12 months to 15 years of age. Participants were randomized in a 2:1 ratio to receive either AVAXIM 80U Pediatric or HAVRIX 720, followed by a booster vaccination, using the same vaccine 6 months afterward. RESULTS:A total of 720 individuals were included in the study, 480 in the AVAXIM 80U Pediatric group and 240 in the HAVRIX 720 group, and 686 individuals completed the full vaccination schedule. AVAXIM 80U Pediatric was statistically noninferior to HAVRIX 720 in terms of seroprotection rate for all individuals and in each of 3 age groups: toddlers (12-23 months), children (2-11 years) and adolescents (12-15 years). Antihepatitis A virus geometric mean titers were significantly higher with AVAXIM 80U Pediatric than with HAVRIX 720. Both inactivated hepatitis A vaccines were well-tolerated and had a similar incidence and type of adverse events. CONCLUSION:AVAXIM 80U Pediatric is safe and immunogenic, with a seroprotection rate that is not inferior to HAVRIX 720 in a pediatric population of healthy individuals.

背景与目标： 背景：抗甲型肝炎疫苗对成人和儿童均提供长期的保护。这项研究的目的是证明灭活的甲型肝炎疫苗AVAXIM 80U儿科疫苗加强免疫后1个月，其血清保护率相对于HAVRIX 720疫苗而言并不逊色。
方法：在中国进行了一项开放，随机，单中心试验，研究对象是健康的抗12个月至15岁的甲型肝炎病毒血清阴性个体。参与者以2：1的比例随机分配，以接受AVAXIM 80U Pediatric或HAVRIX 720，然后在6个月后使用相同的疫苗进行加强免疫。
结果：总共720人被纳入研究，AVAXIM 80U儿科组为480人，HAVRIX 720组为240人，有686人完成了完整的疫苗接种时间表。就所有个体以及三个年龄组中的每个年龄组（幼儿（12-23个月），儿童（2-11岁）和青少年（12-15岁））的血清保护率而言，AVAXIM 80U儿科在统计学上均不逊于HAVRIX 720。 AVAXIM 80U儿科患者的抗A型肝炎病毒几何平均滴度显着高于HAVRIX720。两种灭活的A型肝炎疫苗均具有良好的耐受性，并且不良事件的发生率和类型相似。
结论：AVAXIM 80U儿科是安全且具有免疫原性的，其血清保护率不低于健康个体儿科患者的HAVRIX 720。

BACKGROUND & AIMS: BACKGROUND:p53-mutations are of major importance in the development of human malignancies and occur frequently in head and neck cancer. The detection of serum p53-antibodies has been performed for a number of different cancers. For head and neck cancer though, the occurrence of serum p53-antibodies has not been determined so far.

MATERIALS AND METHODS:A set of 82 sera from patients with squamous cell carcinomas of the head and neck were screened for circulating antibodies against p53 with ELISA.

RESULTS:Of 82 patients 22% (n = 18) demonstrated p53-antibodies in their sera; the specificity for malignancy was 100%.

CONCLUSIONS:As far as we know, this is the first study to reveal p53-antibodies in the sera of patients with SCCHN. The high incidence of positivity for p53-antibodies in this subset of cancer patients may give additional help in the diagnosis of this often disfiguring disease.

背景与目标： 背景：p53突变在人类恶性肿瘤的发展中非常重要，并且经常发生在头颈癌中。已针对多种不同的癌症进行了血清p53抗体的检测。对于头颈癌，到目前为止，尚无血清p53抗体的测定。

材料和方法：一组来自82例鳞状细胞癌患者的血清

结果：在82例患者中，有22％（n = 18）的患者血清中显示了p53抗体；结论：恶性肿瘤的特异性为100％。

结论：据我们所知，这是第一项揭示SCCHN患者血清中p53抗体的研究。在这种癌症患者中，p53抗体阳性率很高，这可能有助于诊断这种经常毁容性的疾病。