甲型肝炎灭活疫苗在大学生中加强免疫的效果研究

目的 评价甲型肝炎（甲肝）灭活疫苗在成年人中加强免疫的效果和安全性。方法 选择参加健康成年人甲肝灭活疫苗和冻干甲肝减毒活疫苗随机双盲临床试验,基础免疫前甲肝抗体阴性并完成1针甲肝灭活疫苗或减毒活疫苗的大学生作为研究对象,加强免疫1针甲肝灭活疫苗,免疫前、免疫后28 d采血,检测抗甲肝病毒抗体滴度≥20 mIU/ml为阳性。结果 加强免疫前甲肝灭活疫苗组和减毒活疫苗组GMC分别为70.80 mIU/ml、50.12 mIU/ml;阳性率分别为94.7%、65.0%。加强免疫1针甲肝灭活疫苗后,两组的抗体阳性率均为100.0%,灭活疫苗组和减毒活疫苗组GMC分别为2 816.09 mIU/ml、2 654.55 mIU/ml。结论 接种1针甲肝灭活疫苗或减毒活疫苗3年后,甲肝抗体GMC和阳性率均有不同程度降低,灭活疫苗优于减毒活疫苗,两组进行1针灭活疫苗的加强免疫效果明显。     

孩尔来福甲型肝炎灭活疫苗用于加强免疫的研究

为了观察孩尔来福 (Healive○R)甲型肝炎 (甲肝 )灭活疫苗用于加强免疫的效果 ,对 1～ 10岁 1年内曾接种过甲肝减毒活疫苗而血清学检测 [酶联免疫吸附试验 (ELISA) ]抗甲肝病毒抗体 (抗 HAV)阴性的 70名农村儿童 ,加强免疫 1剂Healive○R甲肝灭活疫苗 ,并于加强接种后 1个月采血检测 (ELISA)甲肝抗 HAV。结果显示 :所有加强免疫的儿童抗 HAV阳转率为 10 0 0 % ,几何平均滴度 (GMT)为 30 13mIU/ml;并且与接种甲肝减毒活疫苗的时间间隔不同抗 HAVGMT也不同 ,间隔时间长者高于间隔时间短者 ,与不同免疫程序接种 2剂Healive○R甲肝灭活疫苗的免疫效果规律一致 ,但显著低于 2剂Healive○R的抗 HAVGMT。Healive○R甲肝灭活疫苗对有甲肝减毒活疫苗接种史的儿童进行加强免疫 ,可使其产生较高的抗 HAVGMT。     

甲型肝炎减毒活疫苗与灭活疫苗不同免疫程序免疫后7年血清学效果观察

目的观察甲型肝炎（甲肝）减毒活疫苗（Hepatitis A Attenuated Live Vaccine,HepA-L）不同免疫程序免疫后7年的抗体持久性,并与甲肝灭活疫苗（Hepatitis A Inactivated Vaccine,HepA-I）进行比较。方法按个体随机的方法,把筛检出的甲肝易感者随机分为A、B、C三组。A组按0、6、12个月程序接种3剂国产H2株HepA-L,B、C两组按0、6个月程序分别接种HepA-L和HepA-I,分别于免疫后1、6、7、12、13、24、84个月采集血清标本,检测抗甲肝病毒抗体（Anti-hepatitis A Virus Antibody,Anti-HAV）总抗体。结果三组Anti-HAV阳性率均于接种第2剂后1个月达100%,抗体峰值几何平均浓度（Geometric Mean Concentration,GMC）以C组最高,为2938.1mIU/ml（毫国际单位/毫升）,A、B组分别为1315.6mIU/ml、1586.0mIU/ml。A组于12个月时再加强免疫1剂,抗体GMC上升,达1945.3mIU/ml。首剂免疫后84个月,Anti-HAV阳性率三组均保持100%,尽管A组抗体GMC降至336.8mIU/ml,仍显著高于B、C两组。结论HepA-L近期加强免疫效果良好,抗体反应与持久性同HepA-I相当,远期效果有待于进一步观察。     

甲型肝炎减毒活疫苗加强免疫效果观察

为了观察我国研制的甲型肝炎减毒活疫苗 (甲肝活疫苗 )H2 株 (滴度为 10 6 5TCID50 /ml)与LA - 1株 (滴度为10 6 5TCID50 /ml)免疫原性及加强免疫后的抗体浓度 ,对两所幼儿园 3～ 6岁的儿童先进行初筛 ,将甲肝易感儿童列为观察对象 ,同时分为H2 株 (45人 )和LA - 1株 (43人 )两组 ,接种首针疫苗后 1个月采血 ,分离血清低温保存 ,间隔 12个月加强接种第 2针甲肝活疫苗 ,接种后 2～ 3个月采血 ,用统一试剂检测甲肝病毒抗体 (抗 -HAV)。结果显示 :首针接种后抗 -HAV总阳转率为 80 7% (71/ 88) ,H2 株和LA - 1株抗 -HAV阳转率分别为 82 2 %和79 1% ,几何平均浓度 (GMC)分别为 6 8 0mIU/ml和 83 8mIU/ml,抗体浓度≥ 2 0 0mIU/ml的分别占 17 8% (8/4 5 )和 2 3 3% (10 / 4 3)。间隔 12个月加强免疫后 ,抗 -HAV阳性率分别为 95 6 %和 97 7% ;抗体GMC分别为371 3mIU/ml和 312 1mIU/ml,抗体浓度≥ 2 0 0mIU/ml分别为 80 0 %和 79 1%。采用 0、12个月两针法接种国产甲肝活疫苗 (H2 株和LA - 1株 )效果良好     

儿童接种甲型肝炎灭活疫苗的抗体动态观察

<正>甲型肝炎(甲肝)疫苗(Hepatitis A Vaccine,HepA)是预防甲肝最有效的方法。国内外多项研究均报道接种一剂甲肝灭活(Inactivated)疫苗(HepA-Ⅰ)后最早在2周时出现较高抗体阳转率,还有文献报道,接种HepA-Ⅰ可在12d时诱导抗体阳转。为此观察了接种HepA-Ⅰ后8～29d抗体阳转率的动态变化,现简报如下。     

健康幼儿甲型肝炎灭活疫苗及甲乙型肝炎联合灭活疫苗再免疫血清学效果及安全性研究

目的评价甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine,Inactivated;HepA—I）和甲乙型肝炎联合灭活疫苗（Hepatitis A and B Combined Vaccine,Inactivated;HepAB—I）一剂再免疫的血清学效果和安全性。方法采用开放式临床研究设计,选择210名已经完成乙型肝炎（乙肝）疫苗（Hepatitis B Vaccine,HepB）全程免疫、且接种甲肝减毒活疫苗（Hepatitis A Attenuated Live Vaccine,HepA-L）≥6个月的24-38月龄儿童,分为2个试验组,分别接种1剂HepA—J和HepAB—I,并在免疫前和免疫后1个月,对受试者采血检测抗甲肝病毒抗体（Antibodyto Hepatitis A Virus,Anti—HAV）与抗乙肝病毒表面抗原抗体（Antibodvto Hepatitis B Virtus Surface Antigen,Anti-HBs）,并对受试者连续3d测体温,并观察可能发生的任何临床症状和随访,以评价两种疫苗的安全性。结果HepA—I组受试者再免疫1个月后,Anti—HAV阳性[≥20毫国际单位（mIU）／毫升（ml）]率由免疫前的95．1％上升到100．0％,几何平均浓度（Geometric Mean Concentration,GMC）由免疫前的124．41mIU／ml上升到7269.31mIU／ml,增长55．74倍。HepAB—I组,Anti—HAV阳性率由免疫前的88．8％上升到98．9％,GMC由免疫前的98．03mIU／ml上升到5174．76mlU／ml,增长58．35倍。HepAB—I组Anti—HBs阳性[≥10mIU／m1]率由免疫前的72．9％上升到97．8％;GMC由免疫前的22．20mlU／ml上升到1226．14mIU／ml,增长54．49倍。此次试验共观察到12例不良反应,均为发热,发生率为5．7％;未发现其他不良反应。结论在健康幼儿再免疫1剂HepA—I、HepAB—I后,血清学效果和安全性良好。     

甲型肝炎灭活疫苗的稳定性研究

目的　观察甲型肝炎(甲肝)灭活疫苗在2℃～8℃保存条件下的稳定性。方法　在2℃～8℃保存条件下,用不同批号的甲肝灭活疫苗免疫动物,检测血清抗体效价,进行效力试验评价;按2 0 0 0年版《中国生物制品规程》测定pH值变化情况,进行异常毒性试验和无菌试验。结果　5批甲肝灭活疫苗在2℃～8℃保存4 2个月半数有效量(ED50 )无明显变化,无菌试验阴性,异常毒性试验合格,pH值变化<0 2 ,不同抗原含量保存在2℃～8℃30个月也无明显变化,批间无明显差异。结论　医学生物学研究所生产的甲肝灭活疫苗2℃～8℃条件下可保存3年,其免疫原性无明显变化,其它理化指标均符合《中国生物制品规程》要求。     

甲型肝炎灭活疫苗有效剂量的评价

目的评价佐剂吸附甲型肝炎成品疫苗有效免疫剂量。方法将4个厂家的4批甲型肝炎灭活疫苗进行解离吸附后，检测比较HAV抗原含量；通过小白鼠体内效力实验，计算半数有效稀释倍数，比较评价各组疫苗的免疫效力。结果体外吸附解离HAV抗原含量与体内免疫效力相偏离，传统概念上的半数有效剂量(ED50)不能用作比较评价指标。结论体内半数有效稀释倍数可用于甲型肝炎灭活疫苗有效剂量的评价。     

健康儿童接种国产甲型肝炎灭活疫苗的免疫效果研究

目的评价国产甲型肝炎(甲肝)灭活疫苗(hepatitis A vaccine,inactivated;HepA-I)的免疫原性及免疫持久性。方法采用随机双盲设对照的临床研究设计,试验疫苗使用国产HepA-I,选取进口HepA-I做对照,试验疫苗与对照疫苗的比例为3:1,其中国产HepA-I的剂量为每支250单位(Unit,U)/0.5 ml(ml),进口HepA-I的剂量为每支720 ELISA单位(enzyme linked immunosorbent assay unit,Elu)/0.5 ml。在常州市武进区筛选出213名2~8岁健康儿童为受试者,完成0、6个月免疫程序接种后连续观察5年,每年采血检测抗甲肝病毒抗体(antibody to hepatitis A virus,Anti-HAV)。结果完成全程免疫后1个月以及第1~4年,试验组和对照组阳性率均为100%,第5年两组分别为99.1%和97.3%;完成全程免疫后1个月,试验组和对照组Anti-HAV的几何平均滴度(geometric mean concentration,GMC)为4 079.6毫国际单位(mIU)/ml和1 394.6mIU/ml,至第5年Anti-HAVGMC分别为308.2mIU/ml和195.1 mIU/ml,差异均有统计学意义(分别t=6.577,P<0.001;t=2.748,P=0.007)。结论国产HepA-I在全程免疫接种后的免疫原性及免疫持久性良好。     

龙口市健康儿童甲乙型肝炎联合疫苗加强免疫效果评价

[目的]评价甲乙型肝炎联合疫苗一针加强免疫程序的免疫效果和安全性,为完善甲肝疫苗和乙肝疫苗免疫预防策略提供决策依据。[方法]选择210名24～38月龄儿童,随机分为2组：实验组接种1剂次甲乙肝联合疫苗,对照组接种1剂次甲肝灭活疫苗。免后1个月,采用定量微粒子酶联免疫法检测甲肝抗体,采用抗-HBs化学发光法检测乙肝抗体,评价免疫前后甲、乙肝抗体水平（GMC）和阳性率。并对受试者进行连续3d体温及可能发生的任何临床症状观察和随访,以评价其安全性。[结果]对照组（甲肝疫苗组）加强免疫1个月后甲肝抗体阳性率由免前的95．20％上升到100．00％,GMC增长倍数达55．74倍。实验组（甲乙联苗组）甲肝抗体阳性率由免前的88．80％上升到98．90％,GMC增长58．35倍。乙肝抗体阳性率由免前的的72．90％上升到97．80％,增长24．90％;GMC由免前的22．20mIU／ml上升到1226．10mIU／ml,增长54．50倍。观察到12例不良反应,均为发热,发生率为5．74％,未发现其他不良反应。[结论]甲乙型肝炎联合疫苗进行加强免疫具有良好的免疫原性和安全性,建议增加1剂次甲乙联苗加强免疫程序,帮助接种者获得长期的甲肝、乙肝抗体保护。     

儿童甲乙型肝炎联合疫苗加强免疫效果评价

目的比较甲、乙型肝炎联合疫苗(hepatitis A and hepatitis B combined vaccine,HepA and HepB)加强免疫效果,为加强免疫决策提供依据。方法选择1周岁内完成乙型肝炎(乙肝)疫苗(hepatitis Bvaccine,HepB)基础免疫的5岁以上儿童1 387例,采集血清,使用化学发光法检测乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc)、甲肝病毒抗体(抗-HAV),对儿童接种甲乙肝联合疫苗一剂次,免后1月采血检测抗-HBs、抗-HAV。结果加强免疫前、加强免疫一剂次甲乙肝联合疫苗后,抗-HBs阳性率分别为49.32%、93.58%,抗-HAV阳性率分别为63.52%、93.08%,加强免疫前后抗-HBs阳性率和抗-HAV阳性率差异均有统计学意义(P均<0.05)。加强免疫一剂次甲乙肝联合疫苗后,抗-HBs阳转率、抗-HAV阳转率分别为87.34%、81.03%,且5～14岁儿童抗-HBs阳转率、抗-HAV阳转率均随年龄增加呈下降趋势(P<0.05)。加强免疫一剂次甲乙肝联合疫苗后,抗-HBs、抗-HAV几何平均滴度(GMT)分别为1326.97U/L、11.11U/L。结论采用甲乙肝联合疫苗对小年龄儿童加强免疫一剂次免疫效果良好,对大年龄儿童建议增加加强免疫剂次。     

Concurrent administration of inactivated hepatitis A vaccine with immune globulin in healthy adults

301 healthy adult volunteers were randomized to one of three treatment groups: inactivated hepatitis A vaccine alone; inactivated hepatitis A vaccine with immune globulin (Ig) concurrently; or Ig alone. The first two treatment groups received a second dose of hepatitis A vaccine at week 24. Anti-HAV was measured 4, 8, 12, 24 and 28 weeks after the primary immunization. When comparing subjects receiving inactivated hepatitis A vaccine alone to those receiving vaccine and Ig, the seropositivity rates were not significantly different at 4, 8, 12 and 28 weeks, but at week 24 the seropositivity rate was lower in the group receiving both vaccine and Ig compared to the group receiving vaccine alone (92.0% compared to 97.0%). At weeks 8, 12 and 24 the geometric mean titers (GMTs) were significantly lower for subjects receiving both vaccine and Ig. The GMTs were not significantly different after the second dose of vaccine. At all time points, the lower serum antibody concentrations observed in subjects receiving both inactivated hepatitis A vaccine and Ig were nevertheless substantially higher than the cutoff for assay seropositivity and much higher than after Ig alone; these differences are therefore clinically insignificant.     

Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults

For global eradication of poliomyelitis, inactivated poliovirus vaccine (IPV) needs to become available in all countries. Using fractional-doses (reduced-doses) may impact affordability and optimize the utilization of the production capacity. Intradermal administration has the potential to lower the dose without reducing immunogenicity. A needle-free jet injector may be a reliable way to administer vaccines intradermally. The primary objective of this randomized controlled trial was to compare the immunogenicity and tolerability of fractional-dose intradermal IPV (Netherlands Vaccine Institute, NVI) booster vaccination administered with a jet injector (PharmaJet) to full-dose and fractional-dose intramuscular vaccination with a needle and syringe. Immunogenicity was assessed by comparing the differences in the post-vaccination log₂ geometric mean concentrations of neutralizing antibodies (GMC) between the study groups. A total of 125 Dutch adult volunteers with a well-documented vaccination history were randomized to one of four groups: full-dose intramuscular needle (IM-NS-0.5), full-dose intramuscular jet injector (IM-JI-0.5), 1/5th dose intramuscular needle (IM-NS-0.1), 1/5th dose intradermal jet injector (ID-JI-0.1). Vaccination with the JI was less painful (87% no pain) than vaccination with a NS (60% no pain), but caused more transient erythema (JI 85%, NS 24%) and swelling (JI 50%, NS 5%). Intradermal vaccination caused less vaccination site soreness (ID 16%, IM 52%). At baseline all subjects had seroprotective antibody concentrations. After 28 days, GMC were slightly lower in the ID-JI-0.1 group than in the reference group (IM-NS-0.5). The differences were not statistically significant, but the stringent non-inferiority criterion (i.e. a difference of 1 serum dilution in the microneutralization assay) was not met. After one year, differences in GMC were no longer apparent. In contrast, intramuscular vaccination with a fractional dose administered with a needle (IM-NS-0.1) was statistically inferior to full-dose intramuscular vaccination. This shows that intradermal but not intramuscular delivery of fractional-dose IPV may be sufficient for routine polio vaccination.     

Safety and immunogenicity of an inactivated hepatitis A candidate vaccine in healthy adult volunteers

The reactogenicity and immunogenicity of a formaldehyde-inactivated hepatitis A vaccine have been investigated. Three different dose levels of vaccine (180, 360 and 720 ELISA units) were administered to healthy volunteers according to a 0, 1, 2 and 12 month schedule. The vaccine was safe and well tolerated. Reactions observed following vaccination were essentially mild and were not dependent upon the quantity of antigen administered. All subjects had measurable titres of anti-HAV antibodies after the full vaccination course; the immune response to the vaccine was dose-related. Antibody titres in vaccinees at month 13 were between 60- and 190-fold higher than those observed in a group of subjects given anti-HAV immunoglobulin.     

中国甲型肝炎减毒活疫苗和灭活疫苗免疫效果与安全性评价

目的评价中国甲型肝炎(甲肝)减毒活疫苗(HepA-L )和甲肝灭活疫苗(HepA-I )的安全性及免疫效果，为甲肝暴发疫情疫苗应急接种提供参考依据。方法用美国雅培(Abbott)公司生产的抗甲肝病毒抗体(抗一HAV)试剂筛查未感染HAV的6~9岁儿童。将人选对象随机分为4组，分别接种国产HepA-L和HepA-I，以国产重组乙肝疫苗(酿酒酵母)( HepB-SCY)为阴性对照，G1axoSmithKline Biologicals S.A.(GSK)生产的HepA-I为阳性对照，采取随机双盲方法观察接种疫苗后30 min及24,48,72 h的不良反应发生率。采用美国Abbott Laboratories生产的HAVAB 2.0试剂，利用微粒子酶免疫分析与电化学发光免疫测定法(MEIA)检测1,2,4周以及12个月的HAV IgG抗体水平。结果各组未发现严重不良反应，不良反应主要表现为发热、接种部位疼痛、硬结等。国产HepA-L和HepA-I组不良反应发生率分别为13.95%和15.25%，阳性对照组为16.80%，阴性对照组为25.62%，各组间差异无统计学意义。接种2周后，国产HepA-L和HepA-I抗体阳转率分别为85.00%和94.59%;接种后第4周，抗体阳转率达到100%;接种2,4.12周时试验组、阳性对照组HAV IgG抗体水平高于阴性对照组;接种12个月后，国产HepA-I组甲肝抗体水平高于阳性对照组。结论国产HepA-L和HepA-I以及进口HepA-I安全性良好，均具有较好的免疫效果。     

Clinical trial of a lyophilized inactivated hepatitis A candidate vaccine in healthy adult volunteers.

The safety and immunogenicity of a lyophilized inactivated hepatitis A vaccine was tested in healthy adult male volunteers. Thirty-six volunteers, all of whom were negative for antibody to HAV (anti-HAV), were divided into three dosage groups, 1.0, 0.5 and 0.25 micrograms of viral protein, respectively. Each group received a total course of three intramuscular injections at months 0, 1 and 6. Slight side effects were noted after 16 of 99 injections and the occurrence and degree were almost identical to those of other commercial vaccines. On the other hand, all subjects had measurable titres of serum anti-HAV neutralizing antibodies as early as 2 months after the first injection. The mean values of serum anti-HAV neutralizing antibodies at 7 months in the 1.0, 0.5 and 0.25 micrograms dose groups were 64-, 12-, and 9-fold higher, respectively, than those observed at 5 days in five recipients given 7.5 mg kg-1 body weight of immune serum globulin (ISG).     

Dose range evaluation of a new inactivated hepatitis A vaccine administered as a single dose followed by a booster

A total of 242 healthy adults were immunised with a first dose of an investigational inactivated hepatitis A vaccine. Three concentrations (3, 6 and 12 EU [ELISA units]) of the experimental vaccine were used and compared to a licensed reference vaccine. The aim was to determine the antigenic concentration of the study vaccine inducing the highest seroconversion rate and anti-Hepatitis A virus (HAV) antibody response at 2 weeks after the primary immunisation. A booster dose was given at month 6. At 15 days after the primary immunisation the seroconversion rates in subjects vaccinated with the 6 and 12 EU vaccines were 78 and 94%, respectively. At 30 and 180 days after the primary immunisation the percentages of seropositivity were 100% for both groups. The antibody response to the 12 EU study vaccine was similar to that to the reference vaccine. The percentages of seropositivity at 15 and 180 days after the primary immunisation were 94 vs 93%, and 100 vs 93% in the experimental and reference vaccine respectively. Thus, because it induces early and lasting seroconversion, the 12 EU study vaccine seems to be the most effective as a high potency HAV vaccine.     

2789例10岁以上儿童重组乙型肝炎疫苗加强免疫效果评价

目的 比较不同重组乙型肝炎(乙肝)疫苗加强免疫效果.方法 选择1周岁内完成血源乙肝疫苗基础免疫的10岁以上儿童2789例,分别接种4种国内常用的不同重组乙肝疫苗,分为A、B、C、D4组,采集血清,使用化学发光法检测HBsAg、抗-HBs、抗-HBc,仅抗-HBs阳性者接种1剂次、抗-HBs阴性者接种3剂次相应疫苗,免疫1个月后采血检测抗-HBs.结果 加强免疫前、免疫1剂次及3剂次后A、B、C、D 4组抗-HBs阳性率分别为36.43%、37.59%、42.91%、46.46%;89.20%、91.52%、90.96%、85.45%;99.12%、99.47%、98.87%、98.85%;加强免疫前、免疫1剂次及3剂次后两两之间抗-HBs阳性率差异均有统计学意义(P值均＜0.05).抗-HBs阴性者加强免疫1剂次、3剂次后,抗-HBs阳转率分别为83.01%、86.41%、84.16%、72.82%;98.62%、99.16%、98.03%、97.84%;与抗-HBs阳性者加强免疫1剂次相比,4组抗-HBs阳转率差异均有统计学意义(P＜0.05).抗-HBs阳性者加强免疫1剂次后几何平均滴度(GMT)分别为2853.21、6254.23、3581.40、3021.32 mIU/ml.抗-HBs阴性者加强免疫1剂次、3剂次后4组GMT分别为273.08、648.52、387.87、245.36 mIU/ml;632.30、2341.14、563.97、394.08 mIU/ml.结论 采用上述4种重组乙肝疫苗对抗-HBs阳性的10岁以上儿童加强免疫1剂次、对抗-HBs阴性的10岁以上儿童加强免疫3剂次,免疫效果良好.

Abstract：

Objective To study the efficiency of booster immunization with different recombinant hepatitis B vaccines.Methods 2789 children aged over 10 years who had completed the basic immunization of hepatitis B vaccine under 1 year old were selected.All the sampled children were classified into four groups (A,B,C and D) and immunized with different hepatitis B vaccines produced by different campanies respectively.Before booster immunization,their blood plasma specimens were detected for hepatitis B virus (HBV) surface antigen (HBsAg),antibodies to HBV surface antigen (anti-HBs) and antibodies to HBV core antigen (anti-HBc) by chemiluminescence.In each group,the anti-HBs positive children were immunized with one dosage and anti-HBs negative children were immunized three dosages of the same vaccine.Their blood specimens were collected again after 1 month,and detected for anti-HBs.Results The anti-HBs positive rates of A,B,C and D group were 36.43%,37.59%,42.91% and 46.46% respectively before immunization while 89.20%,91.52%,90.96% and 85.45% respectively after immunization with one dosage,99.12%,99.47%,98.87% and 98.85% respectively after immunization with three dosages.The differences of anti-HBs positive rates in the four respective groups showed statistical significances between any two rates of pre-immunization,post-immunization with one dosage and post- immunization with three dosages (all P＜0.05).The anti-HBs positive conversion rates of four groups were 83.01%,86.41%,84.16% and 72.82% respectively after immunization with one dosage.The anti-HBs positive conversion rate of four groups were 98.62%,99.16%,98.03% and 97.84% respectively after immunization with three dosages and the difference of positive conversion rates in each group showed statistical significances between booster immunization with one dosage and booster immunization with three dosages.The average GMTs in anti-HBs positive children in the four groups were 2853.21,6254.23,3581.40 and 3021.32 mIU/ml respectively after immunization with one dosage.The average GMTs of anti-HBs negative children in the four groups were 273.08,648.52,387.87 and 245.36 mIU/ml respectively after immunization with one dosage,and were 632.30,2341.14,563.97 and 394.08 mIU/ml respectively after immunization with three dosages.Conclusion Our data showed that it would be suitable to anyone to use the four vaccines for anti-HBs positive children aged over 10 years with one dosage and for anti-HBs negative children aged over 10 years with three dosage booster immunization.     

广东省实施新生儿乙肝疫苗接种后免疫效果评价

目的评价实施新生儿乙肝疫苗接种后的免疫效果。方法采用多阶段随机抽样方法,于2006年9月在广州市越秀区、云浮市云城区、汕尾市城区、肇庆四会市、韶关南雄县、梅州五华县等6个国家疾病监测点,抽取1～14岁儿童进行调查,用酶联免疫吸附试验方法检测HBV血清标志物[乙肝病毒表面抗原(HBsAg)、乙肝病毒表面抗体(抗-HBs)、乙肝病毒核心抗体(抗-HBc)],并与1992年同年龄段儿童的HBV流行情况进行比较。结果共调查1951名1～14岁儿童,其乙肝疫苗全程接种率为59.7%(1165/1951),其中1～4岁为88.8%(649/731),5￣14岁为42.3%(516/1220);1￣14岁儿童中免疫组HBsAg阳性率(2.3%,28/1211)低于未免疫组(10.8%,18/167)和免疫史不详组(7.5%,43/573),差异有统计学意义(P<0.01);乙肝疫苗首针在出生后当天或第2天接种儿童的HBsAg阳性率为1.4%(10/734),低于第3天以后才接种者(3.8%,18/477),差异有统计学意义(P<0.05);1￣14岁儿童HBsAg阳性率为4.6%(89/1951),其中1￣4岁儿童HBsAg阳性率为1.9%(14/731),与1992年比较分别下降了76.9%、88.6%(P<0.01)。结论实施新生儿乙肝疫苗接种取得良好免疫效果,出生后及时接种免疫效果更好。