Absence of antibodies to HTLV-III in health workers after hepatitis B vaccination

A proportion of the plasma for the triply inactivated, plasma-derived hepatitis B vaccine produced in the United States is obtained from homosexual men. Because homosexual men are a high-risk group for the acquired immunodeficiency syndrome (AIDS), concern has emerged that the vaccine could harbor the AIDS agent. To evaluate this risk, we tested 15-month postvaccination serum samples for antibodies to human T-cell lymphotropic virus type III in 100 health care workers who had received inactivated hepatitis B vaccine lots made from plasma collected between 1977 and 1979 and 100 who had received placebo injections. None of the 200 health workers had serological evidence of human T-cell lymphotropic virus type III infection. These serological findings lend additional support to earlier epidemiologic and immunologic observations suggesting that hepatitis B vaccine does not transmit infection with an AIDS virus.     

乙型肝炎疫苗预防效果研究

乙型肝炎是我国重大传染病,乙肝疫苗是预防和控制乙肝病毒感染的流行和传播最有效措施."九五"期间"乙肝疫苗预防效果研究"证实我国低剂量单纯乙肝血源疫苗的长期预防效果(新生儿免疫后15年内)持续为90%,新生儿完成全程免疫后无需加强免疫可有效预防乙肝病毒慢性感染而终生受益;乙肝疫苗明显具有免疫选择表面抗原基因变异株的作用;表面抗原基因变异株在未免疫携带者中主要是弱势准种;中国乙肝病毒基因型和血清型的分布有明显的地区性;我国乙肝基因工程疫苗(酵母、CHO)大面积推广使用安全、有效和可行;乙肝基因苗表面抗体阳转率和近期保护效果与相当剂量的血源疫苗效果相似;乙肝基因工程疫苗与50IU乙肝免疫球蛋白联合应用,可将母婴阻断效果提高到90%;我国目前推广乙肝疫苗的成本效益至少为135.     

Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial

The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B virus infections had occurred in vaccinated subjects (attack rate 4.8%) and 56 in subjects receiving a placebo (attack rate 23.8%). This reduction in the incidence of hepatitis B virus infections in vaccinated subjects was highly significant (p less than 0.0001). Two months after the first injection 72.3% of the vaccinated subjects had formed antibodies against hepatitis B surface antigen, and this percentage increased to 89% at four months. Maximum anti-HBs titres were reached five months after the first vaccination, the geometric mean titre being 107.6 mIU. Even vaccinated subjects with a low antibody response (greater than or equal to 1 and less than 10 mIU) were found to be protected from HBsAg-positive infections. The vaccine had no serious side effects.     

Impaired responsiveness of homosexual men with HIV antibodies to plasma derived hepatitis B vaccine

Thirty five homosexual men (17 positive for antibody to the human immunodeficiency virus (HIV) and 18 consistently negative) were vaccinated against hepatitis B virus infection. Eight of the 17 seropositive patients failed to develop detectable hepatitis B surface antibody within three months of the third injection compared with only one of the 18 seronegative patients (p less than 0.01). HIV infection is prevalent in the developed world in groups at risk for hepatitis B infection and in certain Third World countries where widespread vaccination programmes exist. This study shows the impact that coincident HIV infection may have on an otherwise efficacious vaccine. The efficacy of this and other vaccines in patients infected with HIV needs to be studied urgently.     

A two-dose combined vaccine against hepatitis A and hepatitis B in healthy children and adolescents compared to the corresponding monovalent vaccines

BACKGROUND: Immunization against hepatitis A and B has been available for some time, protecting against both infections. With a view to achieving further reduction in the number of interventions and increasing convenience of the vaccinee, we investigated the reactogenicity and immunogenicity of a combined hepatitis A and B vaccine in healthy 4- to 20-year-old subjects at a 0, 6-month schedule. METHODS: Two hundred forty-eight study subjects were allocated to two study groups and received either two doses of the combined hepatitis A and B vaccine (68% of subjects) or the corresponding monovalent hepatitis A and hepatitis B vaccines (32% of subjects) concomitantly in opposite arms. Reactogenicity was assessed via diary cards after each vaccination. Serum samples were analyzed at months 1, 2, 6, and 7. RESULTS: All vaccines were well tolerated and very few symptoms were scored as severe. All but one subject seroconverted for anti-hepatitis A virus (anti-HAV) antibodies (98.6%) and 100% of subjects seroconverted for anti-hepatitis B (HBs) antibodies, with respective seroprotection rates of 98.7% for the combined vaccine group and 95.9% for the concomitant vaccine group (p >0.05), respectively. Geometric mean titers were higher in the group receiving the combined vaccine: 6,635 mIU/mL vs. 2,728 mIU/mL (p = 0.0001) for anti-HAV and 3,362 mIU/mL vs. 1,724 mIU/mL (p = 0.0205) for anti-HBs, respectively. Younger subjects had a stronger immune response compared to older subjects. CONCLUSIONS: The combined hepatitis A and B vaccine was well tolerated at this two-dose schedule. The combined vaccine had higher immunogenicity, probably explained by a adjuvant effect of the antigens. Vaccination programs requiring fewer injections will most likely have a positive impact on compliance rate and comfort of the vaccinee.     

Markers of hepatitis B virus infection in schoolchildren in the Kimberley, Western Australia

In 1986 the Aboriginal community in Western Australia was identified as a high-risk group for hepatitis B virus infection. An immunization programme was commenced in 1988 but concerns were expressed about horizontal transmission, especially in schools, to the low-risk Caucasian group and whether they should also be included in the vaccination programme. To estimate the extent of this occurrence, a survey of schoolchildren from two district high schools in Broome and Derby in the Kimberley Region of Western Australia was carried out in March 1989. A total of 607 students aged 4 to 19 years were included in the study. None of the 300 Caucasian students had any serological markers of hepatitis B virus infection (95% confidence interval (CI) upper limit, 1.3%). Eighteen children were found to be seropositive for hepatitis B surface antigen (HBsAg); 17 were Aboriginal and one Asian. In addition, 61 Aboriginal students and one Asian had hepatitis B surface antibody (antiHBs). The hepatitis B virus infection rate in these Aboriginal children is 28.2% (95% CI, 23.2%-33.7%) with a carrier rate of 6.1% (95% CI, 3.9%-9.6%). This study demonstrates that Caucasian students have a very low risk of infection with hepatitis B virus in this community, and there is therefore no need to extend the hepatitis B vaccination programme beyond the already identified high-risk groups.     

LMP2/LMP7基因多态性与人群中乙型肝炎病毒感染相关性研究

目的:探讨低相对分子质量蛋白酶体(low molecular weight proteasome,LMP)基因单核苷酸多态性( single nucleotide polymorphisms,SNP )与人群中乙型肝炎病毒(hepatitis B virus,HBV)感染易感性的关联.方法:提取176例HBV感染者及208例健康人外周血基因组DNA,用PCR方法扩增LMP2/LMP7基因包含Codon60/Codon145两个多态性位点的片段,DNA直接测序法检测健康个体基因型,限制性片段长度多态性方法(restriction fragment length polymorphism,RFLP)明确HBV感染者基因型.并采用PHASE1.0软件构建这两个多态性位点的个体单倍体型.以非条件Logistic回归校正混杂因素,并进行多态性与HBV感染风险关联的统计学分析.结果:LMP7基因多态性位点在两组人群中的差异有统计学意义(P<0.05),较之野生型Q/Q,杂合型Q/K OR=2.11(95%CI:1.36～3.26),纯合型K/K OR=2.66(95%CI:1.17～6.02);LMP2基因多态性位点在两组人群中差异无统计学意义(P>0.05).在这两个位点所构建的单倍体型中,具有单倍体R-K的个体在两组人群中差异有统计学意义(P<0.01,OR=1.81).结论:LMP7基因的多态性与HBV感染有着显著的易感关联,虽然LMP2/LMP7基因多态性位点共同存在于单倍型时呈现一定拮抗作用,但结果提示,对于HBV感染的发生,LMP的多态性仍然是一个重要的易感危险因素.     

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。     

Hepatitis B prevalence in an unregistered prenatal population. Implications for neonatal therapy

STUDY OBJECTIVE--To evaluate the risk and associated cofactors for hepatitis B infection in inner-city pregnant women not registered for prenatal care. DESIGN--Fifteen-month survey of 208 patients not registered for prenatal care, compared with 1555 women registered for prenatal care during the same period. SETTING--An urban university hospital prenatal clinic and labor unit. RESULTS--Unregistered patients had a significantly higher rate of hepatitis B surface antigen positivity than patients who had registered with the clinic (6.7% vs 0.8%; P less than .0001). Unregistered patients with positive results of urine drug screening (46%) had a relative risk for seropositivity of 29.2%, compared with registered patients who did not have histories of illicit drug use (95% confidence interval, 25.9% to 32.4%), while registered patients with past histories of drug use had a relative risk of 6.7%, compared with the reference group that did not have histories of drug use (95% confidence interval, 1.8% to 24.0%). CONCLUSIONS--Among inner-city pregnant women not registered for prenatal care, a positive result of urine drug screening is a rapidly available marker for increased risk of hepatitis B surface antigen positivity. Infants born to unregistered women with positive results of urine drug screening before maternal hepatitis B surface antigen results are available may warrant empiric initiation of hepatitis B virus-specific prophylaxis.     

重组乙型肝炎疫苗(酿酒酵母)免疫新生儿13年后的效果观察

 目的 对重组乙肝疫苗的长期有效性进行研究。方法 乙肝母亲(35例)和健康母亲（100例)所生的新生儿按照0-1-6月的程序于1996年10月至1997年5月进行重组乙肝疫苗(酿酒酵母)免疫接种,免疫后13年(2010年)随访并进行乙肝相关血清学指标的检测和定量分析。结果 成功随访到101例少年。3.96%(4/101)的少年出现天然的乙肝病毒感染(即HBcAb阳性),其母亲均为具高感染性的乙肝感染者,其中1例同时为乙肝携带者。婴儿乙肝疫苗免疫13年后其anti-HBs阳性率为82.2%(83/101),其中起始疫苗应答者中anti-HBs阳性率为83.5%(76/91)。乙肝感染母亲和健康母亲所生少年anti-HBs阳性率无统计学差异,但母亲乙肝感染所生的少年anti-HBs水平较高。结论 重组乙肝疫苗(酿酒酵母)免疫后13年仍具有保护性,母亲乙肝感染长期影响着其子女处于较高的anti-HBs水平。