Baseline hepatitis B vaccination coverage among persons with diabetes before implementing a U.S. recommendation for vaccination

Background

Recent data suggest that adults with diabetes are at increased risk of incident hepatitis B infection and may suffer increased morbidity or mortality from chronic hepatitis B infection. In October 2011, the Advisory Committee on Immunization Practices (ACIP) recommended hepatitis B vaccination (HepB) for persons with diabetes aged 19–59 years and stated that persons with diabetes aged 60 years and older should be considered for vaccination.

Objective

To determine HepB coverage among persons with diabetes aged ≥19 years prior to implementation of the new ACIP recommendation and to determine predictors for vaccination.

Methods

We used the 2009 National Health Interview Survey to determine weighted proportions of self-reported HepB coverage (≥1 and ≥3 doses) among persons with diabetes aged ≥19 years. A multivariable logistic regression analysis was performed to determine factors independently associated with vaccination.

Results

Overall, 19.5% (95% CI: 17.4–21.6%) and 16.6% (14.7–18.6%) of persons with diabetes, aged ≥19 years, reported receiving ≥1 and ≥3 doses of HepB, respectively, compared with 30.3% (29.4–31.3%) and 26.5% (25.5–27.4%) among persons without diabetes. While unadjusted HepB coverage was higher among persons without diabetes, diabetes status was not associated with ≥1 or ≥3 dose vaccination. Among persons with diabetes, being a healthcare provider (OR 4.2, 2.5–7.0), ever tested for HIV (OR 2.6, 1.8–3.6), high-risk behaviors (OR 1.8, 1.0–3.4, P-value = 0.053) and having some college education (OR 1.7, 1.2–2.4) were all independently associated with vaccination.

Conclusion

HepB coverage among persons with diabetes is low. These data can be used to provide a baseline for measuring future progress toward vaccination of persons with diabetes.     

Progress in newborn hepatitis B vaccination by birth year cohorts-1998-2007, USA

Background

In 1999, the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (USPHS) issued a joint statement on thimerosal in vaccines, which advised clinicians to temporarily postpone the first dose of hepatitis B vaccine for infants born to hepatitis B surface antigen (HBsAg)-negative women. In 2005, the Advisory Committee on Immunization Practices (ACIP) updated the strategy to improve prevention of perinatal and early childhood hepatitis B virus (HBV) transmission.

Objectives

To evaluate the progress in hepatitis B birth dose vaccination coverage in birth year cohort from 1998 to 2007 and assess the impact of changes in ACIP recommendations on the birth dose coverage.

Methods

Birth year cohort study of hepatitis B birth dose vaccination status of 200,865 children aged 19-35 months in the United States and by selected socio-demographic factors; percentage increases of hepatitis B birth dose vaccination coverage between two consecutive birth year cohorts from 1998 to 2007.

Results

From 1998 to 1999, hepatitis B birth dose vaccination coverage declined overall in the United States and among selected socio-demographic groups (P < 0.001). Conversely, from 1999 to 2007 hepatitis B birth dose vaccination coverage increased significantly by birth year cohort (P < 0.001), from approximately 30% in the 1999 birth year cohort to approximately 60% in the 2007 birth year cohort. The first significant increase in hepatitis B birth dose vaccination coverage occurred from 2000 to 2001 birth year cohort. Coverage increases ranged from 8.4% to 11.9% (P < 0.001) in the U.S. and across all socio-demographic strata. The second largest increase in hepatitis B birth dose vaccination coverage occurred from 2005 to 2006 birth year cohort in the U.S. and among almost all socio-demographic strata, ranging from 5.6% to 8.7% (P < 0.001). Forty-one of the 50 states and the District of Columbia (80%) in the U.S. had increases in hepatitis B birth dose vaccination coverage from 2005 to 2006 birth year cohort.

Conclusions

The United States has made substantial progress in increasing hepatitis B birth dose vaccination and recovered from coverage declines associated with temporary postponement of the birth dose in 1999. The hepatitis B birth dose coverage in the U.S. remains substantially below the Healthy People 2020 target of 85%.     

Implementing a national policy for hepatitis B birth dose vaccination in Philippines: lessons for improved delivery

Background

An estimated seven million Filipinos (10-12% of the population) are chronically infected with hepatitis B virus (HBV). Achieving high birth dose coverage with hepatitis B vaccine is critical for achieving the World Health Organization's Western Pacific Regional goal of reducing the prevalence of chronic HBV among children 5 years of age to <2% by 2012.

Methods

Seven months after the Philippines adopted a hepatitis B vaccine birth dose policy, hospitals with the highest number of deliveries were invited to participate in an assessment of implementation of the birth dose policy. Additionally, in metro Manila birth dose coverage was estimated before and after conducting a training workshop and supervisory follow-up for practitioners conducting home deliveries or deliveries at lying-in clinics.

Results

Of the country's largest 150 hospitals in terms of authorized bed capacity, 85 (56%) were included in this assessment. These hospitals had 55,719 deliveries during July-September 2007. Of these, 54% infants had a documented birth dose; however, only 22% were vaccinated within 24 h of delivery. Having a copy of the hepatitis B vaccine vaccination policy (prevalence odds ratio [pOR] = 4.7, 95% confidence interval [CI] = 1.2-18.0), having standing orders pOR = 4.8, 95% CI = 1.3-18.1 and providing training pOR = 18.9, 95% CI = 5.3-67.0 were associated with >50% birth dose coverage in a hospital. In metro-Manila, regardless of place of birth, the training workshop and supervisory follow-up significantly improved hepatitis B vaccine administration within 24 h after birth, increasing from 19% before to 74% after the training workshop and follow-up.

Conclusions

Experience in the Philippines showed that actions by national, regional and health facility policy makers such as establishing national policies, distributing detailed and specific guidelines, conducting effective training and supervision, and having hospital standing orders substantially increased hepatitis B vaccine birth dose coverage.     

戊型肝炎疫苗和乙型肝炎疫苗联合接种的安全性及免疫原性研究

目的 分析戊型肝炎（戊肝）疫苗和乙型肝炎（乙肝）疫苗联合接种（联合接种）的安全性及免疫原性。方法 2015年9月至2016年12月在北京市朝阳区招募18~60岁健康受试者720人,将符合纳入标准的受试者随机化分为3组：联合接种（联合接种）组、乙肝疫苗接种组和戊肝疫苗接种组。3组均按照0、1、6个月程序接种,比较联合接种与单独接种的安全性及全程免疫1个月后的免疫原性。结果 接种疫苗的受试者共601人（戊肝疫苗接种组150人,乙肝疫苗接种组159人,联合接种组292人）。联合接种组的局部不良反应有疼痛（25.0%,73/292）、红（12.7%,37/292）、瘙痒（9.2%,27/292）、硬结（8.9%,26/292）、肿（8.2%,24/292）,全身不良反应有发热（7.2%,21/292）、头痛（5.8%,17/292）、肌肉痛（5.5%,16/292）、疲倦乏力（3.4%,10/292）。联合接种组除局部疼痛发生率高于单独接种组以外,其余不良反应与单独接种组均无明显差异,3组均无严重不良反应。全程接种1个月后,联合接种组的HBsAb阳转率、抗体几何平均浓度（GMC）非劣效于乙肝疫苗接种组（94.2%比93.8%,611.6 WU/ml比745.1 WU/ml）,HEV IgG抗体阳转率、GMC非劣效于戊肝疫苗接种组（98.8%比100.0%,11.0 WU/ml比18.0 WU/ml）。结论 联合接种具有良好的安全性和免疫原性,建议肝炎易感人群联合接种戊、乙肝疫苗,更好地保护肝脏。     

Prevalence of hepatitis B markers in the population of catalonia (Spain). Rationale for universal vaccination of adolescents

The prevalence of hepatitis B markers was determined in a representative sample of the general population of Catalonia (Spain). HBsAg was found in 0.5% of children (less than 15 years of age) and in 1.7% of adults (more than 15 years of age), and anti HBs in 1.6% and 18%, respecitvely. Age-specific prevalence for both markers showed a low risk for hepatitis B before puberty, and a progressive rise since adolescence, suggesting that perinatal transmission and horizontal transmission in children are relatively uncommon in Spain. Prevalence of hepatitis B markers was significantly higher among subjects with low education level, residing in an urban area and born outside Catalonia, but in the stratified analysis, a statistical significant difference was only maintained in the prevalence of HBV markers between those who live in urban and rural areas, and between those who were born outside Catalonia and in Catalonia. These data may be used as a basis for a strategy of hepatitis B prevention in Spain which include universal vaccination of adolescents, passive-active immunization of newborns to HBsAg positive mothers and vaccination of susceptible adults subjects from high-risk groups.Preventive Medicine Unit.Liver Unit.Corresponding author.     

Long term observation of the effect of intradermal hepatitis B vaccination on mentally retarded patients

Sixty-two patients of two institutions for mentally retarded patients were immunized intradermally with 4 ug doses of plasma-derived hepatitis B vaccine made in Japan, initially at month 0,1, and 6. The three vaccinations induced antibodies in 93.5% (90.9% in those with Down's syndrome (DS), 94.1% in other forms of mental retardation (OMR)) of the vaccinees within 9 months after the first injection, and the percentage of geometric mean titers of antibody above 10 mIU/ml was 89.3% (81.8% DS, 84.3% OMR) within 9 months. Within 2 years, the seroconversion rate showed a significantly higher decrease in subjects with DS (54.5%) than in OMR (86.3%), and the percentage of vaccinees with above 10 mIU/ml also showed a significantly higher decrease in subjects with DS (36.4%) than in those with OMR (74.5%) (p < 0.05). In the OMR patients, the antibody response persisted for 2 years, decreased remarkedly in the DS patients.Corresponding author.     

甘肃省乙肝疫苗纳入计划免疫和安全注射基层强化培训效果评估

目的了解乙肝疫苗纳入计划免疫和安全注射强化培训情况及评价培训效果。方法随机抽取评估县、乡、村，采取收集调查问卷、定性访谈形式、观察自毁型注射器使用、相关知识考试测评的方法对曾参加培训的乡、村级计划免疫工作人员进行培训评估工作。结果本次培训活动的人员共488人，乡村级培训覆盖率91．39％。60人参加问卷调查，普遍认为成人参与式培训方法生动，可提高学习积极性，培训教材内容基本满足基层的需要。经过强化培训后，理论水平有大幅度提高。大于80分的比例由强化培训前的5．11％上升到79．33％。影响培训效果的主要影响因素排序：行政部门领导对计划免疫培训工作重视；资金投入；师资水平培训方式（成人参与式）；教具、教材的选择等。结论成人参与式培训方法能有效提高基层人员的实际工作能力，值得推广。     

启东乙型肝炎干预研究:2013年随访人群HBV感染及慢性肝病现患调查

目的 分析新生儿接种乙型肝炎(乙肝)疫苗人群在达到婚配年龄后罹患慢性乙肝、肝硬化的远期保护作用。方法 2013年1-10月采用横断面调查方法,对启东乙肝干预研究(QHBIS)的研究对象分层随机抽样,并行ALT、HBV感染血清学标志物(HBsAg、HBeAg、抗-HBs、抗-HBc、抗-HBe)检测及肝胆B超检查。计算HBV感染血清学标志物各指标的阳性率,慢性乙肝及肝硬化的患病率,疫苗组及对照组人群按性别分层后, χ²检验比较各组间率的差异。结果 共获得新生儿乙肝疫苗接种组(疫苗组)4 421人和对照组3 880人,平均年龄分别为(25.59±1.84)岁和(26.61±2.24)岁。疫苗组HBsAg、单独抗-HBs、抗-HBc、HBeAg、抗-HBe阳性率分别为2.38%、37.73%、3.78%、0.57%、2.15%,对照组分别为9.02%、29.41%、16.83%、2.73%、8.87%,两组间血清学标志物各指标的差异均有统计学意义(P <0.05)。疫苗组慢性乙肝活动期、肝纤维化及肝硬化患病率分别为0.45%和0.16%,对照组分别为1.29%和0.39%,组间差异均有统计学意义(P <0.05)。按性别分层后,疫苗组男性慢性乙肝活动期患病率高于女性,差异有统计学意义(P <0.05);在对照组,不管是慢性乙肝活动期患病率还是肝纤维化及肝硬化患病率,男性均高于女性,差异有统计学意义(P <0.05)。结论 新生儿接种乙肝疫苗对慢性HBV感染的保护作用可延长至婚配年龄后,而不同性别人群慢性乙肝与肝硬化现患保护作用的差异值得进一步研究。     

A reduction in chronic hepatitis B virus infection prevalence among children in Vietnam demonstrates the importance of vaccination

Background

Vietnam has high endemic hepatitis B virus infection with >8% of adults estimated to have chronic infection. Hepatitis B vaccine was first introduced in the national childhood immunization program in 1997 in high-risk areas, expanded nationwide in 2002, and included birth dose vaccination in 2003. This survey aimed to assess the impact of Vietnam's vaccination programme by estimating the prevalence of hepatitis B surface antigen (HBsAg) among children born during 2000–2008.

Methods

This nationally representative cross-sectional survey sampled children based on a stratified three-stage cluster design. Demographic and vaccination data were collected along with a whole blood specimen that was collected and interpreted in the field with a point-of-care HBsAg test.

Results

A total of 6,949 children were included in the survey analyses. The overall HBsAg prevalence among surveyed children was 2.70% (95% confidence interval (CI): 2.20–3.30). However, HBsAg prevalence was significantly higher among children born in 2000–2003 (3.64%) compared to children born 2007–2008 (1.64%) (prevalence ratio (PR: 2.22, CI 1.55–3.18)). Among all children included in the survey, unadjusted HBsAg prevalence among children with ≥3 doses of hepatitis B vaccine including a birth dose (1.75%) was significantly lower than among children with ≥3 doses of hepatitis B vaccine but lacked a birth dose (2.98%) (PR: 1.71, CI: 1.00–2.91) and significantly lower than among unvaccinated children (3.47%) (PR: 1.99, CI: 1.15–3.45). Infants receiving hepatitis B vaccine >7 days after birth had significantly higher HBsAg prevalence (3.20%) than those vaccinated 0-1 day after birth (1.52%) (PR: 2.09, CI: 1.27–3.46).

Conclusion

Childhood chronic HBV infection prevalence has been markedly reduced in Vietnam due to vaccination. Further strengthening of timely birth dose vaccination will be important for reducing chronic HBV infection prevalence of under 5 children to <1%, a national and Western Pacific regional hepatitis B control goal.     

Immune response in infants after universal high-dose hepatitis B vaccination: A community-based study in Beijing,China

BackgroundVaccination of infants beginning at birth is recommended to prevent Hepatitis B virus (HBV) infection in China. Compared to 5 μg/dose vaccine administered in other regions in China, a three-dose HB recombinant yeast vaccine at 10 μg/dose has been administered for infants within 24 h after birth, 1 month and 6 months of age in Beijing since 2006. In a community-based retrospective cohort study, factors influencing immunologic vaccine response were evaluated.MethodsA total of 3670 infants who completed a 3-dose 10 μg recombinant HB vaccine regimen and born to hepatitis B antigen negative mothers were included. The effect on anti-HBs titers of maternal nutrient status, infants’ birth condition, growth factors, timeliness of vaccination, dosing interval and the interval until post-vaccination serologic testing (PVST) were evaluated.ResultsA total of 3666 infants with no markers of HBV infection were included in analysis. The mean anti-HB titers were 1767.17 mIU/ml. Only 16.9% of the infants completed their PVST within 30–59 days after the final dose of vaccination. Multivariate linear regression analysis showed that delay in PVST (β = −0.097, p < 0.0001) and maternal folic acid supplementation (β = 0.067, p = 0.002) were associated with log-transformed anti-HB titers. Also a trend toward significant association was observed between the calcium supplementation of infants and log-transformed anti-HBs titers (β = 0.062, p = 0.057). Longer interval between dose 2 and dose 3 was not observed to increase the anti-HB titers after cofactors adjustment.ConclusionsOur findings illustrate the importance of timing of PVST to avoid unnecessary revaccination. Multi-center large cohort studies should verify the effect and magnitude of folate and calcium supplementation on HB vaccine response.     

Vaccination against hepatitis A and B in persons subject to homelessness in inner Sydney: vaccine acceptance,completion rates and immunogenicity

Objectives: To determine acceptance, completion rates and immunogenicity of the standard vaccination schedule for hepatitis A (HAV) and B (HBV) in persons subject to homelessness. Methods: A convenience sample of clients (n=201) attending a medical clinic for homeless and disadvantaged persons in Sydney was enrolled. Serological screening for HAV and HBV was undertaken. An appropriate vaccination program was instituted. Post‐vaccination serology determined serological response. Results: Although many clients had serological evidence of past infection, at least 138 (69%) clients had the potential to benefit from vaccination. For hepatitis A and B vaccinations, completion rates were 73% (73 of 100 clients) and 75% (69 of 92 clients), respectively; after vaccination, protective antibody was found in 98.2% (56 of 57) and 72% (36 of 50) of clients, respectively. Conclusion: A successful vaccination program can be mounted with a vulnerable population. We consider a clinic with a well‐established history of acceptance and utilisation by the target group; a low staff turnover and regular clientele; inclusion of vaccination as part of routine client care; and counselling (part of pre‐ and post‐serological testing) essential components in achieving good vaccination completion rates.     

Probabilistic cost-effectiveness analysis of the long-term effect of universal hepatitis B vaccination: An experience from Taiwan with high hepatitis B virus infection and Hepatitis B e Antigen positive prevalence

Aim

To assess cost-effectiveness of hepatitis B virus (HBV) vaccination strategies from health care payer and societal perspectives, focusing on the long-term effect, in Taiwan where prevalence of HBV and Hepatitis B e Antigen (HBeAg) is high.

Methods

A decision analysis was performed to compare total costs and effectiveness between two vaccination strategies: universal vaccination and no-vaccination. The Markov process was defined as a series of states including acute HBV infection, asymptomatic carrier, chronic hepatitis, compensated and decompensated liver cirrhosis, hepatoma, and death. Direct and indirect costs were also imputed based on estimates. The incremental cost-effectiveness ratio (ICER) per life-year gained and quality-adjusted life years gained were calculated at a 3% discount rate. By assigning a series of specific distributions to each parameter, a probabilistic cost-effective analysis using Monte Carlo simulation was conducted to yield 5000 ICER replicates.

Results

The effectiveness of a universal vaccination program for reducing hepatocellular carcinoma cases and deaths was approximately 86%. The average life years gained per subject as a result of such a universal vaccination was 3.9. The vaccination program dominated over a no-vaccination program (less cost and more effectiveness).

Conclusions

A universal vaccination program against hepatitis B infection is not only effective for reducing long-term sequelae but is also a cost-saving primary preventive strategy, which supports a universal infant immunization in endemic area with high prevalence of HBV and HBeAg.     

Declining prevalence of hepatitis B virus infection in Catalonia (Spain) 12 years after the introduction of universal vaccination

AIMS: To analyze the prevalence of hepatitis B virus infection markers and hepatitis B vaccination in a representative sample of the juvenile and adult population of Catalonia and to evaluate the changes with respect to seroepidemiological surveys carried out in 1989 and 1996. DESIGN: In all subjects anti-HBc and anti-HBs antibodies and HBsAg were determined using an ELISA test. The possible association between sociodemographic variables and the prevalence of markers was analysed by calculating the adjusted odd ratio (simple logistic regression). SETTING: The study was carried out in 2002 in representative samples of the juvenile (5-14 years) and adult population (>or= 15 years) of Catalonia (Spain). MAIN RESULTS: In 2002 the global prevalence of HBsAg+ was 0.7% (95% CI: 0.4-1.0) and that of anti-HBc+ 8.7% (95% CI: 7.6-9.8), values higher than those obtained in 1989 of 1.5% (95% CI: 1.0-2.1) and 15.6 (95% CI: 13.9-17.3). The prevalence of markers of infection increased with age. The only sociodemographic variable significantly associated with the prevalence of hepatitis B virus infection was the place of birth. The risk of infection was twice as high in subjects born outside Catalonia (p<0.01), adjusted OR 2.0 (95% CI: 1.34-2.98) compared with those born in Catalonia. CONCLUSIONS: The results of this study show that the prevalence of hepatitis B virus infection (anti-HBc+) in Catalonia (Spain) is currently the lowest it has ever been and suggest that there has been a change in the pattern of endemicity of hepatitis B virus infection in Catalonia, which has become a country of low endemicity.     

Comparison of the implementation of human papillomavirus and hepatitis B vaccination programs in the United States: Implications for future vaccines

Vaccines for two viruses which cause cancer, human papillomavirus (HPV) and hepatitis B virus (HBV), are recommended for all children in the United States. Numerous parallels exist between the two vaccines in addition to their roles in cancer prevention, including transmission through sexual contact, multiple doses needed for series completion, and vaccine administration in adolescence for HPV and in the initial phase of the HBV vaccination program. All of these factors were viewed as potential barriers to achieving high rates of coverage, yet the ultimate success of the HBV vaccination program led to predictions that similarly high rates of coverage could be achieved for the HPV vaccine. However, currently, only the recommendation for HBV vaccination is supported by mandates for school entry in most states. Uptake of the HPV vaccine has lagged far behind U.S. goals for public health promotion. The aim of this paper is to examine factors which may account for the divergent pathways of the two vaccines. Four main factors are identified: logistical challenges of vaccine administration, attitudes of parents and healthcare providers, safety concerns, and cost. For each factor examined, recommendations are offered to confront similar barriers likely to arise for future vaccines. The authors conclude that gender-neutral state mandates coupled with school-located vaccination programs, stronger gender-neutral messaging from pharmaceutical companies and healthcare providers, and younger age of vaccine administration, if approved, present the most promising approaches to improving uptake of the HPV vaccine, and similar vaccines down the road.     

Cholecalciferol supplementation to improve the hepatitis B vaccination response in hemodialysis patients: A first randomized open label pilot study (DeVitaHep)

BackgroundPatients with advanced chronic kidney disease should be vaccinated against hepatitis B. In observational studies vitamin D insufficiency is associated with a reduced seroconversion rate. The effect of cholecalciferol supplementation on hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency is unknown.MethodsIn this randomized open label pilot study 40 unvaccinated haemodialysis patients with 25(OH)D insufficiency (<30 ng/mL) were enrolled. In the supplementation group, we administered cholecalciferol orally in a dose of 28,000 IU weekly for a maximum of 12 weeks. Hepatitis B vaccination (HBvaxPRO 40 µg i.m. months 0, 1, 6) was performed after achieving a 25(OH)D level >30 ng/mL or after completing three months of supplementation despite failure to achieve the target level. In the control group, patients were vaccinated immediately after randomization. Anti-hepatitis B-antibody titer (anti-HBs) was measured eight weeks after completing the vaccination course.ResultsThirty-seven (26 male, 11 female) patients aged 65 (13.5) years underwent randomization with 17 patients allocated to the control group and 20 patients included in the supplementation group. After 12 weeks of cholecalciferol supplementation, mean (SD) 25(OH)D concentration increased from 15.0 (8.0) to 31.0 (7.1) ng/mL, but remained unchanged in the control group (14.0 (7.1) to 11.6 (7.5) mg/mL). Neither the number of patients with seroconversion (anti-HBs titer ≥ 10 IU/L; n = 6 (35.3%) vs n = 3 (27.3%), p = 0.704), nor the number of patients with seroprotection (anti-HBs titer >100 IU/L; n = 4 (23.5%) vs n = 2 (18.2%) differed between treatment groups. Cholecalciferol supplementation was safe without treatment-related adverse events.ConclusionIn this small pilot study, high-dose oral cholecalciferol supplementation did not improve the hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency.This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26).     

中国乙型肝炎疫苗免疫预防效果和现行策略的经济学和决策学评估

目的 对中国儿童乙型肝炎(乙肝)疫苗免疫预防14年(1992-2005年)效果评估和对现行的乙肝疫苗接种方案进行优化.方法 构建适合中国乙肝疫苗免疫预防实际效果评估和方案优化决策树模型,模型中参数根据相关研究文献或由专业机构提供.主要分析指标为成本效果比(CER)和效益成本比(BCR),用敏感度分析和阈值分析对各参数影响大小进行评估. 结果 14年间,中国直接和间接地用于新生儿乙肝疫苗接种总投入约为53.48亿元,而获得的总效益达2728.25亿元,即乙肝疫苗接种的净效益为2674.77亿元;同期由于疫苗接种避免发生HBV感染约6523万人,每预防一例HBV感染的费用为81.99元,但每投入1元获得的收益为51.01元.中国现行乙肝疫苗接种采用新生儿3剂5 μg,并于出生24 h内完成第一针;对孕妇筛检HBsAg,阳性者新生儿加注一剂乙肝免疫球蛋白(HBIG)均为最优方案.而新生儿以外的1～60岁人群乙肝疫苗接种仍町以获得正效益,尤其是在20岁以前接种效益更明显;但"筛检后再接种"均优于"直接接种". 结论 中国既往14年间在新生儿中实行的乙肝疫苗接种策略,从实际的预防效果和投资的经济效益看都是值得的;现行的新生儿优先接种并保持高覆盖率的策略仍为合理方案.     

Considerations for estimating real-world outcomes and value in vaccination: A case study with adult hepatitis B virus vaccination

BackgroundIn the absence of field efficacy studies, estimating the real-world effectiveness of vaccines may consider immunogenicity from randomized controlled clinical trials and real-world adherence. Combining seroprotection rates (SPRs) with regimen completion rates gives an estimate of an effective vaccine protection rate (eVPR), which can be leveraged to evaluate real-world cost-effectiveness by linking it with vaccine costs to estimate the cost-per-protected patient (CPP).MethodsThis study evaluated eVPR and CPP as estimates of vaccine clinical- and cost-effectiveness of two-dose (HepB-CpG) and three-dose (HepB-Alum) hepatitis B virus (HBV) vaccines in the general adult population and a subpopulation with diabetes mellitus. eVPR was calculated from head-to-head SPR data from phase 3 clinical trials directly comparing HepB-CpG and HepB-Alum vaccine regimens and real-world head-to-head adherence data. CPP was calculated as the average cost of each regimen divided by eVPR.ResultsHigher eVPR in the adult population was achieved with HepB-CpG (68.0%) versus HepB-Alum (41.6%), reflecting the combination of higher SPR and vaccine regimen completion. The CPP for HepB-CpG ($331.31) was $45.67 (95% CI: $36.66, $55.19) less than HepB-Alum ($377.09). Greater savings were observed among persons with diabetes, with CPP $149.60 (95% CI: $80.29, $195.63) lower with HepB-CpG ($367.57) than HepB-Alum ($517.37).ConclusionsMetrics estimating vaccine real-world effectiveness and value may guide informed decisions in vaccine selection. For example, using eVPR and CPP, HepB-CpG represents a more effective, value-advantaged approach than HepB-Alum toward reducing HBV infection.     

Screening for hepatitis B virus and accelerated vaccination schedule in prison: A pilot multicenter study

Background and Aim

Vaccine against hepatitis B virus (HBV) is highly effective in preventing HBV infection. The aims of this study were to (1) increase the epidemiological knowledge on the impact of HBV in Tuscany region prisons by registering the results of serum screening on a clinical medical record and (2) increase the anti-HBV vaccination using an accelerated schedule.