Immunization of human hepatitis E viruses conferred protection against challenge by a camel hepatitis E virus

Dromedary camel hepatitis E virus is a novel HEV that belongs to the family Hepeviridae, and is classified as genotype 7 HEV (HEV-7). Since HEV-7 is transmitted from camels to humans and causes acute hepatitis E, this virus is a non-negligible pathogen for zoonosis, and a vaccine against HEV-7 infection is urgently needed. Here, we first intravenously inoculated HEV-7 to rhesus monkeys to explore the susceptibility, and we established an animal model. We then used virus-like particles (VLPs) of HEV-1 (HEV-1 VLPs) and HEV-3 (HEV-3 VLPs), a candidate hepatitis E vaccine, to intramuscularly inoculate rhesus monkeys. The monkeys elicited IgG antibody titers as high as >1:102,400 against heterologous HEV-7 without any adjuvants. The HEV-1 VLPs and HEV-3 VLPs-immunized monkeys were challenged intravenously with HEV-7, and they were protected completely from the infection, demonstrating that these VLPs could be a usable vaccine against HEV-7 infection. We also observed that HEV-7-infected rhesus monkeys did not show any liver damage during these experiments. Further efforts are necessary to establish an animal model for investigation of the pathogenesis of hepatitis E caused by HEV-7 infection.     

Host immune response to A(H1N1)pdm09 vaccination and infection: a one-year prospective study on six cohorts of subjects

Background

The long-term immunogenicity after novel vaccine against A(H1N1)pdm09 administration or natural infection has not been well investigated.

Methods

Six cohorts of subjects were followed up for over one year: one-dose A(H1N1)pdm09 vaccine recipient, A(H1N1)pdm09-seasonal trivalent vaccine recipients in different orders, confirmed A(H1N1)pdm09 patients without vaccination, with previous A(H1N1)pdm09 or seasonal influenza vaccination. Peripheral blood mononuclear cells and sera samples were collected at baseline and month 1, 2, 3, 7 and 14 after vaccination (infection). The immunogenicity was determined by hemagglutination-inhibition (HI) and B cell enzyme-linked immunospot (ELISPOT) assays.

Results

Single dose of A(H1N1)pdm09 vaccine elicited antibody titer of greater than 1:40 in 40% adults for 1 year and mean live of this adequate antibody was determined as 8.35 months. In contrast, responses after natural infections had lower peaking level and a relatively longer antibody duration, with estimated mean lives of 11.8 months. Pre-vaccination with the seasonal flu vaccine led to a significant reduction in HI titer to A(H1N1)pdm09 one month after vaccination, while pre-vaccination with A(H1N1)pdm09 had no effect on seasonal influenza vaccination. Seasonal flu vaccination followed by A(H1N1)pdm09 infection elicited boosting effect on antibody response against A(H1N1)pdm09. A similar memory B cell response was elicited from both vaccination and infection by ELISPOT assay.

Conclusions

The long-term decay of immunity for A(H1N1)pdm09 vaccine and natural infection indicates the need of revaccination after the host lose protection acquired from either vaccination or infection. Prior infection, rather than the pre-vaccination with seasonal influenza could act on the host immunity to elicit boosting effect on the A(H1N1)pdm09.     

Protection of pregnant mice,fetuses and neonates from lethality of H5N1 influenza viruses by maternal vaccination

The highly pathogenic H5N1 influenza viruses are one of candidates for the next pandemic. Information on protective immunity for pregnant animals by vaccination against the H5N1 influenza virus is limited. Here, we show that the immunization of pregnant mice with inactivated H5N1 influenza vaccine protects them, their fetuses, and their infant mice from H5N1 influenza viruses. Pregnant mice immunized with two doses of H5N1 influenza vaccine were protected from homologous infections of H5N1 influenza viruses with no viruses detected in fetuses, and that they were protected upto 30% from heterologous infections of H5N1 influenza viruses with viruses detected in fetuses. The infant mice born to mothers immunized with H5N1 influenza vaccine were fully protected from infections of H5N1 influenza viruses for upto 4 weeks of age. The protection of infant mice was closely related to the presence of IgG2a antibody in lung, heart, and rectum tissues. Our results suggest that maternal vaccination may be critical for protecting pregnant animals, their fetuses, and their infant mice from lethal infections of H5N1 influenza viruses.     

福建省戊型肝炎病毒感染的血清流行病学调查

目的了解福建省动物种群及人群中戊型肝炎病毒(HEV)的感染情况。方法收集猪、犬、乳牛、山羊和啮齿动物(黄胸鼠及褐家鼠)等5种与人类关系密切的哺乳动物血清标本共1151份,收集普通人群血清标本2209份,暴露人群血清标本1722份,应用ELISA检测抗-HEV IgG抗体。结果不同动物HEV感染率有差异(x2=406.25,P<0.01),其中猪的感染率为71.31%,散养家猪(70.00%-94.12%)HEV感染率高于大型专业养猪场(39.77%),不同生长期(≥4月龄)的猪其HEV感染率未见不同。普通人群HEV的阳性率为23.3%,暴露人群HEV阳性率为33.3%;暴露人群阳性率显著高于普通人群。在暴露人群中与鸡密切接触者,HEV的阳性率显著高于与猪密切接触者。HEV阳性率有随年龄的增长而上升的趋势,在普通人群中,男、女性HEV阳性率差异无统计学意义(P>0.05);但在暴露人群中男性HEV阳性率显著高于女性。结论猪和暴露人群HEV的感染率较高;与猪、鸡密切接触者HEV阳性率高于普通人群,证明了HEV可能是一种人兽共患病。     

Routine and pulse vaccination for Lassa virus could reduce high levels of endemic disease: A mathematical modelling study

Lassa fever is an acute viral illness caused by Lassa virus (LASV), a rodent-borne pathogen. LASV is endemic to much of Sub-Saharan West Africa, where seasonal outbreaks cause significant morbidity and mortality. Increased global awareness of LASV has led to development of improved diagnostic tests, treatments and vaccines. As vaccine candidates are trialled, it is essential to assess the potential outcomes of introducing a LASV vaccination program in endemic regions. This study investigates the potential outcomes of routine and pulse vaccination strategies using a deterministic mathematical model that captures seasonal LASV transmission between rodents and humans. For plausible parameter values, we find that immunization of 40% of infants at 70% vaccine effectiveness achieves a population-level reduction in infectious case numbers of 30%, while coverage of 60% at 90% vaccine effectiveness achieves a 56% reduction. Similar reductions can be achieved more rapidly via population-wide pulse vaccination at 11% coverage (30% reduction at 70% effectiveness) or 23% coverage (56% reduction at 90% effectiveness) repeated every 10 years. Similar pulse vaccine doses delivered at reduced frequency, but increased coverage achieves a greater reduction in infectious cases. Findings around infant vaccination are sensitive to our assumption that immunity is life-long, while pulse-vaccination has only slightly reduced effect if immunity lasts 10–30 years. An effective LASV vaccination program would incorporate pulse vaccination in addition to routine childhood immunization to limit disease. Estimates of feasible vaccine coverage and effectiveness are needed to fully quantify the likely benefits of a vaccination program in LASV endemic regions.     

Use of GFP-expressing influenza viruses for the detection of influenza virus A/H5N1 neutralizing antibodies

The hemagglutination inhibition (HI) assay is used most commonly for the detection of antibodies to influenza viruses. However, for the detection of antibodies to avian influenza viruses of the H5N1 subtype either induced by infection or by vaccination, the HI assay is insensitive. Therefore, the virus neutralization (VN) assay has become the method of choice to detect human serum antibodies directed to these viruses. However, this assay requires a second assay for the detection of residual virus replication, which makes it laborious to perform and less suitable for high throughput testing of large numbers of samples. Here we describe an alternative method for the detection of these antibodies, which is based on the use of reporter viruses that express the green fluorescent protein (GFP) upon infection of target cells. GFP-expressing viruses were generated carrying the HA of a variety of antigenically distinct H5N1 influenza viruses. The method proved easy to perform and could be carried out rapidly. Using a panel of antisera raised against H5N1 influenza viruses, the assay based on GFP expressing viruses was compared with the classical virus neutralization assay and the hemagglutination inhibition assay. In general, the results obtained in these assays correlated well. It was concluded that the assay based on the reporter viruses is an attractive alternative for the classical virus neutralization assay and suitable for large sero-epidemiological studies or for the assessment of vaccine efficacy in clinical trials.     

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.     

Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey

Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course.Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas.Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the relationship between antibody titre and protection.     

Humoral immunity 10 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine

Persistence of antibodies after a single dose of Tdap vaccine (tetanus, diphtheria, and 5-component acellular pertussis vaccine) was evaluated in a follow-up study of adolescents (N=324) and adults (N=644) who had received Tdap in earlier clinical trials. Outcome measures were seroprotection (tetanus and diphtheria) or seropositivity (pertussis) and geometric mean concentrations. Humoral immune responses to all antigens were robust 1 month after initial immunization, decreased at subsequent measurements, but continued to exceed pre-immunization levels 1, 3, 5, and 10 years later. Protective levels of diphtheria and tetanus antitoxin persisted in 99.3% of adolescents 10 years after a booster dose of Tdap. Seropositivity to 1 or more pertussis antigens also persisted in most adolescents for 10 years. Although tetanus antitoxin responses were similar in adults to those observed in adolescents, diphtheria antitoxin titers were lower, reflecting the fact that a smaller proportion of adults had received diphtheria toxoid in the previous 10 years compared to adolescents. These data will contribute to the selection of the optimal interval for repeat doses of Tdap.     

Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: Meeting at the Crossroads

In May 2009 the National Institute of Allergy and Infectious Diseases hosted a workshop on serologic assays that support vaccine efficacy evaluations. The meeting promoted exchange of ideas among investigators from varying disciplines who are working on anti-infectious agent vaccines at different stages of development. The presentations and discussions at the workshop illustrated the challenges common across various pathogens with recurring themes: (1) A thorough understanding of the science regarding the pathogen and the host response to disease and immunization is fundamental to assay selection. (2) The intended use of the immunoassay data must be clearly defined to ensure appropriate specificity, accuracy, and precision; a laboratory must also commit resources to assure data quality and reliability. (3) During vaccine development, an immunoassay may evolve with respect to quality, purpose, and degree of standardization, and, in some cases, must be changed or replaced as data are accumulated. (4) Collaboration on standardized reagents and methods, harmonization efforts, and multidisciplinary teams facilitate consistent generation of quality data. This report provides guidance for effective development and utilization of immunoassays based on the lessons learned from currently licensed vaccines. Investigators are encouraged to create additional opportunities for scientific exchange, noting that the discussed themes are relevant for immunoassays used for other purposes such as therapeutics and diagnostics.     

The immune response to rabies virus infection and vaccination

Infection with rabies virus causes encephalitis in humans that has a case fatality rate of almost 100%. This inability to resolve infection is surprising since both pre-exposure vaccination and, if given promptly, post-exposure vaccination is highly effective at preventing encephalitic disease. The principal immunological correlate of protection produced by vaccination is neutralizing antibody. T-helper cells contribute to the development of immunity whereas cytotoxic T cells do not appear to play a role in protection and may actually be detrimental to the host. One reason for a failure to protect in humans may be the poor immunological response the virus provokes, despite the period between exposure to virus and the development of disease being measured in months. Few individuals have measurable neutralizing antibody on presentation with disease, although in many cases this develops as symptoms become more severe. Furthermore, when antibody is detected in serum it rarely appears in cerebrospinal fluid suggesting limited penetration into the CNS, the site where it is most needed. The role of the modest mononuclear cell infiltrate into the brain parenchyma is unclear. Some studies suggest the virus can suppress cell-mediated immunity early during the infection although there is little mechanistic evidence to support this beyond suppression of intracellular interferon production by the viral phosphoprotein. In contrast, levels of antibody in the CNS correlate to the peak virus production within the CNS. Here we review the current understanding of immune responses to rabies infection and vaccination against this disease. This article identifies a need to understand how rabies antigens are initially presented and how this can influence the subsequent development of antibody responses. This could help identify ways in which the response to prophylactic vaccination can be enhanced and how the natural immune response to infection can be boosted to combat neuroinvasion.     

Long-term immunity and immune response to a booster dose following vaccination with the inactivated Japanese encephalitis vaccine IXIARO,IC51

IC51 (IXIARO^®, JESPECT^®) is a recently approved prophylactic Japanese encephalitis virus vaccine with a two-vaccine primary immunization regimen. In this phase 3 trial, after primary immunization with a Day 0/28 dose schedule, seroprotection rates were 83%, 58% and 48% at Month 6, Month 12 and Month 24, respectively. A booster dose at Month 11 and/or Month 23 in subjects with neutralizing antibody titers below the limit of detection (defined as a serum dilution giving a 50% reduction of plaque counts in a plaque reduction neutralization test [PRNT50] < 1:10) led to 100% seroconversion. After a single-dose immunization (incomplete primary immunization), only 9% of subjects were seroprotected at Month 6; however, a booster dose at Month 11 led to seroconversion in 99% of subjects. Hence, subjects with incomplete primary immunization can complete their schedule within at least 11 months.     

The protective rate of the feline immunodeficiency virus vaccine: An Australian field study

A case-control field study was undertaken to determine the level of protection conferred to client-owned cats in Australia against feline immunodeficiency virus (FIV) using a commercial vaccine. 440 cats with outdoor access from five Australian states/territories underwent testing, comprising 139 potential cases (complete course of primary FIV vaccinations and annual boosters for three or more years), and 301 potential controls (age, sex and postcode matched FIV-unvaccinated cats). FIV status was determined using a combination of antibody testing (using point-of-care test kits) and nucleic acid amplification, as well as virus isolation in cases where results were discordant and in all suspected FIV-vaccinated/FIV-infected cats (‘vaccine breakthroughs’). Stringent inclusion criteria were applied to both ‘cases’ and ‘controls’; 89 FIV-vaccinated cats and 212 FIV-unvaccinated cats ultimately satisfied the inclusion criteria. Five vaccine breakthroughs (5/89; 6%), and 25 FIV-infected controls (25/212; 12%) were identified, giving a vaccine protective rate of 56% (95% CI −20 to 84). The difference in FIV prevalence rates between the two groups was not significant (P = 0.14). Findings from this study raise doubt concerning the efficacy of Fel-O-Vax FIV® under field conditions. Screening for FIV infection may be prudent before annual FIV re-vaccination and for sick FIV-vaccinated cats. Owners should not rely on vaccination alone to protect cats against the risk of acquiring FIV infection; other measures such as cat curfews, the use of ‘modular pet parks’ or keeping cats exclusively indoors, are recommended.     

Long-term follow-up of a vaccination program for infants born to HBsAg-positive mothers in Stockholm County,Sweden

We investigated the long-term antibody response to hepatitis B virus (HBV) vaccination in babies born to chronically infected mothers. They received one dose of monovalent HBV vaccination at birth and one month of age, followed by 3 doses of hexavalent vaccine including an HBV component at ages 3, 5, and 12 months, respectively, with a very high percentage of protective anti-HBs levels at 13 months. At the age of 8–12 years, 56 out of 68 children (82%) had protective levels of anti-HBs, two had signs of anti-HBc seroconversion without any history of clinical disease and none had ongoing infection. A small subgroup was retested after one booster dose, in all resulting in increase in anti-HBs from below 10 IU/L to levels corresponding to protective immunity. We conclude that this vaccination strategy is effective throughout the first decade of life in avoiding chronic infection and in maintaining a good serological response.     

Development and characterization of cold-adapted viruses for use as live virus vaccines

Representative viruses from twelve RNA and two DNA virus genera have been successfully adapted to growth at sub-optimal temperature (cold-adapted). In almost every case, there was a correlation between acquisition of the cold-adaptation phenotype and loss of virulence in the normal host whether animal or man. Overall, the best method of cold adaptation to develop a live virus vaccine line appeared to be a stepwise lowering of the growth temperature allowing time for multiple lesions to occur and/or be selected. In addition, the starting virus should be a recent isolate not as yet adapted to a tissue culture host and the cold-adaptation process should then occur in a host heterologous to the virus' normal host. These viruses have been reviewed in the light of their cold-adaptation method and successful production of an attenuated line as virus vaccine candidate. Finally, detailed information is presented for the cold-adaptation process in influenza virus.     

Heightened adaptive immune responses following vaccination with a temperature-sensitive, live-attenuated influenza virus compared to adjuvanted, whole-inactivated virus in pigs

In the United States there are currently two influenza vaccine platforms approved for use in humans-conventional inactivated virus and live-attenuated influenza virus (LAIV). One of the major challenges for influenza A virus (IAV) vaccination is designing a platform that provides protection across strains. Pandemic H1N1 (pH1N1) IAV swept the globe in 2009 and crossed the species barrier, infecting swine in several countries. Pigs are a natural host for IAV and serve as a model for evaluating immune responses following vaccination and challenge. Recently, a temperature-sensitive (ts) LAIV was developed by introducing modifications in the polymerase genes of a swine-like triple reassortant (tr) virus and when paired with pandemic HA and NA, provided sterilizing immunity upon intratracheal challenge with virulent pH1N1 virus. The utility of a ts LAIV is expanded in this report to show vaccination of pigs induced a cell-mediated immune response characterized by an increased number of antigen-specific IFN-secreting cells and expanded T cell populations when compared to pigs vaccinated with a whole inactivated virus (WIV) vaccine. Following challenge, there was a significant increase in the percentage of proliferating lymphocytes in the LAIV group compared to the WIV group following restimulation with pH1N1 in vitro. Also, there was an increase in the percentage of CD4/CD8 double-positive memory T cells in LAIV vaccinated pigs compared to WIV vaccinated pigs. Hemagglutination inhibition and serum neutralization titers were significantly higher in the LAIV-vaccinated pigs compared to the WIV vaccinated pigs following the initial dose of vaccine. Taken together, these results indicate the ts LAIV vaccine, generated from a triple reassortant IAV, elicits greater cell-mediated and humoral immune responses in pigs.     

Long-term safety and serologic response to measles, mumps, and rubella vaccination in HIV-1 infected adults

We analyzed HIV viral load (VL) and CD4 count changes, and antibody responses following MMR vaccination of individuals in the U.S. Military HIV Natural History Study cohort. Cases receiving at least one dose of MMR vaccine after HIV diagnosis were matched 1:2 to HIV-positive controls not receiving the vaccine. Baseline was defined as time of vaccination for cases and indexed and matched to the time post-HIV diagnosis for controls. Changes in CD4 count and VL at 6, 12, 18 and 24 months were compared between cases and controls using a general linear model. Available sera from cases were tested for MMR seropositivity at baseline and post-vaccination at 6, 12, 18, and 24 months. Overall mean CD4 count change from baseline through 24 months was 20 (±23) cells/μL greater for cases than controls (p = 0.39). Similar non-significant changes in CD4 cell count were seen in the subset of those not on HAART at baseline. VL changes were small and similar between groups (mean differential change −0.04 (±0.18) log₁₀ copies/mL; p = 0.84). Of 21 vaccinated participants with baseline serologic testing, 14 (67%) were reactive to measles, 19 (91%) to mumps, and 20 (95%) to rubella. Three (43%) of 7 participants nonreactive to measles developed measles IgG; for mumps, 1 (50%) of 2 developed mumps IgG; for rubella, 1 (100%) developed rubella IgG. MMR vaccination did not result in detrimental immunologic or virologic changes through 24 months post-vaccination.     

Informing randomized clinical trials of respiratory syncytial virus vaccination during pregnancy to prevent recurrent childhood wheezing: A sample size analysis

BackgroundEarly RSV illness is associated with wheeze-associated disorders in childhood. Candidate respiratory syncytial virus (RSV) vaccines may prevent acute RSV illness in infants. We investigated the feasibility of maternal RSV vaccine trials to demonstrate reductions in recurrent childhood wheezing in general paediatric populations.MethodsWe calculated vaccine trial effect sizes that depended on vaccine efficacy, allocation ratio, rate of early severe RSV illness, risk of recurrent wheezing at age 3, and increased risk of RSV infection on recurrent wheezing. Model inputs came from systematic reviews and meta-analyses. For each combination of inputs, we estimated the sample size required to detect the effect of vaccination on recurrent wheezing.ResultsThere were 81 scenarios with 1:1 allocation ratio. Risk ratios between vaccination and recurrent wheezing ranged from 0.9 to 1.0 for 70% of the scenarios. Among the 57 more plausible scenarios, the lowest sample size required to detect significant reductions in recurrent wheezing was 6196 mother-infant pairs per trial arm; however, 75% and 47% of plausible scenarios required >31,060 and >100,000 mother-infant pairs per trial arm, respectively. Studies with asthma endpoints at age 5 will likely need to be larger.DiscussionClinical efficacy trials of candidate maternal RSV vaccines undertaken for licensure are unlikely to demonstrate an effect on recurrent wheezing illness due to the large sample sizes likely needed to demonstrate a significant effect. Further efforts are needed to plan for alternative study designs to estimate the impact of maternal RSV vaccine programs on recurrent childhood wheezing in general populations.     

丁型肝炎病毒感染标志物在乙型肝炎病毒感染者中的检测研究

目的 通过检测和分析乙型肝炎病毒(HBV)感染者中丁型肝炎病毒(HDV)感染标志物的分布状况及HBV感染相关指标关联性分析,阐述HDV感染标志物的检测在HBV-HDV重叠感染患者中的临床意义.方法 收集HBV感染者的一般资料和血样,通过酶联免疫分析法检测五项血清HBV感染免疫学标志物指标、HDVAg和Anti-HDV,结合临床诊断和生化指标进行分析,探讨指标间相关性.结果 收集确诊HBV感染者样本346例,其中乙型肝炎病毒携带者62例占17.9％,急性乙型肝炎8例占2.3％,慢性乙型肝炎147例占42.5％,慢性重型乙型肝炎4例占1.2％,乙型肝炎后肝硬化125例占36.1％;检出总体HDV感染率为4.6％,男性显著高于女性,慢性重型乙型肝炎的HDV感染率最高,为25.0％,HDV感染者肝损伤发生率较高.结论 重症肝病病例的HDV感染显著增高,提示HDV感染与肝病的严重程度相关,建议对肝病患者开展血清HDV感染标志物检查,鉴别是否存在HDV重叠感染.