Immunity to hepatitis A virus in liver transplant recipients: A population-based study in Iran.

BACKGROUND: Acute hepatitis A is usually a self-limited viral disease but can be severe and even fatal in special groups of patients including those with chronic liver disease and recipients of liver transplantation. To take appropriate preventive measures, it is important to determine the immune status against the hepatitis A virus in patients at risk of grave clinical outcomes following infection. To assess the need for immunization against hepatitis A, we aimed to determine the immune status against hepatitis A in a population of liver transplant recipients. We also investigated the association between hepatitis A immune status and demographic factors such as age and sex, underlying liver disease, source of drinking water, geographical area of residence and socioeconomic status. METHODS: This cross-sectional study was performed on 242 recipients of allogenic liver transplants at Abu Ali Sina Organ Transplant Hospital in Shiraz, Iran, between January 2017 and April 2017. The level of immunity was assessed using hepatitis A antibody detection kits. RESULTS: The rate of immunity against hepatitis A was detected as 88.8% in our study population. In the multivariable logistic regression model, younger age (OR=1.175, P<0.001) and higher education level (OR=2.142, P=0.040) were the main determinants of non-immune status. However, hepatitis A immunity was independent of gender, monthly family income, water supply source, residential area and underlying liver disorder. CONCLUSION: Although a significant proportion of liver transplant recipients in this study showed evidence of natural immunity to hepatitis A, a considerable proportion of younger patients and those with a higher level of education were non-immune. The results of this study signify the importance of screening for hepatitis A immunity in this at-risk population of patients and the need for vaccinating non-immune patients.

Detection of Antibodies against Hepatitis A Virus (HAV) by a Surface Plasmon Resonance (SPR) Biosensor: A New Diagnosis Tool Based on the Major HAV Capsid Protein VP1 (SPR-HAVP1).

Hepatitis A (HA) is an acute human infectious disease caused by a positive single-stranded RNA virus (HAV). It is mainly acquired through the fecal-oral route and is primarily spread by contact between people and exposure to contaminated water and food. Recently, large outbreaks of HA have been reported by low and moderate endemicity countries, emphasizing its importance in public health and the need for rapid and large-scale diagnostic tests to support public health decisions on HA. This work proposes a new tool for HAV diagnosis based on the association of surface plasmonic resonance with major capsid protein VP1 (SPR-HAVP1 assay), detecting IgM antibodies for HAV in human serum samples. Structural analyses of VP1 B-lymphocyte epitopes showed continuous and discontinuous epitopes. The discontinuous epitopes were identified in the N-terminal region of the VP1 protein. Both epitope types in the VP1 protein were shown by the reactivity of VP1 in native and denaturing conditions to IgM anti-HAV, which was favorable to tests of VP1 in the SPR assays. SPR-HAVP1 assays showed good performance in the detection of IgM polyclonal antibody anti-HAV. These assays were performed using a COOH5 sensor chip functionalized with VP1 protein. The sensorgram record showed a significant difference between positive and negative serum samples, which was confirmed by analysis of variation of initial and final dissociation values through time (ΔRUd/t). The data gathered here are unequivocal evidence that the SPR-HAVP1 strategy can be applied to detect IgM antibodies in human serum positive to the HAV. This is a new tool to be explored to diagnose human HAV infections.

Antibodies against Hepatitis A and Hepatitis B Virus in Intravenous Immunoglobulin Products.

The worldwide seroprevalence of hepatitis A virus (HAV) and hepatitis B virus (HBV) has changed over the last two decades, indicating a declining incidence of HAV and HBV infections. Therefore, vaccinations against HAV and HBV are recommended for unimmunized people before traveling to an endemic area. Unfortunately, primary antibody deficiency (PAD) patients can only obtain humoral immunity through intravenous immunoglobulin G (IVIG) replacement and not from vaccination because of a defect in antibody production. However, few studies have analyzed the titers of antibodies against HAV or HBV in IVIG products. In this study, the titers of anti-HAV and anti-HBs antibodies were measured in nineteen lots of IVIG products from five manufacturers from three countries (A, B from Korea; C, D from Japan; and E from the USA), and trough titers in plasma were estimated. Concentrations of anti-HAV antibody ranged from 1,888-8,927 mIU/mL and estimated trough titers exceeded the minimal protective value in all evaluated IVIG products. Concentrations of anti-HBs antibody ranged from 438-965 mIU/mL in products A and B and were 157, 123, and 1,945 mIU/mL in products C, D, and E, respectively. Estimated trough titers in products A, B, and E exceeded the minimal protective value but those in products C and D did not reach this threshold. These data demonstrated that available IVIG products generally provide sufficient antibodies against HAV and HBV to protect patients with PAD, although the trough concentrations of anti-HBs antibody in two IVIG products did not reach the minimum protective value.

Response to hepatitis A and B vaccination in pediatric patients with celiac disease.

OBJECTIVES: The aim of the study was to evaluate the response to hepatitis A and B vaccinations in pediatric patients with celiac disease (CD). METHODS: Thirty patients with CD ages 1 to 15 years were compared with 50 healthy age-, sex-, and body mass index-matched controls. Screening for hepatitis A and B serology was carried out before vaccination. Susceptible cases received 20 µg of recombinant DNA vaccine for hepatitis B (0,1, and 6 months) and 720 milliELISA units of inactivated hepatitis A virus (HAV) vaccine (0 and 6 months). Postvaccination serologic evaluation was performed 1 month after the last dose of primary vaccination, 1 month after the booster dose, and once every year during follow-up. RESULTS: Sixteen patients and 35 controls received hepatitis A vaccine; protective anti-HAV antibodies were developed in 12 (75%) of the patients and all of the controls (75% vs 100%, respectively; 95% confidence interval [CI] 0.47-0.92, P=0.007). Thirty patients and 50 controls received hepatitis B vaccine, and 70% of the patients vs 90% of the controls achieved seroprotection (anti-HBs titers ≥10 mIU/mL) 1 month after primary vaccination (95% CI 0.74-0.90, P=0.03). Four patients were unresponsive to both of the vaccines. The overall seroprotection rates were 96% in controls and 80% in patients after the whole hepatitis B vaccination series (95% CI 0.04-0.18, P=0.04). No significant reduction was observed in antibody response among patients and controls during follow-up period. CONCLUSIONS: The rate of seroconversion to the hepatitis B virus- and HAV vaccine is lower in patients with CD than in healthy controls.

Immunogenecity of hepatitis A and B vaccination in pediatric patients with inflammatory bowel disease.

OBJECTIVES: Aim of the study was to evaluate the response to hepatitis A and B vaccination in pediatric patients with inflammatory bowel disease (IBD). METHODS: A total of 47 patients with IBD (25 ulcerative colitis, 14 Crohn's disease, and 8 indeterminate colitis) ages 3 to 17 years were compared with 50 healthy age- and sex-matched controls. Screening for hepatitis A and B serology was carried out before vaccination. Susceptible cases received 20 mg of recombinant DNA vaccine for hepatitis B (0, 1, and 6 months)and 720 milliELISA units of inactivated hepatitis A virus vaccine (HAV) (0 and 6 months). Postvaccination serologic evaluation was performed 1 month after the last dose of primary vaccination, 1 month after the booster dose, and once every year during follow-up. RESULTS: A total of 23 patients and 35 controls received HAV and protective anti-HAV antibodies were developed in all of the patients and controls (P =1.00). Forty-seven patients and 50 controls received hepatitis B vaccine and 70.2% of the patients versus 90% of the controls achieved seroprotection(anti-HBs titers 10 mIU/mL) 1 month after primary vaccination (95% confidence interval 0.71­0.87, P = 0.02). The overall seroprotection rates were 96% in controls and 85.1% in patients after the whole hepatitis B vaccination series (95% confidence interval 0.83­0.95, P = 0.08). No significant reduction was observed in antibody response among patients and controls during the follow-up period. CONCLUSIONS: The rate of seroconversion to the hepatitis B vaccine was lower in pediatric patients with IBD than in healthy controls and hepatitis A vaccine was highly immunogenic among patients with IBD.

Genotyping of acute hepatitis a virus isolates from China, 2003-2008.

Hepatitis A virus (HAV) is usually transmitted by an oral-fecal route and is prevalent not only in developing countries but also in developed countries. In the present study, the phylogenetic characterization of the VP1/2A junction region (321 nucleotides) of China HAV isolates was examined. Anti-HAV IgM-positive serum samples were collected from 8 provinces, including 20 cities or counties in China from 2003 to 2008; 337 isolates from 406 HAV patients' serum samples were amplified by RT-PCR, sequenced at the VP1/2A junction region and aligned with the published sequences from GenBank to establish phylogenetic analysis. All China HAV isolates in this study belonged to genotype I, with 98.8% (333/337) of samples clustering in sub-genotype IA and 1.2% (4/337) in sub-genotype IB. In addition, sub-genotype IA isolates clustered into four groups (92.7-100% nucleotide identity), and the samples collected from all China HAV isolates in this investigation showed 87.5-100% nucleotide identity, but the amino acids in this region were more conserved (95.2-100% identity). Few unique amino acid changes could be deduced (VP1-253: Glu → Gly; 2A-34: Pro → Ala; 2A-33: Leu → Phe). Genetically identical or similar HAV strains existed in some investigated areas in China during different years, suggesting that an indigenous strain has been circulating in those regions. This report provides new data on the genetic relatedness and molecular epidemiology of HAV isolates from China as well as the distribution of sub-genotype IA and IB in this part of the world.

Seroprevalence of hepatitis A virus antibodies in the U.S.: results from the National Health and Nutrition Examination Survey.

OBJECTIVES: We described seroprevalence of antibody to hepatitis A virus (anti-HAV) in the United States during 1999-2006 and compared it with seroprevalence before the availability of vaccine. METHODS: We analyzed data from the 1988-1994 and 1999-2006 National Health and Nutrition Examination Survey (NHANES) to obtain estimates of anti-HAV seroprevalence for the U.S. household population. We grouped region of residence based on the 1999 Advisory Committee on Immunization Practices recommendations into 17 states with any recommendation (vaccinating) and 33 states without any recommendation (non-vaccinating). RESULTS: During 1999-2006, the overall seroprevalence of anti-HAV was 34.9% (95% confidence interval [CI] 33.1, 36.7). During 1999-2006, U.S.-born children living in vaccinating states (33.8%, 95% CI 26.2, 42.2) had a higher seroprevalence than children in non-vaccinating states (11.0%, 95% CI 9.4, 12.8; p < 0.001). Seroprevalence among children increased from 8.0% (95% CI 6.3, 10.1) during 1988-1994 to 20.2% (95% CI 16.0, 24.8) during 1999-2006 (p < 0.001). For U.S.-born children aged 6-19 years, the strongest factor associated with seroprevalence was residence in vaccinating states. Among U.S.-born adults aged > 19 years, the overall age-adjusted seroprevalence of anti-HAV was 29.9% (95% CI 28.3, 31.5) during 1999-2006, which was not significantly different from the seroprevalence during 1988-1994 (32.2%, 95% CI 30.1, 34.4). CONCLUSIONS: Increases in seroprevalence among children in vaccinating states suggest a positive effect of the 1999 vaccination recommendations.

Hepatitis A virus antibodies in immunoglobulin preparations.

BACKGROUND: Persons with primary immune deficiency receive intravenous immunoglobulin (IVIG) as antibody replacement therapy. These patients depend on the presence of protective antibody levels against circulating pathogens in IVIG. OBJECTIVES: The incidence of hepatitis A virus (HAV) infections has been decreasing globally. We investigated whether this decrease in HAV incidence is reflected in human plasma pools and evaluated whether HAV antibody titers in IVIG preparations are still adequate for antibody replacement. METHODS: By using ELISA, the HAV antibody titer of 3,953 plasma pools sourced from March 2003 through September 2008 in the European Union (EU) or United States (US) and of 169 IVIG lots manufactured from 2005 through 2007 was determined. The functionality of the HAV antibodies contained in IVIG was assessed by using a microneutralization assay. RESULTS: The results confirm a decrease in HAV antibody titers in EU (-28%) and US (-41%) plasma. Furthermore, the mean HAV antibody content in EU (1.70 +/- 0.12 IU/mL) and US (0.82 +/- 0.09 IU/mL [mean +/- SEM]) plasma was significantly different (P = .0001). A significant difference (P < .0001) was also evident in the IVIG preparations KIOVIG (22.91 +/- 0.68 IU/mL) and Gammagard Liquid (14.60 +/- 0.48 IU/mL), respectively, made from EU or US plasma. In accordance with the ELISA results, there was a significant difference (P < .0001) in HAV neutralization titer 50% (NT(50)) values between IVIG produced from EU-sourced (2,477 +/- 265 NT(50) [1:X]) or US-sourced (844 +/- 82 NT(50) [1:X]) plasma. CONCLUSION: Although HAV antibody seroprevalence continues to decrease in Europe and the US, HAV antibody titers in IVIG lots appear to remain adequate for antibody replacement therapy.

Nationwide seroprevalence of hepatitis A in South Korea from 2009 to 2019.

Hepatitis A, an acute type of hepatitis caused by the hepatitis A virus, occurs worldwide. Following the 2009 hepatitis A epidemic in South Korea, patient outbreak reports were collectively converted to an "all-patient report" in 2011, and national immunization programs were introduced for children in 2015. In this study, we aimed to analyze the changes and characteristics of hepatitis A antibody titers in South Korea following the epidemic. The results of hepatitis A antibody tests performed at clinical laboratories from 2009 to 2019 were analyzed based on year, age, region, sex, and medical institution. The average 2009-2018 positive anti-hepatitis A virus immunoglobulin G rate was 51.8%, but it increased (56.06%) in 2019. Significantly different antibody-positive rates were observed based on age: <10 years, 54.5%; 20-29 years, 19.5%; ≥50 years, almost 100%. The positive rate of individuals in their teens and 20s gradually increased, whereas that of those in their 30s and 40s gradually decreased. Males had higher antibody-positive rates than females, and samples from higher-level general hospitals exhibited higher antibody rates. The positive anti-hepatitis A virus immunoglobulin M rates gradually decreased after 2009 and were <1% after 2012. However, a high positive rate of 3.69% was observed in 2019 when there was an epidemic. Anti-hepatitis A virus immunoglobulin G-positive rates were similar throughout the year, but the anti-hepatitis A virus immunoglobulin M-positive rates increased from January, peaked in April, and decreased from July, exhibiting distinct seasonality. This is considered to be related to groundwater pollution during the spring drought season. The introduction of the "all-patient report" and national vaccination program for children has had an effective influence on hepatitis A management. However, for hepatitis A prevention, policy considerations for high-risk age groups with low antibody-positive rates will be necessary.

Wastewater workers and hepatitis A virus infection.

BACKGROUND: The main occupational hazard of wastewater workers (WWs) is the direct exposure to the variety of infectious agents present in sewage material, with hepatitis A virus (HAV) being the most frequent one. Most epidemiological studies have shown a higher risk of hepatitis A among WWs, although some studies have produced conflicting evidence. AIMS: To evaluate the hypothesis of increased risk of HAV infection in WWs. METHODS: The prevalence of antibodies to HAV in 869 WWs was compared to 311 other subjects and analysed to detect the main potentially confounding variables. RESULTS: Univariate analysis demonstrated that occupational exposure to sewage was not significantly associated with the prevalence of anti-HAV(+). The anti-HAV(+) prevalence was strongly associated with age and shellfish consumption (P < 0.05) when the subcategories of workers were examined separately (WWs and control group) and jointly. In the logistic regression model, a significant association between anti-HAV(+) prevalence and duration of employment (P < 0.05) was found. The interaction term (age x duration of employment) was significant (P < 0.001) when included in the logistic model. CONCLUSIONS: This study shows that working in a wastewater treatment plant does not seem to be related to a greater prevalence of antibodies to hepatitis A. Moreover, the relative risk of HAV infection among WWs seems to be correlated with low anti-HAV(+) prevalence in the general population.

Immunogenicity and safety of live attenuated hepatitis A vaccine: a multicentric study.

OBJECTIVE: To evaluate immunogenicity and tolerability of single dose live attenuated injectable hepatitis A vaccine in four metropolitan cities of India. METHODS: Live attenuated hepatitis A vaccine was administered to 505 children aged 18 to 60 months in four centers across India. Immunogenicity of the vaccine was assessed by estimation of anti-HAV antibody titer at 6 weeks and 6 months following administration of the vaccine. Safety evaluation of the vaccine was also done during the visits. RESULTS: At 6 weeks, 480 subjects (95%) came for the follow-up and 411 (81.4%) subjects reported at the end of 6 months. The geometric mean titer (GMT) of anti-HAV antibody of the subjects who did not have the seroprotective titer at the baseline were assessed at 6 weeks and 6 months which was 81.04 mIU/ml and 150.66 mIU/ml respectively. At 6 weeks, 95.1 % seroconverted and at the end of 6 months, 97.9 % had seroconverted. Both solicited and unsolicited vaccine-induced local and systemic adverse events were insignificant at all the centers, except swelling and induration in a few. CONCLUSION: Live attenuated injectable hepatitis A vaccine was immunogenic and tolerable with minimal reactogenecity, in this study of single dose schedule. Safety profile was also satisfactory in the study population.

[Epidemiology and clinical features of acute hepatitis A: from the domestic perspective].

Acute viral hepatitis A has recently become a major public health problem in Korea, and the incidence of symptomatic hepatitis A is growing rapidly. With improvements in socioeconomic conditions and environmental hygiene, the chances of exposure to hepatitis A virus (HAV) during childhood have decreased and, in turn, the proportion of young adults with positive anti-HAV has significantly decreased. This has led to the incidence of symptomatic acute hepatitis A increasing since the late 1990s. The incidence of serious complications including fulminant hepatic failure and acute kidney injury has also showed an increasing trend. Variation of the genotype of virus isolated from recent hepatitis A patients suggests an inflow of the hepatitis virus from other countries. In this review article, we present the situation and epidemiology of hepatitis A in Korea, and recommend further investigation and policies for vaccination on a national level.

Establishment of an erythropoietin CRS with stable measurable dimer content for SEC system suitability qualification

The European Pharmacopoeia (Ph. Eur.) monograph 1316 'Erythropoietin concentrated solution' prescribes that the dimer content of therapeutic erythropoietin (EPO) preparations must not exceed 2% as determined by Size-Exclusion Chromatography (SEC). This report describes the evaluation of a candidate Chemical Reference Substance (cCRS) to serve as system suitability reference material for the qualification of SEC systems used to assess dimer and oligomer content in EPO solutions. The study organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) was performed with the participation of six European laboratories which tested the candidate material and the EPO for physicochemical tests CRS batch 1. The candidate material was shown to be a suitable reference material for the determination of the resolving capability of the SEC system for separation of dimer and higher oligomers from monomeric EPO. The cCRS was adopted by the Ph. Eur. Commission as Erythropoietin for SEC system suitability CRS batch 1 following consideration of the report. The importance of the resolving capability of the SEC system, as defined by the peak ratios or the peak-to-valley resolution, together with the asymmetry of the peaks eluted, and the linear response of the UV detector were all seen as critical parameters. Therefore, the monograph Erythropoietin concentrated solution (1316) was revised concomitantly to take account of the CRS and to set acceptance criteria for these critical parameters..

Hepatitis A seroprevalence in Western Cape Province, South Africa: Are we in epidemiological transition?

BACKGROUND: Hepatitis A virus (HAV) is the most common cause of viral hepatitis worldwide. Hepatitis A vaccine is not included in the Expanded Programme on Immunisation in South Africa (EPI-SA), as the country is considered to be highly endemic for hepatitis A. OBJECTIVES: To determine the seroprevalence of hepatitis A infection in Western Cape Province (WCP), South Africa. METHODS: We conducted a cross-sectional seroprevalence study in the 1 - 7-year age group in WCP. Our samples (N=482) were blood specimens left over after laboratory testing obtained from referral hospitals between August and October 2015. A Siemens enzyme immunoassay was used to test for total hepatitis A antibodies. We also analysed hepatitis A immunoglobulin G antibody results from the National Health Laboratory Service (NHLS) Disa*Lab database at Groote Schuur Hospital from 2009 to 2014, and included 2009 - 2014 acute hepatitis A (immunoglobulin M-positive) surveillance data from the National Institute for Communicable Diseases to look at trends in notified acute infections over the same period. RESULTS: Our cross-sectional study showed 44.1% seroprevalence in the 1 - 7-year age group. Hepatitis A data from the NHLS database indicated a seroprevalence of <90% up to age 10 years, indicating intermediate endemicity. The surveillance data showed that a substantial number of symptomatic hepatitis A infections occurred in the 7 - 40-year age group, suggesting that an increasing proportion of the population is susceptible to HAV infection. CONCLUSIONS: These results suggest an urgent need for detailed evidence-based considerations to introduce hepatitis A vaccine into the EPI-SA.

Very low prevalence of anti-HAV in Japan: high potential for future outbreak.

Since the early 21st century, almost all developed countries have had a very low hepatitis A virus antibody (anti-HAV) sero-prevalence profile, as sanitation conditions and health care facilities have been optimized to a universal standard. There has not been a report on anti-HAV prevalence among a large scale population in Japan since 2003. Therefore, this study aimed to investigate the current HAV status among the general population in Hiroshima. From each age and sex specific group, a total of 1,200 samples were randomly selected from 7,682 stocked serum samples from residents' and employees' annual health check-ups during 2013-2015. Total anti-HAV was detected using Chemiluminescent Enzyme Immunoassay. The overall anti-HAV sero-prevalence was 16.8%. In both males and females, anti-HAV prevalence among individuals between 20-59 years of age was as low as 0.0-2.0%, whilst that among 70 s was as high as 70.0-71.0%. A large number of residents aged under 60 are now susceptible to HAV infection. The cohort reduction trend of anti-HAV in Japan exposes the high possibility of mass outbreak in the future. HAV vaccine especially to younger generation and high risk population may prevent outbreak in Japan.

[Acute disseminated encephalomyelitis associated with hepatitis A virus infection]. / Encéphalomyélite aiguë disséminée associée à une infection au virus de l'hépatite virale A chez l'adulte.

INTRODUCTION: Hepatitis virus A (HVA) infection is usually a benign infection, but it can lead to severe manifestations and neurological symptoms. CASE REPORT: We report the case of a 44-year-old man who was admitted for pyramidal tetraparesis, loss of proprioceptive sensitivity and cranial nerve involvement. He had developed concomitally jaundice and fatigue. Brain MRI and cerebrospinal fluid examination were normal. Blood tests revealed elevated serum transaminase and anti-hepatitis A virus (IgM and IgG) levels. Acute disseminated encephalomyelitis (ADEM) was diagnosed and the patient was treated with high dose intravenous then oral corticosteroid therapy. The clinical condition continued to deteriorate and the patient died at eight months. DISCUSSION: ADEM is exceptionally associated with HVA infection or after vaccination for hepatitis A. Other neurological complications, including either peripheral or central nervous system, are reported. The clinical presentation and the outcome of our patient are atypical.

Establishment of detection antibodies BRRs batch 4 for in vitro potency assay of hepatitis A vaccines by ELISA.

The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs). The 3rd batch of detection antibodies BRRs was established in 2015 for use in conjunction with the Ph. Eur. general chapter 2.7.14 'Assay of hepatitis A vaccine'. Stocks of these BRRs were running low and therefore the European Directorate for the Quality of Medicines & HealthCare (EDQM) organised a collaborative study to qualify replacement batches. The candidate BRR antibodies batch 4 were prepared under appropriate conditions from starting materials similar to previous batches to ensure continuity. During the collaborative study, the new batches of antibodies were compared to previous batches of BRRs. Results confirmed that they were suitable to be used for the intended purpose, and could be used at the same final concentrations as the previous batch, i.e. 1:500 for the primary antibody and 1:400 for the conjugated secondary antibody. They were adopted in June 2017 by the Ph. Eur. Commission as Hepatitis A virus primary detection antibody BRR batch 4 and Conjugated secondary detection antibody BRR batch 4, respectively. They are available from the EDQM as Hepatitis A vaccine ELISA detection antibodies set BRR batch 4.

Convenience is the key to hepatitis A and B vaccination uptake among young adult injection drug users.

BACKGROUND: Despite CDC recommendations to vaccinate injection drug users (IDUs) against hepatitis A virus (HAV) and hepatitis B virus (HBV) infections, coverage remains low. Vaccination programs convenient to IDUs have not been widely implemented or evaluated. We assessed whether convenience and monetary incentives influenced uptake of free vaccine by 18-30-year-old IDUs in five U.S. cities. METHODS: IDUs recruited from community settings completed risk behavior self-interviews and testing for antibodies to HAV (anti-HAV) and hepatitis B core antigen (anti-HBc). Vaccine was offered presumptively at pre-test (except in Chicago); on-site availability and incentives for vaccination differed by site, creating a quasi-experimental design. RESULTS: Of 3181 participants, anti-HAV and anti-HBc seroprevalence was 19% and 23%, respectively. Although 83% of participants were willing to be vaccinated, only 36% received > or =1 dose, which varied by site: Baltimore (83%), Seattle (33%), Los Angeles (18%), New York (17%), and Chicago (2%). Participation was highest when vaccine was available immediately on-site and lowest when offered only after receiving results. Monetary incentives may have increased participation when on-site vaccination was not available. CONCLUSION: IDUs were willing to be vaccinated but immediate, on-site availability was critical for uptake. Convenience should be a key consideration in designing strategies to increase vaccine coverage among IDUs.

Dietary plant stanol ester consumption improves immune function in asthma patients: results of a randomized, double-blind clinical trial.

BACKGROUND: In vitro and ex vivo studies have suggested that plant sterols and stanols can shift the T helper (Th) 1/Th2 balance toward a Th1-type immune response, which may be beneficial in Th2-dominant conditions such as asthma and allergies. OBJECTIVE: We evaluated in vivo whether plant stanol esters affect the immune response in asthma patients. DESIGN: Fifty-eight asthma patients participated in a randomized, double-blind, placebo-controlled intervention study. All subjects started with a 2-wk run-in period in which they consumed 150 mL control soy-based yogurt without added plant stanol esters/d. Next, an 8-wk experimental period was started in which one-half of the participants received plant stanol enriched soy-based yogurts (4.0 g plant stanols/d), whereas the other one-half of subjects continued the consumption of control yogurts. After 4 wk of daily plant stanol consumption, all participants were vaccinated against hepatitis A virus (HAV), and the increase of antibody titres was monitored weekly until 4 wk after vaccination. RESULTS: Asthma patients in the plant stanol ester group showed higher antibody titres against HAV 3 and 4 wk after vaccination [19% (P = 0.037) and 22% (P = 0.030), respectively]. Also, substantial reductions in plasma total immunoglobulin E, interleukin (IL)-1ß, and tumor necrosis factor-α were shown in the plant stanol ester group. The increase in serum plant stanol concentrations was correlated significantly with the decrease in IL-13 concentrations and the Th1 switch in the Th1/Th2 balance. However, no absolute differences in cytokine production between the plant stanol ester group and the control group were shown. CONCLUSION: To the best of our knowledge, we are among the first authors to show that plant stanol ester consumption improves the immune function in vivo in asthma patients. This trial was registered at clinicaltrials.gov as NCT01715675.