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2.
Pediatr Infect Dis J ; 39(2): 164-169, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31929432

RESUMO

BACKGROUND: Hepatitis A is endemic in many countries. Swiss guidelines recommend vaccinating patients native from endemic areas. In Geneva's Children's hospital, migrant children are screened and vaccinated if seronegative. Because hepatitis A's prevalence is decreasing worldwide, more children are seronegative at arrival, highlighting the need for immunization in medical centers and refugee camps and questioning the benefits of systematic serology. Other Swiss hospitals vaccinate regardless of serostatus. This study's aim is to assess migrant children's immunity according to origin and age, and the cost-effectiveness of different immunization strategies. METHODS: We retrospectively analyzed 329 children's serostatus (1-16 years of age) between 2012 and 2015, using enzyme-linked fluorescent assay method. Serology and vaccine costs were based on local prices. Groups were compared with χ test and the age-seropositivity relationship was studied with linear regression. RESULTS: The predominant regions were the Eastern Mediterranean and European Regions with mostly negative serologies (71% and 83%) and the African Region with mostly positive serologies (79%). Immunity varied depending on birth country. Regardless of region, seropositivity increased with age (P < 0.001). The most cost-effective vaccination strategy was an individualized approach based on age and origin, reducing costs by 2% compared with serology-guided immunization and by 17% compared with systematic vaccination. CONCLUSIONS: Many migrant children >5 years old are seronegative and at risk of clinical infection. They need to be immunized. New guidelines according to age and origin should be defined to reduce immunization costs. We recommend systematic vaccination for patients <5 years old or native from low endemicity areas (≤25.7% of seropositivity). For the others, we propose serology-based vaccination.


Assuntos
Vacinas contra Hepatite A/imunologia , Hepatite A/epidemiologia , Hepatite A/prevenção & controle , Migrantes , Vacinação , Adolescente , Criança , Pré-Escolar , Análise Custo-Benefício , Feminino , Hepatite A/transmissão , Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/economia , Humanos , Programas de Imunização , Lactente , Masculino , Programas de Rastreamento , Vigilância em Saúde Pública , Estudos Retrospectivos , Suíça/epidemiologia , Vacinação/economia , Vacinação/métodos
3.
Vaccine ; 37(44): 6648-6655, 2019 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-31548013

RESUMO

INTRODUCTION: Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also pregnant. Limited data are available on the safety of maternal HepA vaccination. OBJECTIVES: Assess the frequency of maternal HepA receipt and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes. METHODS: A retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live births from 2004 through 2015 was included. Pregnancies with HepA exposure were compared to those with other vaccine exposures, and to those with no vaccine exposures. Risk factors for contracting hepatitis A were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were evaluated according to maternal HepA exposure status. Adjusted odds ratio (OR) were used to describe the association. RESULTS: Among 666,233 pregnancies in the study period, HepA was administered at a rate of 1.7 per 1000 (n = 1140), most commonly within the first six weeks of pregnancy. Less than 3% of those exposed to HepA during pregnancy had an ICD-confirmed risk factor. There were no significant associations between HepA exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, and low birthweight. There was a statistically significant association between HepA exposure during pregnancy and small-for-gestational age (SGA) infants (aOR 1.32, [95% CI 1.09, 1.60], p = 0.004). CONCLUSIONS: The rate of maternal HepA vaccination was low and rarely due to documented risk factors for vaccination. HepA vaccination during pregnancy was not associated with an increased risk for a range of adverse events examined among pregnancies resulting in live births, but an identified association between maternal HepA and SGA infant outcomes, while likely due to unmeasured confounding, warrants further exploration.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/efeitos adversos , Vírus da Hepatite A Humana/imunologia , Hepatite A/epidemiologia , Hepatite A/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Adolescente , Adulto , Feminino , Vacinas contra Hepatite A/imunologia , Humanos , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Resultado da Gravidez , Vigilância em Saúde Pública , Estudos Retrospectivos , Vacinação , Adulto Jovem
4.
Vaccine ; 37(16): 2278-2283, 2019 04 10.
Artigo em Inglês | MEDLINE | ID: mdl-30890384

RESUMO

OBJECTIVES: The aim of this study was to evaluate the impact of various factors that may influence the immunologic response to hepatitis A mono-vaccine or hepatitis A/B co-vaccine (Twinrix®) in HIV-infected patients. DESIGN: Retrospective cross-sectional study. METHODS: HIV positive patients with a full course of hepatitis A vaccine were tested for HAV antibodies. The seroconversion rates were determined, and the influence of several factors including CD4 cell counts, CD4/CD8 ratio, plasma viral load, type of vaccine, and antiretroviral therapy at the time of vaccine, was evaluated. RESULTS: After vaccination, 80.2% of the patients developed anti-HAV antibodies, 81.5% in the mono-vaccine group and 79.2% in the hepatitis A/B co-vaccine group. In the mono-vaccine group, factors significantly associated with a better response to the vaccine were higher CD4 cell count, higher CD4/CD8 ratio, and shorter time interval from vaccine to serological control. In patients who received the hepatitis A/B co-vaccine, younger age and female sex were significantly associated with better vaccine response. Multivariable logistic regression analysis revealed time interval from vaccine to serological control of more than 5 years vs. less than 1 year to be significantly associated with decrease of seroconversion after HAV vaccine. CONCLUSIONS: The response to hepatitis A vaccine is impaired in HIV positive patients. HIV patients, at least those older than 30, should be tested for seroconversion after receiving the hepatitis A vaccine. As hepatitis A titers may rapidly decline, control serology during follow-up should be proposed, possibly within two years. However, vaccine type does not play a role in vaccine response.


Assuntos
Coinfecção , Infecções por HIV/imunologia , Vacinas contra Hepatite A/imunologia , Hepatite A/imunologia , Hepatite A/prevenção & controle , Imunidade , Adulto , Idoso , Contagem de Linfócito CD4 , Relação CD4-CD8 , Estudos Transversais , Feminino , Vacinas contra Hepatite A/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Soroconversão , Vacinação , Carga Viral , Adulto Jovem
5.
Am J Infect Control ; 47(8): 883-888, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30879800

RESUMO

BACKGROUND: The hepatitis B (HepB) vaccine is recommended for adults traveling to a country of high or intermediate endemicity. METHODS: Data from the 2016 and 2017 National Health Interview Surveys were pooled. RESULTS: The weighted prevalence of HepB vaccination initiation (≥1 dose) was 37.67% in 2016 (weighted number: 30,581,813/81,192,803) and 40.20% in 2017 (weighted number: 34,509,993/85,849,427). The weighted prevalence of HepB vaccination completion (≥3 doses) was 29.97% in 2016 (weighted number: 24,331,218/81,192,803) and 31.78% in 2017 (weighted number: 27,282,536/ 85,849,427). Characteristics independently associated with HepB vaccination initiation (in descending order by odds ratio) included age, receipt of influenza vaccine, education, ever having lived with someone with hepatitis, class of worker, number of physician visits in the past 12 months, ratio of family income to the poverty threshold, region, sexual orientation, gender, heath insurance, computer use, physical activity, and Hispanic ethnicity. Similar results were found in the analysis for HepB vaccination completion, except that subjects born in the United States showed a higher likelihood of HepB vaccination completion. CONCLUSIONS: HepB vaccination initiation and completion were associated with a number of characteristics that can be utilized to develop strategies to increase HepB vaccination coverage among adults traveling to a country of high or intermediate endemicity.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/imunologia , Hepatite A/prevenção & controle , Viagem , Cobertura Vacinal , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Coleta de Dados , Doenças Endêmicas , Feminino , Saúde Global , Inquéritos Epidemiológicos , Hepatite A/epidemiologia , Humanos , Esquemas de Imunização , Masculino , Pessoa de Meia-Idade , Prevalência , Estados Unidos , Adulto Jovem
6.
Am J Infect Control ; 47(8): 889-894, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30879801

RESUMO

BACKGROUND: Hepatitis A (HepA) vaccine is recommended for adults traveling to a country of high or intermediate endemicity. METHODS: The data from the 2016 and 2017 National Health Interview Survey were pooled in this analysis, and the weighted logistic regression model was adopted. RESULTS: Characteristics independently associated with HepA vaccination initiation (≥1 dose) (in descending order by odds ratio) include age, receipt of pneumococcal and influenza vaccine, education, sexual orientation, region, number of physician visits in the past 12 months, physical activity, marital status, computer use, ratio of family income to the poverty threshold, Hispanic ethnicity, and class of worker. Characteristics independently associated with HepA vaccination completion (≥2 doses) (in descending order by odds ratio) include age, receipt of pneumococcal and influenza vaccine, sexual orientation, education, region, marital status, number of physician visits in the past 12 months, ratio of family income to the poverty threshold, physical activity, Hispanic ethnicity, and computer use. CONCLUSIONS: HepA vaccination initiation and completion was associated with a number of characteristics, which can be used to develop strategies to increase HepA vaccination coverage among adults traveling to a country of high or intermediate endemicity.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/imunologia , Hepatite A/prevenção & controle , Prevalência , Viagem , Cobertura Vacinal , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Coleta de Dados , Doenças Endêmicas , Feminino , Saúde Global , Inquéritos Epidemiológicos , Hepatite A/epidemiologia , Humanos , Esquemas de Imunização , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
7.
Int J Infect Dis ; 82: 129-134, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30862519

RESUMO

OBJECTIVES: The hepatitis A vaccine (HepA) has been included in the national expanded program on immunization (EPI) in China since 2008. This study was performed to evaluate the change in dynamics of the seroepidemiology of hepatitis A virus (HAV) before and after the introduction of the program. METHODS: The trends in seroepidemiology of anti-HAV antibodies were examined in Shandong Province, China, drawing on two population-based samples of persons aged 1-59 years, one obtained in the year 2006 (n = 6682) and the other in 2014 (n = 5095). RESULTS: A dramatic increase in seroprevalence of anti-HAV antibodies from 30.76% (95% confidence interval (CI) 26.24-35.28%) to 77.46% (95% CI 74.04-80.87%) among children aged 1.5-7 years (born after HepA was recommended for routine childhood immunization), as well as an increase from 35.32% (95% CI 29.31-41.33%) to 66.69% (95% CI 55.59-77.80%) in subjects aged 8-14 years, was observed in 2014 when compared with 2006. By contrast, a decline in seroprevalence among subjects aged 15-29 years, as seen particularly in those 20-29 years of age, from 85.72% (95% CI 80.29-91.14%) to 69.24% (95% CI 62.02-76.45%), was found in this study. There was no statistically significant difference in seroprevalence between 2006 and 2014 among the subjects older than 30 years of age. CONCLUSIONS: The national HepA routine immunization program has had a positive effect, leading to an increase in anti-HAV seroprevalence among children in Shandong Province, China. More attention should be paid to young adults in the province.


Assuntos
Anticorpos Anti-Hepatite A/sangue , Vacinas contra Hepatite A/imunologia , Vírus da Hepatite A/imunologia , Hepatite A/epidemiologia , Programas de Imunização , Vacinação , Adolescente , Adulto , Criança , Pré-Escolar , China/epidemiologia , Feminino , Hepatite A/prevenção & controle , Hepatite A/virologia , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Estudos Soroepidemiológicos , Adulto Jovem
8.
Expert Rev Vaccines ; 18(3): 209-223, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30806110

RESUMO

INTRODUCTION: Hepatitis A, caused by hepatitis A virus (HAV), is primarily transmitted via the fecal/oral route either through ingestion of contaminated food and water or through direct contact with an infectious person. Prevalence of hepatitis A is strongly correlated with socioeconomic factors, decreasing with increased socio-economic development, access to clean water and sanitation. Vaccination against HAV should be part of a comprehensive plan for the prevention and control of viral hepatitis, either as part of regular childhood immunization programs or with other recommended vaccines for travelers. Areas covered: We present here evidence for the immunogenicity and safety of an inactivated HAV pediatric vaccine (Avaxim® 80U Pediatric, Sanofi Pasteur), indicated for use in children aged 12 months to 15 years. Data evaluated are from trials undertaken during the clinical development of this vaccine, a systematic literature review and post-market pharmacovigilance. Expert opinion: The pediatric HAV vaccine is highly immunogenic and generates long-lasting protection against hepatitis A disease in children. The safety and immunogenicity data presented in this review suggest that the pediatric HAV vaccine is a valuable option in the prevention of HAV infection in children in many areas of the world where the disease remains a healthcare issue.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Hepatite A/prevenção & controle , Vacinação/métodos , Adolescente , Criança , Pré-Escolar , Vacinas contra Hepatite A/efeitos adversos , Vacinas contra Hepatite A/imunologia , Humanos , Programas de Imunização , Imunogenicidade da Vacina , Lactente , Fatores Socioeconômicos , Vacinas de Produtos Inativados
9.
Medicine (Baltimore) ; 98(6): e14364, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30732169

RESUMO

Several approved inactivated hepatitis A (HA) vaccines are available in Korea. These have been shown to be immunogenic and safe in European children; however, their immunogenicity and safety have not been investigated among Korean children. We aimed to compare the immunogenicity and safety of the most commonly used HA vaccines in ethnic Korean children aged 12 to 18 months.In this open-label, randomized, prospective, multicenter study, 108 children were enrolled and randomized to receive a pediatric form of Avaxim, Epaxal, or Havrix. The 2nd dose was administered after an interval of 6 months. Anti-HA virus (HAV) immunoglobulin (Ig) G was measured to assess geometric mean concentrations (GMCs) and seropositvity rates (≥20 mIU/mL anti-HAV IgG). To assess safety, local solicited adverse events (AEs), systemic solicited AEs, unsolicited AEs, and serious AEs (SAEs) were graded.Among the 108 participants enrolled, 37, 34, and 37 received Avaxim, Epaxal, and Havrix, respectively. After administration of 2 doses, the seropositivity rates in the Avaxim, Epaxal, and Havrix groups were all 100% (95% confidence intervals [CIs]: 99.0-100, 98.9-100, and 99.0-100, respectively; P < .001). The anti-HAV GMCs in the Avaxim, Epaxal, and Havrix groups were 5868.4 (95% CI: 4237.2-8126.6), 1962.1 (95% CI: 1298.0-2965.9), and 2232.9 mIU/mL (95% CI: 1428.4-3490.4), respectively, after administration of 2 doses (P < .001). There were no significant differences in the proportions of participants reporting local solicited AEs, systemic solicited AEs, unsolicited AEs, and SAEs among the 3 vaccine groups after the 1st and 2nd doses. All local solicited and unsolicited AEs were grade 1 or 2. Grade 3 systemic solicited AE occurred in 5.4% and 2.9% of the participants in the Havrix group after the 1st and 2nd doses, respectively. SAEs after the 1st and 2nd doses were reported in 2 participants and 1 participant, respectively, but none was assessed as being related to vaccination.The results indicate that these vaccines were safe and immunogenic in ethnic Korean children. The results have contributed to the establishing of an HA vaccination policy in Korea and will be informative to countries that plan to initiate vaccination programs against HAV.


Assuntos
Vacinas contra Hepatite A/efeitos adversos , Vacinas contra Hepatite A/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Feminino , Vacinas contra Hepatite A/administração & dosagem , Humanos , Lactente , Masculino , Estudos Prospectivos , República da Coreia , Vacinas de Produtos Inativados/administração & dosagem
10.
Pharmeur Bio Sci Notes ; 2019: 11-26, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30714898

RESUMO

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..


Assuntos
Ensaio de Imunoadsorção Enzimática/métodos , Anticorpos Anti-Hepatite A/análise , Vacinas contra Hepatite A/imunologia , Indicadores e Reagentes , Humanos , Indicadores e Reagentes/normas , Colaboração Intersetorial
11.
Pediatr Int ; 61(1): 104-106, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30734430

RESUMO

The aim of this study was to compare the immunogenicity and side-effects of hepatitis A virus (HAV) vaccination between periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) patients and healthy controls who have not been previously exposed to HAV. A prospective observational study was carried out of 28 PFAPA patients and 76 controls who received two doses of the vaccine. Immunogenicity was expressed as seroconversion and seroprotection rates; mean HAV-immunoglobulin G concentration was measured at 0, 1, 7 and 18 months. Side-effects were defined as incidence of adverse events and the effect of vaccination on PFAPA symptoms. All participants were seronegative and seroconverted at 1 month. One month after primary vaccination, 92.9% of PFAPA patients and 77.6% of the controls attained seroprotection, while the rates increased to 100% and 96.1%, respectively, 1 month after the second dose. Seroprotection rates remained adequate 1 year after completion of vaccination. In conclusion, two doses of the inactivated HAV vaccine are well-tolerated and effective in children with PFAPA.


Assuntos
Vacinas contra Hepatite A/efeitos adversos , Doenças Hereditárias Autoinflamatórias/imunologia , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Vacinas contra Hepatite A/imunologia , Humanos , Imunidade Humoral/imunologia , Imunoglobulina G/sangue , Masculino , Estudos Prospectivos
12.
Hepatology ; 70(2): 465-475, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30614542

RESUMO

Serological responses (Seroresponse) and durability of hepatitis A virus (HAV) vaccination are reduced among human immunodeficiency virus (HIV)-positive patients. Incidence of and associated factors with early seroreversion (loss of seroresponse) among HIV-positive patients who have achieved seroresponses after two doses of HAV vaccination remain unclear. In this multicenter study, we followed HIV-positive adults who had mounted seroresponses after completing two doses of HAV vaccination during a recent outbreak of acute hepatitis A between 2015 and 2017, a 1:4 case-control study was conducted to identify factors associated with seroreversion. Case patients were those with seroreversion, and controls were those with similar follow-up durations who were able to maintain seroresponses. During the study period, 49 of the 1,256 patients (3.9%) seroreverted after a median follow-up of 611 days. In a case-control study, seroreversion was more likely to occur in patients with a higher weight (adjusted odds ratio [aOR], 1.703; 95% confidence interval [CI], 1.292-2.323, per 10-kg increment) and HIV viremia at the time of vaccination (aOR, 2.922; 95% CI, 1.067-7.924), whereas positive seroresponse at 6 months of HAV vaccination and higher CD4 lymphocyte counts at vaccination were inversely associated with early seroreversion with an aOR of 0.059 (95% CI, 0.020-0.154) and 0.837 (95% CI, 0.704-0.979, per 100-cell/mm3 increment), respectively, in multivariable analyses. Conclusion: During an outbreak setting, early seroreversion following two-dose HAV vaccination occurred in 3.9% of HIV-positive patients. Lower and delayed seroresponses to HAV vaccination, a higher weight, and HIV viremia and lower CD4 lymphocyte counts at the time of HAV vaccination were associated with early seroreversion. Regular monitoring of seroresponse and booster vaccination might be warranted, especially in HIV-positive adults with predictors of early seroreversion.


Assuntos
Soropositividade para HIV/sangue , Soropositividade para HIV/imunologia , Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/imunologia , Hepatite A/prevenção & controle , Soroconversão , Adulto , Estudos de Casos e Controles , Surtos de Doenças , Feminino , Hepatite A/epidemiologia , Humanos , Masculino , Estudos Retrospectivos , Fatores de Tempo
13.
Pharmeur Bio Sci Notes ; 2019: 1-10, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30648966

RESUMO

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 4th batch of detection antibodies BRRs was established in 2017 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 and HealthCare (EDQM) organised a collaborative study to qualify replacement batches. The candidate BRR antibodies batch 5 were prepared under appropriate conditions from starting materials similar to previous batches to ensure continuity. Prior to the study, a low level of detection was obtained with new batches of the HRPO-GAM provided by the established supplier, supposedly due to a manufacturing issue in the conjugation step. Several other batches procured from the same supplier were tested without any success. Consequently HRPO-GAM batches from 3 other suppliers were tested and one batch was chosen to be included as a BRR based on its suitable characteristics. 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. A higher background OD than in previous batches was observed, so it is recommended to subtract the background from the OD values obtained in the test in order to plot the sigmoid curve and calculate the titre of test samples. Moreover it is recommended that the first dilutions used for the IS and BRP2 should be 1:2 and 1:20, respectively, in order to achieve the same ODmax as for the previous BRRs batches. The BRRs were adopted by correspondence in October 2018 by the Ph. Eur. Commission and are presented as a set containing Hepatitis A virus primary detection antibody BRR batch 5 and Conjugated secondary detection antibody BRR batch 5. They are available from the EDQM as Hepatitis A vaccine ELISA detection antibodies set BRR batch 5.


Assuntos
Anticorpos Anti-Hepatite A/imunologia , Vacinas contra Hepatite A/normas , Anticorpos , Bioensaio , Ensaio de Imunoadsorção Enzimática , Europa (Continente) , Vacinas contra Hepatite A/imunologia , Humanos , Cooperação Internacional , Padrões de Referência , Vacinas de Produtos Inativados
15.
Clin Microbiol Infect ; 25(11): 1422-1427, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30496870

RESUMO

Both live attenuated (HA-L) and inactivated (HA-I) hepatitis A vaccine were licensed for routine use in China. Although phase 1, 2 and 3 clinical studies of both vaccines have been completed, further systematic evaluation of their immunogenicity and immunological persistence under phase 4 clinical studies in a wide range of conditions and involving large populations is necessary. A phase IV clinical trial (NCT02601040) was performed in 9000 participants over 18 months of age. Geometric mean concentrations (GMCs) and seroconversion rates (SRs) were compared at five time points during 3 years for 1800 individuals among them. The SRs of HA-L and HA-I were 98.08% (95% CI 95.59%-99.38%) and 99.64% (95% CI 98.93%-100.00%) respectively 28 days after administration of the first dose, and remained at 97.07% (95% CI 94.31%-98.73%) or above and 96.73% (95% CI 94.07%-98.42%) or above respectively during the following 3 years. The GMCs for both the HA-L and HA-I groups showed that both vaccines elicited high anti-HAV titres, considerably more than the threshold of protection needed against HAV infection in humans, and these titres were sustained. Hence, both HA-I and HA-L vaccines could provide an excellent long-term protective effect, and supported the routine use of both vaccines.


Assuntos
Vacinas contra Hepatite A/imunologia , Vírus da Hepatite A/imunologia , Hepatite A/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , China , Método Duplo-Cego , Feminino , Vacinas contra Hepatite A/administração & dosagem , Anticorpos Anti-Hepatite/sangue , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/imunologia , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
16.
Hum Vaccin Immunother ; 15(2): 426-432, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30431383

RESUMO

Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, PedvaxHIB®, and INFANRIX®) were combined. Among 4,374 participants receiving ≥ 1 dose of HAVi, 4,222 (97%) had safety follow-up and the proportions reporting adverse events (AE) were comparable when administered alone (69.4%) or concomitantly with other pediatric vaccines (71.1%). The most common solicited injection-site AEs were pain/tenderness (Postdose 1: 25.8%; Postdose 2: 26.1%) and redness (Postdose 1: 13.6%; Postdose 2: 15.1%). The most common vaccine-related systemic AEs were fever (≥ 100.4ºF, 12.2%) and irritability (8.1%). Serious AEs (SAEs) were observed at a rate of 0.4%; 0.1% were considered vaccine-related. No deaths were reported within 14 days following a dose of HAVi. These integrated analyses also showed that protective antibody concentrations were elicited in 100% of toddlers after two doses and 92% after a single dose, regardless of whether HAVi was given concomitantly with other vaccines or alone. These results demonstrate that HAVi was well-tolerated whether given alone or concomitantly with other vaccines, with a low incidence of vaccine-related SAEs. HAVi was immunogenic in this age group regardless of whether administered with or without other pediatric vaccines and whether 1 or 2 doses were administered. HAVi did not impact the immune response to other vaccines. These data continue to support the routine use of HAVi with other pediatric vaccines in children ≥ 12 months of age.


Assuntos
Anticorpos Antibacterianos/sangue , Vacinas contra Hepatite A/efeitos adversos , Vacinas contra Hepatite A/imunologia , Imunogenicidade da Vacina , Ensaios Clínicos como Assunto , Feminino , Humanos , Esquemas de Imunização , Lactente , Masculino , Estados Unidos
17.
J Viral Hepat ; 26(1): 199-207, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30315680

RESUMO

Hepatitis A incidence has declined in most countries through a combination of prevention measures, augmented through the use of a highly effective vaccine. In Australia, the proportion of the population susceptible to hepatitis A infection has declined over time due to high rates of opportunistic vaccination as well as the sustained inflow of seropositive immigrants from high-endemicity countries. These factors have contributed to a rapid decline in incidence. An age-structured hepatitis A transmission model incorporating demographic changes was fitted to seroprevalence and disease notification data and used to project incidence trends and transmission potential for hepatitis A in the general population. Robustness of findings was assessed through worst-case scenarios regarding vaccine uptake, migration and the duration of immunity. The decline in age-specific seroprevalence until the introduction of hepatitis A vaccine in 1994 was well explained through a declining basic reproduction number (R0 ) that remained >1. Accounting for existing immunity, we estimated that the effective reproduction number (Reff ) <1 in the general population of Australia since the early 1990s, declining more rapidly after the introduction of the hepatitis A vaccine. Future projections under a variety of scenarios support Reff remaining <1 with continued low incidence in the general population. In conclusion, our results suggest that sustained endemic transmission in the general Australian population is no longer possible although risks of sporadic outbreaks remain. This suggests potential for local elimination of hepatitis A infection in Australia, provided that elimination criteria can be defined and satisfied in risk groups. The methodology used here to investigate elimination potential can easily be replicated in settings such as in the USA where sequential seroprevalence studies are supported by routine notification data.


Assuntos
Notificação de Doenças/estatística & dados numéricos , Hepatite A/epidemiologia , Hepatite A/transmissão , Modelos Teóricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Criança , Pré-Escolar , Erradicação de Doenças/métodos , Erradicação de Doenças/tendências , Surtos de Doenças , Hepatite A/prevenção & controle , Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/imunologia , Humanos , Incidência , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Estudos Soroepidemiológicos , Vacinação/estatística & dados numéricos , Adulto Jovem
18.
Braz. j. infect. dis ; 22(3): 166-170, May-June 2018. tab
Artigo em Inglês | LILACS | ID: biblio-974214

RESUMO

ABSTRACT Vaccination against the hepatitis A virus (HAV) administered in two doses has been used effectively in universal child immunization programs in several countries. A single-dose vaccination was adopted in some low-income countries in an attempt to reduce costs without losing effectiveness. In 2014, single-dose universal vaccination was introduced in Brazil for children aged two years. Since such strategy is still not universally accepted, its efficacy should be compared to the two-dose strategy. To assess the humoral response after the single-dose HAV vaccination schedule, a cross-sectional study was conducted in Primavera do Leste, in Mato Grosso state, Central Brazil, including 265 children vaccinated through the National Immunization Program. Blood was collected by using a digital puncture and further applied to filter paper cards. Anti-HAV was detected in 218 out of 265 dried blood spots (DBS). Blood venous samples were collected from 34 out of 47 children who were not anti-HAV positive in DBS samples. Eighteen of them tested positive for anti-HAV, giving a final score of 93.6% (236/252) of seropositivity. In conclusion, this study demonstrated a high rate of anti-HAV positivity in the short term after single-dose hepatitis A vaccination in the population investigated. Moreover, the DBS was shown to be a reliable tool for detecting anti-HAV antibodies.


Assuntos
Humanos , Masculino , Feminino , Criança , Vacinação em Massa/métodos , Vacinas contra Hepatite A/administração & dosagem , Anticorpos Anti-Hepatite A/sangue , Hepatite A/prevenção & controle , Brasil/epidemiologia , Avaliação de Programas e Projetos de Saúde , Modelos Logísticos , Estudos Soroepidemiológicos , Estudos Retrospectivos , Técnicas Imunoenzimáticas , Esquemas de Imunização , Vírus da Hepatite A Humana/imunologia , Vacinas contra Hepatite A/imunologia , Teste em Amostras de Sangue Seco , Hepatite A/epidemiologia
19.
J Med Virol ; 90(8): 1418-1422, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29663458

RESUMO

In the United States, the incidence of hepatitis A virus (HAV) infection has been reduced through universal childhood vaccination. However, the duration of immunogenicity for the hepatitis A vaccine is not known. We report on the 22 year follow-up time point of a cohort of Alaska children who were randomized to three different vaccine schedules: A) 0, 1, and 2 months; B) 0, 1, and 6 months; and C) 0, 1, and 12 months. Among 46 participant available for follow-up, 40 (87%) maintained protective levels of anti-hepatitis A antibody. These results indicate that a supplemental booster dose is not yet necessary at or before the 22-year time point.


Assuntos
Anticorpos Anti-Hepatite A/sangue , Vacinas contra Hepatite A/administração & dosagem , Vacinas contra Hepatite A/imunologia , Vírus da Hepatite A/imunologia , Adulto , Alaska , Criança , Pré-Escolar , Feminino , Seguimentos , Hepatite A/prevenção & controle , Humanos , Esquemas de Imunização , Masculino , Fatores de Tempo
20.
Braz J Infect Dis ; 22(3): 166-170, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29684320

RESUMO

Vaccination against the hepatitis A virus (HAV) administered in two doses has been used effectively in universal child immunization programs in several countries. A single-dose vaccination was adopted in some low-income countries in an attempt to reduce costs without losing effectiveness. In 2014, single-dose universal vaccination was introduced in Brazil for children aged two years. Since such strategy is still not universally accepted, its efficacy should be compared to the two-dose strategy. To assess the humoral response after the single-dose HAV vaccination schedule, a cross-sectional study was conducted in Primavera do Leste, in Mato Grosso state, Central Brazil, including 265 children vaccinated through the National Immunization Program. Blood was collected by using a digital puncture and further applied to filter paper cards. Anti-HAV was detected in 218 out of 265 dried blood spots (DBS). Blood venous samples were collected from 34 out of 47 children who were not anti-HAV positive in DBS samples. Eighteen of them tested positive for anti-HAV, giving a final score of 93.6% (236/252) of seropositivity. In conclusion, this study demonstrated a high rate of anti-HAV positivity in the short term after single-dose hepatitis A vaccination in the population investigated. Moreover, the DBS was shown to be a reliable tool for detecting anti-HAV antibodies.


Assuntos
Anticorpos Anti-Hepatite A/sangue , Vacinas contra Hepatite A/administração & dosagem , Hepatite A/prevenção & controle , Vacinação em Massa/métodos , Brasil/epidemiologia , Criança , Teste em Amostras de Sangue Seco , Feminino , Hepatite A/epidemiologia , Vacinas contra Hepatite A/imunologia , Vírus da Hepatite A Humana/imunologia , Humanos , Esquemas de Imunização , Técnicas Imunoenzimáticas , Modelos Logísticos , Masculino , Avaliação de Programas e Projetos de Saúde , Estudos Retrospectivos , Estudos Soroepidemiológicos
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