A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults.

BACKGROUND: To enhance the production and availability of influenza vaccines in different regions of the world is paramount to mitigate the global burden of this disease. Instituto Butantan developed and manufactured an embryonated egg-based inactivated split-virion trivalent seasonal influenza vaccine as part of a technology transfer partnership with Sanofi Pasteur. METHODS: This is a phase IV, randomized, double-blind, active-controlled, multicenter clinical trial including adults 18-60 and > 60 years recruited during the 2019 southern hemisphere influenza season. Subjects were randomized 1:1 to receive either the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine (SP-TIV) or Instituto Butantan Trivalent Seasonal Influenza Vaccine (IB-TIV). Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination. RESULTS: 624 participants were randomized and vaccinated. In both intention-to-treat and per-protocol analysis, non-inferiority of the SP-TIV versus IB-TIV was demonstrated for the three influenza strains. In the per-protocol analysis, the SP-GMT/IB-GMT ratios for H1N1, H3N2, and B were 0.9 (95%CI, 0.7-1.1), 1.2 (95%CI, 1.0-1.4), and 1.1 (95%CI, 0.9-1.3), respectively. Across vaccination groups, the most common adverse reactions (AR) were limited to the injection-site, including pain and tenderness. The majority of the ARs were graded 1 and/or 2 and lasted less than one day. No serious adverse reaction was observed. CONCLUSION: This study demonstrated the non-inferiority of the immunogenicity of a single-dose of Instituto Butantan versus a single dose of the Sanofi Pasteur Seasonal Trivalent Influenza Vaccine in adults. Both vaccines were well tolerated and presented similar safety profiles.

Reducing infection risk in multiple sclerosis and neuromyelitis optica spectrum disorders: a Brazilian reference center's approach.

BACKGROUND: Multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD) are the most common autoimmune diseases of the central nervous system (CNS). They present chronic relapsing courses that demand treatment with disease-modifying drugs (DMDs) to prevent inflammatory activity. Disease-modifying drugs lead to immunomodulation or immunosuppression through diverse mechanisms (e.g., shifting lymphocyte and cytokine profile, suppressing specific lymphocyte subpopulations). Thus, patients are more prone to infectious complications and associated worsening of disease. OBJECTIVE: To present feasible strategies for mitigating the infection risk of MS and NMOSD treated patients. METHODS: Targeted literature review concerning the management of infection risk with an emphasis on vaccination, therapy-specific measures, and particularities of the Brazilian endemic infectious diseases' scenario. CONCLUSION: We propose a vaccination schedule, infectious screening routine, and prophylactic measures based on the current scientific evidence. Awareness of emergent tropical diseases is necessary due to evidence of demyelinating events and possible parainfectious cases of MS and NMOSD.

ANTECEDENTES: A esclerose múltipla (EM) e a doença do espectro neuromielite optica (NMOSD) são as doenças autoimunes mais comuns do sistema nervoso central (SNC). Ambas apresentam curso crônico com recaídas (surtos) e exigem tratamento com drogas modificadoras de doenças (DMDs) para a prevenção de atividade inflamatória. As DMDs levam à imunomodulação ou imunossupressão através de diversos mecanismos (por exemplo deslocando e/ou suprimindo subpopulações linfocitárias ou alterando perfil de produção de citocinas). Desta forma, os pacientes com EM ou NMOSD são mais propensos a complicações infecciosas, as quais podem levar ao agravamento de suas doenças de base. OBJETIVO: Apresentar estratégias viáveis para mitigar o risco de infecção de pacientes com EM ou NMOSD sob tratamento. MéTODOS: Revisão bibliográfica focada em manejo de risco de infecção com ênfase em vacinação, medidas específicas de tratamento e particularidades de doenças infecciosas endêmicas do Brasil. CONCLUSãO: Propomos um calendário de vacinação, rotina de triagem infecciosa e medidas profiláticas baseadas em evidências científicas atuais. A conscientização das doenças tropicais emergentes é necessária devido a evidências de eventos desmielinizantes e possíveis casos parainfecciosos de EM e NMOSD.

Human Papillomavirus (HPV) seroprevalence, cervical HPV prevalence, genotype distribution and cytological lesions in solid organ transplant recipients and immunocompetent women in Sao Paulo, Brazil.

INTRODUCTION: Solid organ transplant (SOT) recipients are at increased risk of Human Papillomavirus (HPV) persistent infection and disease. This study aimed to evaluate HPV seroprevalence, cervical HPV prevalence, genotype distribution, and frequency of HPV-related cervical lesions in SOT recipients in comparison to immunocompetent women. METHODS: Cross-sectional study including SOT and immunocompetent women aged 18 to 45 years who denied previous HPV-related lesions. Cervical samples were screened for HPV-DNA by a polymerase chain reaction (PCR)-based DNA microarray system (PapilloCheck®) and squamous intraepithelial lesions (SIL) by liquid-based cytology. A multiplexed pseudovirion-based serology assay (PsV-Luminex) was used to measure HPV serum antibodies. RESULTS: 125 SOT and 132 immunocompetent women were enrolled. Cervical samples were collected from 113 SOT and 127 immunocompetent women who had initiated sexual activity. HPV-DNA prevalence was higher in SOT than in immunocompetent women (29.6% vs. 20.2%, p = 0.112), but this difference was not statistically significant. High-risk (HR)-HPV was significantly more frequent in SOT than in immunocompetent women (19.4% vs. 7.9%, p = 0.014). Simultaneous infection with ≥2 HR-HPV types was found in 3.1% of SOT and 0.9% of immunocompetent women. HPV seropositivity for at least one HPV type was high in both groups: 63.8% of 105 SOT and 69.7% of 119 immunocompetent women (p = 0.524). Low-grade (LSIL) and high-grade SIL (HSIL) were significantly more frequent in SOT (9.7% and 5.3%, respectively) than in immunocompetent women (1.6% and 0.8%, respectively) (p = 0.001). CONCLUSIONS: These results may reflect the increased risk of HPV persistent infection and disease progression in SOT women due to chronic immunosuppression.

Adverse events following immunization of elderly with COVID-19 inactivated virus vaccine (CoronaVac) in Southeastern Brazil: an active surveillance study.

Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.

Adverse events following yellow fever vaccination in immunocompromised persons.

This observational retrospective study conducted during an yellow fever (YF) outbreak in Sao Paulo, Brazil, in 2017-2018, describes adverse events (AE) following YF vaccination of immunocompromised persons. Risks and benefits of vaccination were individually evaluated by physicians. AE were assessed by phone call or electronic mail, 14 to 90 days after vaccination. Three hundred and eighty one immunocompromised persons received a full-dose of YF vaccine. Their age ranged from 1.4 to 89.3 years (median 50.8 years); 53% were women; 178 (46.7%) had chronic kidney disease, 78 (20.5%) had immune-mediated inflammatory diseases; 94 (24.7%) were using or had recently used immunosuppressive/ immunomodulatory drugs. All of them denied previous YF vaccination. We were able to contact 341 (89.5%) vaccinees: 233 (68.3%) of them received the YF vaccine from BioManguinhos and 108 (31.7%) received the vaccine from Sanofi-Pasteur; 130 (38.1%) vaccinees received other vaccines (up to 4) simultaneously with the the YF vaccine, mostly hepatitis B (59 vaccinees), pneumococcal polysaccharide 23-valent (46), influenza (43) and diphtheria-tetanus (dT, 41). One hundred and eleven vaccinees (32.6%) reported at least one AE: 79 (23.2%) presented systemic AE, 44 (12.9%) had local AE and 12 had both, local and systemic AE. The most common AE was pain at the injection site (41 persons, 12%), myalgia (34; 10%), fever (25; 7.3%) and headache (16; 4.7%). There was no statistically significant difference on the AE frequency according to the vaccine producer. There were four severe AE: one hospitalization and three deaths, considered not related to the YF vaccine.

Common pathogen-associated molecular patterns induce the hyper-activation of NLRP3 inflammasome in circulating B lymphocytes of HIV-infected individuals.

OBJECTIVE: Despite the antiretroviral treatment, people with HIV (PWH) still experience systemic chronic inflammation and immune-senescence, which represent risk factors for severe comorbidities and inefficient response to pathogens and vaccines. Given the dysregulation of NLRP3 inflammasome in PWH and the recently demonstrated role played by NLRP3 in B lymphocytes, we hypothesized that NLRP3 dysregulation in B cells can contribute to chronic inflammation and humoral dysfunction in PWH. DESIGN: NLRP3 inflammasome activation was evaluated in B lymphocytes and correlated with antibodies production and immunization response in PWH. METHODS: NLRP3 inflammasome activation was compared in B lymphocytes isolated from PWH and healthy donors, in resting and stimulated conditions. Functional polymorphic variants in NLRP3 and IL1B genes were analysed in a cohort of PWH submitted to anti-HBV vaccine to assess the effect of NLRP3 inflammasome on humoral response. RESULTS: The NLRP3 inflammasome activation in response to common PAMPs (LPS, ß-glucan) resulted higher in B lymphocytes of PWH than in HD. CpG-induced IgM secretion was also increased in B cells of PWH. NLRP3, but not IL1B, gain-of-function polymorphism associated to anti-HBs levels. CONCLUSION: These data reveal the dysregulation of NLRP3 inflammasome in B lymphocytes of PWH. Differently from myeloid compartment, which present an exhausted NLRP3 inflammasome, the complex appears to be hyper-activated in B cells of PWH, likely contributing to chronic inflammation and affecting humoral response.

Use of infrared thermography in a case of systemic envenomation by the coral snake Micrurus frontalis (Duméril et al., 1854) in Sao Paulo, Brazil.

Infrared thermography is a technique that quantifies the thermal (infrared) radiation emitted by an object and produces a high-resolution, digital thermal image of it. Medically, this technique is used to visualize the body's surface temperature distribution in a non-invasive, safe, and convenient fashion. However, to the best of our knowledge, the use of infrared thermography for assessing the systemic effects of envenomation by coral snakes has not been reported. In this case report, we describe the use of this technique in the management of a case of snakebite in Sao Paulo, Brazil. A 51-year-old woman was bitten on the back of the right hand by Micrurus frontalis, a species of coral snake, 10 min prior to her arrival at the hospital. Infrared imaging performed at admission revealed elevated temperatures at the bite site and in the elbow, as well as the preservation of a normal distal thermal gradient in both hands. A few minutes later, the patient developed muscle weakness in the upper limbs and in the eyelids, and infrared imaging showed an alteration of the thermal gradient in both hands, reflecting the systemic action of the venom. Following these observations, the patient was treated with the specific antivenom and was discharged 48 h post admission. At the two-week follow-up, the thermal image obtained showed no anomalies, indicating the recovery of the patient. Hence, infrared thermography can be very useful in the early identification of systemic neurotoxicity in cases of Micrurus snake bites, facilitating the decision to prescribe the antivenom.

Low tetanus-diphtheria-acellular pertussis (Tdap) vaccine coverage among healthcare workers in a quaternary university hospital in São Paulo, Brazil: need for continuous surveillance and implementation of active strategies.

INTRODUCTION: Vaccination with tetanus-diphtheria-acellular pertussis (Tdap) has been recommended for healthcare workers (HCWs) by Brazilian Ministry of Health since November 2014. OBJECTIVE: To describe the strategies implemented to improve Tdap uptake, cumulative vaccine coverage after each intervention, variables associated to Tdap vaccination, and reasons for non-vaccination among HCWs of the main building of a quaternary hospital attached to the Sao Paulo University Medical School. METHODS: A list of HCWs eligible for pertussis vaccination was generated. From April to December 2015, the following interventions were implemented: note on intern journal reminding the importance of pertussis vaccination; email to the head nurses strengthening vaccine recommendations; lectures on pertussis and Tdap for physicians of Obstetrics and Neonatology Clinics; on-site vaccination by mobile teams at the Obstetrics, Neonatology, and Anesthesiology Clinics. Vaccine coverage was accessed at the end of each month. Multivariate Poisson regression model with a robust error variance was used to evaluate variables associated with Tdap vaccination. Reasons for non-vaccination were evaluated from January to May 2017 through phone calls for HCWs who had not received Tdap. RESULTS: The study included 456 HCWs. After the interventions, Tdap coverage raised from 2.8% to 41.2%. In the multivariate analysis, occupation (physician), working place (obstetrics or anesthesiology) and influenza vaccination in 2015 were independently associated to Tdap vaccination. The main reason for non-vaccination was unawareness of Tdap recommendations. CONCLUSIONS: Tdap uptake among HCWs was low in our hospital. Providing vaccination at convenient places/times for HCW seems to be the most efficient strategy to increase vaccine uptake.

Long-term protection after hepatitis B vaccination in people living with HIV.

BACKGROUND: Hepatitis B vaccine is important in people living with HIV (PLHIV) since both viruses have the same transmission routes and co-infection has greater morbidity. PLHIV usually have poor response to hepatitis B vaccine. The duration of immunity in PLHIV is unknown. The objective of this study is to evaluate the duration of serological response and clinical protection provided by hepatitis B vaccination in PLHIV. METHODS: Retrospective study of a PLHIV cohort primarily vaccinated for hepatitis B virus (HBV) from 2001 to 2002. Markers of infection and protection from HBV were investigated in those individuals who were still attending the outpatient clinic, in São Paulo, Brazil from 2012 to 2014. Three groups were analyzed. Group 1: adults who responded to primary vaccine series. Group 2: non-responders to primary vaccine series. Group 3: subjects from both Groups 1 and 2 who did not receive any booster doses after seroconversion. RESULTS: A cohort of 121 PLHIV was analyzed for seroconversion and persistence of anti-HBs. The majority were female (54.5%) and mean age was 50.1years. After 11years, none of the patients had serologic evidence of HBV infection. Overall, 41/58 (70.7%) of the initial responders (Group 1) had maintained anti-HBs≥10mIU/mL. Greater CD4+ values and anti-HBs>100mIU/mL at the time of first vaccine series were associated with persistence of anti-HBs. During the time of evaluation, 35/63 (55.6%) of the initial non-responders (Group 2) successfully seroconverted (anti-HBs≥10mIU/mL) in response to one or more booster doses. From the time of their seroconversion, 70 of the patients did not receive any further booster doses (Group 3). After 10years, 54/70 (77.1%) of these individuals has maintained anti-HBs≥10mIU/mL. CONCLUSIONS: Evaluation of long-term immunity for hepatitis B in PLHIV following vaccination showed a strong persistence of anti-HBs and no serologic evidence of HBV infection. Boosters may be effective in PLHIV non-responders to primary vaccination.

Reducing infection risk in multiple sclerosis and neuromyelitis optica spectrum disorders: a Brazilian reference center's approach / Redução do risco de infeção em esclerose múltipla e doença do espectro neuromielite óptica: abordagem de um centro de referência brasileiro

Abstract Background Multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD) are the most common autoimmune diseases of the central nervous system (CNS). They present chronic relapsing courses that demand treatment with disease-modifying drugs (DMDs) to prevent inflammatory activity. Disease-modifying drugs lead to immunomodulation or immunosuppression through diverse mechanisms (e.g., shifting lymphocyte and cytokine profile, suppressing specific lymphocyte subpopulations). Thus, patients are more prone to infectious complications and associated worsening of disease. Objective To present feasible strategies for mitigating the infection risk of MS and NMOSD treated patients. Methods Targeted literature review concerning the management of infection risk with an emphasis on vaccination, therapy-specific measures, and particularities of the Brazilian endemic infectious diseases' scenario. Conclusion We propose a vaccination schedule, infectious screening routine, and prophylactic measures based on the current scientific evidence. Awareness of emergent tropical diseases is necessary due to evidence of demyelinating events and possible parainfectious cases of MS and NMOSD.

Resumo Antecedentes A esclerose múltipla (EM) e a doença do espectro neuromielite optica (NMOSD) são as doenças autoimunes mais comuns do sistema nervoso central (SNC). Ambas apresentam curso crônico com recaídas (surtos) e exigem tratamento com drogas modificadoras de doenças (DMDs) para a prevenção de atividade inflamatória. As DMDs levam à imunomodulação ou imunossupressão através de diversos mecanismos (por exemplo deslocando e/ou suprimindo subpopulações linfocitárias ou alterando perfil de produção de citocinas). Desta forma, os pacientes com EM ou NMOSD são mais propensos a complicações infecciosas, as quais podem levar ao agravamento de suas doenças de base. Objetivo Apresentar estratégias viáveis para mitigar o risco de infecção de pacientes com EM ou NMOSD sob tratamento. Métodos Revisão bibliográfica focada em manejo de risco de infecção com ênfase em vacinação, medidas específicas de tratamento e particularidades de doenças infecciosas endêmicas do Brasil. Conclusão Propomos um calendário de vacinação, rotina de triagem infecciosa e medidas profiláticas baseadas em evidências científicas atuais. A conscientização das doenças tropicais emergentes é necessária devido a evidências de eventos desmielinizantes e possíveis casos parainfecciosos de EM e NMOSD.

Adverse events following immunization of elderly with COVID-19 inactivated virus vaccine (CoronaVac) in Southeastern Brazil: an active surveillance study

ABSTRACT Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.

Healthcare resource utilization and costs of outpatient follow-up after liver transplantation in a university hospital in São Paulo, Brazil: cost description study.

CONTEXT AND OBJECTIVE: Data on the costs of outpatient follow-up after liver transplantation are scarce in Brazil. The purpose of the present study was to estimate the direct medical costs of the outpatient follow-up after liver transplantation, from the first outpatient visit after transplantation to five years after transplantation. DESIGN AND SETTING: Cost description study conducted in a university hospital in São Paulo, Brazil. METHODS: Cost data were available for 20 adults who underwent liver transplantation due to acute liver failure (ALF) from 2005 to 2009. The data were retrospectively retrieved from medical records and the hospital accounting information system from December 2010 to January 2011. RESULTS: Mean cost per patient/year was R$ 13,569 (US$ 5,824). The first year of follow-up was the most expensive (R$ 32,546 or US$ 13,968), and medication was the main driver of total costs, accounting for 85% of the total costs over the five-year period and 71.9% of the first-year total costs. In the second year after transplantation, the mean total costs were about half of the amount of the first-year costs (R$ 15,165 or US$ 6,509). Medication was the largest contributor to the costs followed by hospitalization, over the five-year period. In the fourth year, the costs of diagnostic tests exceeded the hospitalization costs. CONCLUSION: This analysis provides significant insight into the costs of outpatient follow-up after liver transplantation due to ALF and the participation of each cost component in the Brazilian setting.

Low tetanus-diphtheria-acellular pertussis (Tdap) vaccine coverage among healthcare workers in a quaternary university hospital in São Paulo, Brazil: need for continuous surveillance and implementation of active strategies

Abstract Introduction: Vaccination with tetanus-diphtheria-acellular pertussis (Tdap) has been recommended for healthcare workers (HCWs) by Brazilian Ministry of Health since November 2014. Objective: To describe the strategies implemented to improve Tdap uptake, cumulative vaccine coverage after each intervention, variables associated to Tdap vaccination, and reasons for non-vaccination among HCWs of the main building of a quaternary hospital attached to the Sao Paulo University Medical School. Methods: A list of HCWs eligible for pertussis vaccination was generated. From April to December 2015, the following interventions were implemented: note on intern journal reminding the importance of pertussis vaccination; email to the head nurses strengthening vaccine recommendations; lectures on pertussis and Tdap for physicians of Obstetrics and Neonatology Clinics; on-site vaccination by mobile teams at the Obstetrics, Neonatology, and Anesthesiology Clinics. Vaccine coverage was accessed at the end of each month. Multivariate Poisson regression model with a robust error variance was used to evaluate variables associated with Tdap vaccination. Reasons for non-vaccination were evaluated from January to May 2017 through phone calls for HCWs who had not received Tdap. Results: The study included 456 HCWs. After the interventions, Tdap coverage raised from 2.8% to 41.2%. In the multivariate analysis, occupation (physician), working place (obstetrics or anesthesiology) and influenza vaccination in 2015 were independently associated to Tdap vaccination. The main reason for non-vaccination was unawareness of Tdap recommendations. Conclusions: Tdap uptake among HCWs was low in our hospital. Providing vaccination at convenient places/times for HCW seems to be the most efficient strategy to increase vaccine uptake.

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of São Paulo, Brazil.

INTRODUCTION: This paper describes adverse events (AEs) temporally associated to the pandemic influenza A (H1N1) vaccine observed in a reference center in São Paulo, Brazil, during a 2010 mass vaccination campaign. METHODS: A retrospective study involving persons who sought medical care for AEs following influenza vaccination. Data were retrieved from medical records, vaccine AE notification forms, and a computerized system for immunobiological registration. RESULTS: Sixty-six vaccinees sought medical care for AEs after immunization. The most frequent AEs were fever, headache, myalgia, and pain at the injection site. No serious AEs were reported. CONCLUSIONS: Few vaccinees spontaneously reported AEs to influenza A (H1N1) vaccine at this center.

Active assessment of adverse events following yellow fever vaccination of persons aged 60 years and more.

INTRODUCTION: Older age has been associated to serious adverse events (AE) following yellow fever (YF) vaccination in passive surveillance studies, but few prospective studies involving seniors have been published. RESULTS: A total of 906 persons were evaluated; 78 were not vaccinated and 828 received the vaccine; 700 (84.7%) were interviewed after vaccination: 593 (84.7%) did not report any symptoms or signs following YF vaccine; 107 (15.3%) reported at least one AE temporally associated to YF vaccination: 97 (13.9%) had systemic AE and 17 (2.4%) reported AE at the injection site (7 had both systemic and local AE). Data regarding previous vaccination was available for 655 subjects. Statistically significant higher rates of systemic AE were observed among subjects who received the first YF vaccination (17.5%) in comparison to persons who had been previously vaccinated (9.5%). METHODS: This observational prospective study aimed to describe AE following YF vaccination in persons aged ≥ 60 y. From March 2009 to April 2010, seniors who sought YF vaccination at a reference Immunization Center in São Paulo city, Brazil, were included. Demographic and clinical data, previous YF vaccination, travel destination and the final decision regarding YF vaccination or not were collected from standardized medical records. Active AE assessment was done through telephone or electronic mail interview performed approximately 14 d after immunization. CONCLUSION: Most persons aged ≥ 60 y may be safely vaccinated against YF. Before vaccination, they must be carefully screened for conditions associated to altered immunocompetence and for risk of exposure to YF.

Healthcare resource utilization and costs of outpatient follow-up after liver transplantation in a university hospital in São Paulo, Brazil: cost description study / Utilização de recursos em saúde e custos do acompanhamento ambulatorial pós-transplante de fígado em um hospital universitário em São Paulo, Brasil: estudo de descrição de custos

CONTEXT AND OBJECTIVE: Data on the costs of outpatient follow-up after liver transplantation are scarce in Brazil. The purpose of the present study was to estimate the direct medical costs of the outpatient follow-up after liver transplantation, from the first outpatient visit after transplantation to five years after transplantation. DESIGN AND SETTING: Cost description study conducted in a university hospital in São Paulo, Brazil. METHODS: Cost data were available for 20 adults who underwent liver transplantation due to acute liver failure (ALF) from 2005 to 2009. The data were retrospectively retrieved from medical records and the hospital accounting information system from December 2010 to January 2011. RESULTS: Mean cost per patient/year was R$ 13,569 (US$ 5,824). The first year of follow-up was the most expensive (R$ 32,546 or US$ 13,968), and medication was the main driver of total costs, accounting for 85% of the total costs over the five-year period and 71.9% of the first-year total costs. In the second year after transplantation, the mean total costs were about half of the amount of the first-year costs (R$ 15,165 or US$ 6,509). Medication was the largest contributor to the costs followed by hospitalization, over the five-year period. In the fourth year, the costs of diagnostic tests exceeded the hospitalization costs. CONCLUSION: This analysis provides significant insight into the costs of outpatient follow-up after liver transplantation due to ALF and the participation of each cost component in the Brazilian setting. .

CONTEXTO E OBJETIVO: Dados sobre os custos do seguimento ambulatorial pós-transplante de fígado são escassos no Brasil. O objetivo do presente estudo foi estimar os custos diretos médicos do seguimento ambulatorial pós-transplante de fígado a partir da primeira visita ambulatorial pós-transplante até cinco anos após o transplante. TIPO DE ESTUDO E LOCAL: Estudo de descrição de custos realizado em um hospital universitário em São Paulo, Brasil. MÉTODOS: Dados de custos estavam disponíveis para 20 adultos que foram submetidos a transplante de fígado devido a insuficiência hepática aguda (IHA) de 2005 a 2009. Os dados foram retrospectivamente obtidos em prontuários médicos e no sistema de informação contábil hospitalar de dezembro de 2010 a janeiro de 2011. RESULTADOS: A média de custo por paciente/ano foi de R$ 13.569 (US$ 5.824). O primeiro ano de acompanhamento foi o mais caro, R$ 32.546 (US$ 13,968), e medicação foi o principal impulsionador dos custos totais, respondendo por 85% dos custos totais no período de cinco anos e 71,9% dos custos totais do primeiro ano. No segundo ano pós-transplante, os custos médios totais foram cerca da metade do montante de custos do primeiro ano (R$ 15.165 ou US$ 6,509). Medicação foi o maior contribuinte para os custos seguido da internação, no período de cinco anos. No quarto ano, os custos dos testes diagnósticos superam os custos de internação. CONCLUSÃO: Esta análise proporciona uma compreensão significativa dos custos do seguimento ambulatorial pós-transplante de fígado por IHA e a participação de cada componente de custo no cenário brasileiro. .

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of Sao Paulo, Brazil

Introduction This paper describes adverse events (AEs) temporally associated to the pandemic influenza A (H1N1) vaccine observed in a reference center in São Paulo, Brazil, during a 2010 mass vaccination campaign. Methods A retrospective study involving persons who sought medical care for AEs following influenza vaccination. Data were retrieved from medical records, vaccine AE notification forms, and a computerized system for immunobiological registration. Results Sixty-six vaccinees sought medical care for AEs after immunization. The most frequent AEs were fever, headache, myalgia, and pain at the injection site. No serious AEs were reported. Conclusions Few vaccinees spontaneously reported AEs to influenza A (H1N1) vaccine at this center. .