Safety of two-dose schedule of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan) and heterologous additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised and immunocompetent individuals.

Immunocompromised individuals were considered high-risk for severe disease due to SARS COV-2 infection. This study aimed to describe the safety of two doses of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan), followed by additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised (IC) adults, compared to immunocompetent/healthy (H) individuals. This phase 4, multicenter, open label study included solid organ transplant and hematopoietic stem cell transplant recipients, cancer patients and people with inborn errors of immunity with defects in antibody production, rheumatic, end-stage chronic kidney or liver disease, who were enrolled in the IC group.

Effectiveness of CoronaVac in the prevention of COVID-19, a test-negative case-control study in Brazil.

The present study aimed to evaluate the effectiveness of two doses of CoronaVac in preventing SARS-CoV-2 symptomatic disease with virological confirmation, as well as in the prevention of COVID-19 moderate and severe cases. A test-negative unmatched case-control design was used, in which cases were patients with suspected COVID-19 (presenting at least two of the following symptoms: fever, chills, sore throat, headache, cough, runny nose, olfactory or taste disorders) with virological confirmation, and controls were those whose SARS-CoV-2 test was negative. As for exposure, participants were classified as unvaccinated, or vaccinated with a complete schedule.

Efficacy and safety of Butantan-DV in participants aged 2-59 years through an extended follow-up: results from a double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil.

Background: A single-dose dengue vaccine that protects individuals across a wide age range and regardless of dengue serostatus is an unmet need. We assessed the safety and efficacy of the live, attenuated, tetravalent Butantan-dengue vaccine (Butantan-DV) in adults, adolescents, and children. We previously reported the primary and secondary efficacy and safety endpoints in the initial 2 years of follow-up.

Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults.

Background: Butantan-Dengue Vaccine (Butantan-DV) is an investigational, single-dose, live, attenuated, tetravalent vaccine against dengue disease, but data on its overall efficacy are needed.

Methods: In an ongoing phase 3, double-blind trial in Brazil, we randomly assigned participants to receive Butantan-DV or placebo, with stratification according to age (2 to 6 years, 7 to 17 years, and 18 to 59 years); 5 years of follow-up is planned. The objectives of the trial were to evaluate overall vaccine efficacy against symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination (the primary efficacy end point), regardless of serostatus at baseline, and to describe safety up to day 21 (the primary safety end point).

Overview of SARS-COV-2 infection at the Butantan Penitentiary Progression Center.

Objective: To estimate the prevalence of exposure to the SARS-CoV-2 virus among individuals living in restricted freedom.

Methods: A seroprevalence survey was carried out with the population of the female penitentiary of the Centro de Progressão Penitenciária (CPP) in Butantan (municipality of São Paulo), between June 24 and August 20, 2020. During this period, according to the Secretariat of Penitentiary Administration (SAP), the positivity of rapid tests among inmates ranged from 65% to 78%.

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.

Antibody response dynamics to CoronaVac vaccine and booster immunization in adults and the elderly: A long-term, longitudinal prospective study.

Background: The long-term humoral immune response after vaccination varies between vaccines and is dependent on the accuracy of the antibody test. A better understanding of the vaccine immune response may help to define vaccination strategies against coronavirus disease 2019 (COVID-19).

Objective: To investigate the long-term immunological response to CoronaVac vaccine and determinants of breakthrough COVID-19 infection.

Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial.

The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59.

An Open-label Randomized Controlled Parallel-group Pilot Study Comparing the Immunogenicity of a Standard-, Double-, and Booster-dose Regimens of the 2014 Seasonal Trivalent Inactivated Influenza Vaccine in Kidney Transplant Recipients.

Background: Immunogenicity of influenza vaccine in transplant recipients is suboptimal and alternative vaccination regimens are necessary.

Methods: We compared the immunogenicity of a standard-dose trivalent inactivated influenza vaccination (SDTIIV), double-dose trivalent inactivated influenza vaccination (DDTIIV), and booster-dose trivalent inactivated influenza vaccination (BDTIIV) of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipients. We randomized 176 participants to SDTIIV (59), DDTIIV (59), and BDTIIV regimens (58).

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups.

Introduction: Active pharmacovigilance studies are pivotal to better characterize vaccine safety.

Methods: These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns.

COVID-19 in long-term care facilities in Brazil: serological survey in a post-outbreak setting.

This cross-sectional seroepidemiological survey presents the seroprevalence of SARS-CoV-2 in a population living in 15 Long-Term Care Facilities (LTCFs), after two intra-institutional outbreaks of COVID-19 in the city of Botucatu, Sao Paulo State, Brazil. Residents were invited to participate in the serological survey performed in June and July 2020. Sociodemographic and clinical characterization of the participants as well as the LTCF profile were recorded.

Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.

Background: The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV.

Methods: We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil.

Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.

Vaccination has been a successful strategy in influenza prevention. However, despite the safety and efficacy of the vaccines, they can cause adverse events following immunization (AEFI). Moreover, due to the vaccination success, most of vaccine-preventable diseases (VPD) have become rare, and public attention has been shifted from VPD to the AEFI associated with vaccination.

Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan.

Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015.

[Safety profile of heterologous serum produced by the Butantan Institute, in São Paulo-SP, Brazil, from 2012 to 2015].

Objective: to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil.

Methods: a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015.

Results: 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.

Prevalence and titers of yellow fever virus neutralizing antibodies in previously vaccinated adults.

Introduction:: The World Health Organization (WHO) recommends one single dose of the Yellow Fever (YF) vaccine based on studies of antibody persistency in healthy adults. We assessed the prevalence and titers of YF virus neutralizing antibodies in previously vaccinated persons aged  60 years, in comparison to younger adults. We also evaluated the correlation between antibody titers and the time since vaccination among participants who received one vaccine dose, and the seropositivity among participants vaccinated prior to or within the past 10 years.

Public Stigma towards Older Adults with Depression: Findings from the São Paulo-Manaus Elderly in Primary Care Study.

This study investigates three domains of public stigma (perceived negative reactions, perceived discrimination, and dangerousness) against older adults with depression. The sample comprised of older adults registered with primary care clinics (n = 1,291) and primary health care professionals (n = 469) from São Paulo and Manaus, Brazil. Participants read a vignette describing a 70-year-old individual (Mary or John) with a depressive disorder and answered questions measuring stigma.

[Association between chronic pain and self-reported falls in the SABE study population].

The objective of this study was to assess the association between chronic pain and self-reported falls. This was a cross-sectional sample of elderly individuals without cognitive deficits, living in the city of São Paulo, Brazil, and with chronic pain. The study considered elderly that reported chronic pain for at least one year.

Chronic pain and quality of life in schizophrenic patients.

Objective: To identify the prevalence and characteristics of chronic pain in schizophrenic patients and to compare the quality of life in patients with and without chronic pain.

Methods: Crossover design with a probablistic sample of 205 adult schizophrenic outpatients (80% paranoid schizophrenia). Socio-demographic, psychiatric disorder, pain and quality of life (WHOQOL- brief) data were collected between June and September 2008.

Prevalence of fatigue and associated factors in chronic low back pain patients.

Objectives: to determine the prevalence and key factors associated with fatigue in chronic low back pain patients.

Methods: cross-sectional study of 215 chronic low back pain patients from three health care centers and two industrial corporations. The crude prevalence of fatigue and its 95% confidence interval (CI) were calculated.

[Disability related to chronic low back pain: prevalence and associated factors].

Disability related to chronic low back pain (CLBP) is a complex and multidimensional phenomenon. The aim of the study was to identify the prevalence of disability and factors associated with disability outcome in 177 CLBP adults. Respondents were recruited from three health care service centers and answered questions from: Demographic Identification Form, Oswestry Disability Index, Chronic Pain Self-efficacy Scale, Tampa Scale Kinesiophobia, Beck Depression Inventory, and the Revised Piper Fatigue Scale.

[Chronic pain in schizophrenic patients: prevalence and characteristics].

Chronic pain may be at least as prevalent in psychiatric patients as in the general population. To estimate the prevalence of chronic pain in schizophrenic patients, compare the groups with and without chronic pain, and characterize the pain, a cross-sectional study was performed on a probabilistic sample of 205 adult patients with a diagnosis of schizophrenia (mean age 37 years; 65% men; mean schooling nine years; 87% single; 65% living with parents), treated at a public hospital in the city of São Paulo, Brazil. Prevalence of pain was 36.

[Gender differences among persons with HIV admitted to a university reference center in São Paulo, Brazil].

The number of women living with HIV has increased in Brazil, demanding special attention to women's needs. To evaluate gender differences at an HIV reference center in São Paulo, 1,072 patient medical records from 1998 and 2002 were reviewed. As compared to male counterparts, women tended to be younger and have less schooling, and higher proportions of women were married and heterosexual.

TNF gene polymorphisms are associated with reduced survival in severe Chagas' disease cardiomyopathy patients.

Chronic Chagas' disease cardiomyopathy (CCC) is the most important clinical outcome of infection by the parasite Trypanosoma cruzi, affecting 18 million individuals in Latin America. One-third of CCC patients develop heart failure due to end-stage dilated cardiomyopathy, and their survival is reduced by 50% compared to patients with other cardiomyopathies. Genetic susceptibility may play a role in the differential survival of severe CCC patients.

Self-perception of body changes in persons living with HIV/AIDS: prevalence and associated factors.

Background: Highly active antiretroviral therapy has brought about a substantial improvement in the prognosis of HIV/AIDS. In this context, therapy-related body changes (lipodystrophy) gain in importance, in light of the psychological distress they cause and of their association with adherence to treatment. This study analyses patients' self-perception of central fat gain (CFG) and peripheral fat loss (PFL).