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%. The evaluation method used in the study was the "One Step COVID-19" rapid test (chromatography), from the company Wondfo, also using the RT-PCR method in symptomatic participants to confirm the viral condition. The study population consisted of 879 female inmates and 170 employees of the institution. RESULTS: The prevalence of total antibodies (IgG/IgM) against the SARS-CoV-2 virus in the total population of 1049 study participants was 6.1%; among the population of 879 inmates,a prevalence of 5.8% was observed, and among the institution's employees, 7.5%. CONCLUSIONS: The prevalence of covid-19 at the Butantan CPP was low, which is due to the implementation of simple prevention measures at the institution, such as the use of masks (with appropriate changes), emphasis on hygiene, hand washing and social distancing, in addition to other strategies, such as suspending inmates' visits from relatives and friends and cutting back on elective medical appointments and outside work.

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%. The evaluation method used in the study was the “One Step COVID-19” rapid test (chromatography), from the company Wondfo, also using the RT-PCR method in symptomatic participants to confirm the viral condition. The study population consisted of 879 female inmates and 170 employees of the institution. RESULTS: The prevalence of total antibodies (IgG/IgM) against the SARS-CoV-2 virus in the total population of 1049 study participants was 6.1%; among the population of 879 inmates, a prevalence of 5.8% was observed, and among the institution’s employees, 7.5%. CONCLUSIONS: The prevalence of covid-19 at the Butantan CPP was low, which is due to the implementation of simple prevention measures at the institution, such as the use of masks (with appropriate changes), emphasis on hygiene, hand washing and social distancing, in addition to other strategies, such as suspending inmates’ visits from relatives and friends and cutting back on elective medical appointments and outside work.

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.

Overview of SARS-COV-2 infection at the Butantan Penitentiary Progression Center / Panorama da infecção pelo SARS-COV-2 no Centro de Progressão Penitenciária do Butantan

ABSTRACT 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%. The evaluation method used in the study was the "One Step COVID-19" rapid test (chromatography), from the company Wondfo, also using the RT-PCR method in symptomatic participants to confirm the viral condition. The study population consisted of 879 female inmates and 170 employees of the institution. RESULTS The prevalence of total antibodies (IgG/IgM) against the SARS-CoV-2 virus in the total population of 1049 study participants was 6.1%; among the population of 879 inmates,a prevalence of 5.8% was observed, and among the institution's employees, 7.5%. CONCLUSIONS The prevalence of covid-19 at the Butantan CPP was low, which is due to the implementation of simple prevention measures at the institution, such as the use of masks (with appropriate changes), emphasis on hygiene, hand washing and social distancing, in addition to other strategies, such as suspending inmates' visits from relatives and friends and cutting back on elective medical appointments and outside work.

RESUMO OBJETIVO Estimar a prevalência da exposição ao vírus SARS-CoV-2 entre indivíduos vivendo em restrição de liberdade. MÉTODOS Foi realizado inquérito de soroprevalência com a população da penitenciária feminina do Centro de Progressão Penitenciária (CPP) do Butantan (município de São Paulo), entre 24 de junho e 20 de agosto de 2020. Nesse período, segundo a Secretaria de Administração Penitenciária (SAP), a positividade dos testes rápidos entre detentos variou de 65 a 78%. O método de avaliação utilizado no estudo foi o teste rápido "One Step COVID-19" (cromatografia), da empresa Wondfo, empregando-se também o método RT-PCR em participantes sintomáticos para confirmação do quadro viral. A população do estudo foi constituída por 879 reeducandas e 170 funcionários da instituição. RESULTADOS A prevalência de anticorpos totais (IgG/IgM) contra o vírus SARS-CoV-2 na população total de 1.049 participantes do estudo foi de 6,1%; entre a população de 879 reeducandas foi observada prevalência de 5,8% e entre os servidores da instituição, 7,5%. CONCLUSÃO Houve baixa prevalência de covid-19 no CPP do Butantan, o que se deve à implementação de medidas de prevenção simples na instituição, como o uso de máscaras (com trocas adequadas), ênfase na higiene, lavagem das mãos e distanciamento social, além de outras estratégias, como suspensão de visitas de familiares e amigos das reeducandas, cortes de consultas médicas eletivas e do trabalho externo.

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. Participants were randomly allocated to 8 groups: 1A) IB160 + 15µg H7N9, 1B) IB160 + 7.5µg H7N9, 1C) IB160 + 3.75µg H7N9, 2A) SE + 15µg H7N9, 2B) SE + 7.5µg H7N9, 2C) SE + 3.75µg H7N9, 3) unadjuvanted vaccine 15µg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.

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. Participants were randomly allocated to 8 groups: 1A) IB160 + 15μg H7N9, 1B) IB160 + 7.5μg H7N9, 1C) IB160 + 3.75μg H7N9, 2A) SE + 15μg H7N9, 2B) SE + 7.5μg H7N9, 2C) SE + 3.75μg H7N9, 3) unadjuvanted vaccine 15μg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.

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. Blood samples were collected, processed and serum samples were tested using the rapid One Step COVID-19 immunochromatography test to detect IgM and IgG anti-SARS-CoV-2. Among 209 residents, the median of age was 81 years old, 135 (64.6%) were female and 171 (81.8%) self-referred as being white. An overall seroprevalence of 11.5% (95% CI: 7.5% - 16.6%) was found. The highest seroprevalences of 100% and 76.9% were observed in LTCFs that had experienced COVID-19 outbreaks. Most residents with positive immunochromatography tests (70.8%) referred previous contact with a confirmed COVID-19 case. Although there was a relatively low seroprevalence of COVID-19 in the total number of elderly people, this population is highly vulnerable and LTCFs are environments at higher risk for COVID-19 dissemination. A well-established test for COVID-19 policies, the adequate characterization of the level of interaction between residents and the healthcare provider team and the level of complexity of care are crucial to monitor and control the transmission of SARS-CoV-2 in these institutions.

Caminhos históricos da formação do enfermeiro no campo da saúde mental no Brasil / Historical paths of nursing education in the field of mental health in Brazil / Trayectorias históricas de la educación en enfermería en el campo de la salud mental en Brasil

Objetivos: Este artigo tem como objetivo descrever e refletir sobre as transformações no ensino da enfermagem psiquiátrica e de saúde mental na graduação em enfermagem no Brasil. Método: Trata-se de um estudo descritivo e reflexivo a partir das vivências de estudantes e professores com a área da saúde mental. O recorte temporal estabelecido foi o ano de 1852 até os dias atuais. Resultados: A análise permitiu o agrupamento dos resultados em quatro seções que levaram em consideração os fenômenos históricos determinantes às transformações em cada período ­ 1850 a 1919, 1920 a 1959, 1960 a 1989, 1990 a 2009 e 2010 até os tempos atuais. Discussão: A partir desta análise, é possível apontar transformações significativas no ensino da enfermagem em saúde mental a partir das conquistas sócio-políticas do processo da reforma psiquiátrica brasileira e reformas curriculares, apesar das práticas de ensino nos serviços psicossociais ainda não serem unânimes nos cenários de ensino-aprendizagem dos tempos atuais. Conclusão: No entanto, ratificar avanços históricos é essencial para a manutenção de uma perspectiva de cuidado integral, que resgata a cidadania dos sujeitos através de intervenções criativas, comprometidas e articuladas em rede.

Objectives: This article aims to describe and reflect on the transformations in the teaching of psychiatric nursing and mental health in undergraduate nursing in Brazil. Method: This is a descriptive and reflective study based on the experiences of students and teachers with the area of mental health. The time frame established was the year 1852 to the present day. Results: The analysis allowed the grouping of the results into four sections that took into account the historical phenomena determining the transformations in each period ­ 1850 to 1919, 1920 to 1959, 1960 to 1989, 1990 to 2009 and 2010 to the present times. Discussion: From this analysis, it is possible to point out significant transformations in the teaching of mental health nursing from the socio-political achievements of the Brazilian psychiatric reform process and curricular reforms, although teaching practices in psychosocial services are not yet unanimous in the teaching-learning scenarios of the present times. Conclusion: However, ratifying historical advances is essential for maintaining a perspective of comprehensive care, which rescues the citizenship of the subjects through creative interventions, compromised and articulated in a network.

Objetivos: Este artículo tiene como objetivo describir y reflexionar sobre las transformaciones en la enseñanza de la enfermería psiquiátrica y la salud mental en la enfermería de pregrado en Brasil. Método: Se trata de un estudio descriptivo y reflexivo basado en las experiencias de estudiantes y profesores con el área de salud mental. El marco temporal establecido fue el año 1852 hasta la actualidad. Resultados:El análisis permitió agrupar los resultados en cuatro secciones que tuvieron en cuenta los fenómenos históricos que determinaron las transformaciones en cada período: 1850 a 1919, 1920 a 1959, 1960 a 1989, 1990 a 2009 y 2010 a la actualidad. Discusión: A partir de este análisis es posible señalar transformaciones significativas en la enseñanza de la enfermería en salud mental a partir de los logros sociopolíticos del proceso brasileño de reforma psiquiátrica y las reformas curriculares, aunque las prácticas de enseñanza en los servicios psicosociales aún no son unánimes en los escenarios de enseñanza-aprendizaje de los tiempos actuales. Conclusión: Sin embargo, la ratificación de los avances históricos es esencial para mantener una perspectiva de atención integral, que rescata la ciudadanía de los sujetos a través de intervenciones creativas, comprometidas y articuladas en red.

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

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. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS). Results: A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination. Conclusion: The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

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. Blood samples were collected, processed and serum samples were tested using the rapid One Step COVID-19 immunochromatography test to detect IgM and IgG anti-SARS-CoV-2. Among 209 residents, the median of age was 81 years old, 135 (64.6%) were female and 171 (81.8%) self-referred as being white. An overall seroprevalence of 11.5% (95% CI: 7.5% – 16.6%) was found. The highest seroprevalences of 100% and 76.9% were observed in LTCFs that had experienced COVID-19 outbreaks. Most residents with positive immunochromatography tests (70.8%) referred previous contact with a confirmed COVID-19 case. Although there was a relatively low seroprevalence of COVID-19 in the total number of elderly people, this population is highly vulnerable and LTCFs are environments at higher risk for COVID-19 dissemination. A well-established test for COVID-19 policies, the adequate characterization of the level of interaction between residents and the healthcare provider team and the level of complexity of care are crucial to monitor and control the transmission of SARS-CoV-2 in these institutions.