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1.
Epidemiol Serv Saude ; 33: e2023899, 2024.
Article in English, Portuguese | MEDLINE | ID: mdl-38629675

ABSTRACT

OBJECTIVE: To describe the profile of cases of mpox in the city of Rio de Janeiro between June and November 2022. METHODS: This was a descriptive study of secondary data obtained from mpox notification forms. Socioeconomic, clinical and spatial data were analyzed. RESULTS: Of the 928 cases, 93.7% were male, 85.0% cisgender male, 65.6% homosexual, 41.8% between 30 and 39 years old, and 41.0% were of White race/skin color. A total of 34.5% had immunosuppression due to illness, and 41.9% reported their HIV status as being positive. The most prevalent signs and symptoms were: skin lesions (96.6%), especially with multiple manifestations (67.8%) in the genital region (46.1%), in addition to fever (58.3%), adenomegaly (43.3%) and headache (38.7%). Most notifications occurred in public services (81.3%) and in hospital care (51.3%). CONCLUSION: The study revealed high incidence of mpox, especially among young, cisgender and homosexual men. Most cases were mild, with genital lesions, progressing to cure without hospitalization. Person-to-person transmission was predominant.


Subject(s)
Mpox (monkeypox) , Humans , Male , Adult , Female , Brazil/epidemiology , Cities , Incidence , Socioeconomic Factors
2.
NPJ Vaccines ; 9(1): 7, 2024 Jan 05.
Article in English | MEDLINE | ID: mdl-38182593

ABSTRACT

With the continued emergence of variants of concern, the global threat of COVID-19 persists, particularly in low- and middle-income countries with limited vaccine access. Protein-based vaccines, such as SCB-2019, can be produced on a large scale at a low cost while antigen design and adjuvant use can modulate efficacy and safety. While effective humoral immunity against SARS-CoV-2 variants has been shown to depend on both neutralization and Fc-mediated immunity, data on the effectiveness of protein-based vaccines with enhanced Fc-mediated immunity is limited. Here, we assess the humoral profile, including antibody isotypes, subclasses, and Fc receptor binding generated by a boosting with a recombinant trimer-tag protein vaccine SCB-2019. Individuals who were primed with 2 doses of the ChAdOx1 vaccine were equally divided into 4 groups and boosted with following formulations: Group 1: 9 µg SCB-2019 and Alhydrogel; Group 2: 9 µg SCB-2019, CpG 1018, and Alhydrogel; Group 3: 30 µg SCB-2019, CpG 1018, and Alhydrogel; Group 4: ChAdOx1. Group 3 showed enhanced antibody FcγR binding against wild-type and variants compared to Groups 1 and 2, showing a dose-dependent enhancement of immunity conferred by the SCB-2019 vaccine. Moreover, from day 15 after vaccination, Group 3 exhibited higher IgG3 and FcγR binding across variants of concerns, including Omicron and its subvariants, compared to the ChAdOx1-boosted individuals. Overall, this highlights the potential of SCB-2019 as a cost-efficient boosting regimen effective across variants of concerns.

3.
J Crit Care ; 79: 154451, 2024 02.
Article in English | MEDLINE | ID: mdl-37871403

ABSTRACT

PURPOSE: The goal of this study was to investigate severe central nervous system infections (CNSI) in adults admitted to the intensive care unit (ICU). We analyzed the clinical presentation, causes, and outcomes of these infections, while also identifying factors linked to higher in-hospital mortality rates. MATERIALS AND METHODS: We conducted a retrospective multicenter study in Rio de Janeiro, Brazil, from 2012 to 2019. Using a prediction tool, we selected ICU patients suspected of having CNSI and reviewed their medical records. Multivariate analyses identified variables associated with in-hospital mortality. RESULTS: In a cohort of 451 CNSI patients, 69 (15.3%) died after a median 11-day hospitalization (5-25 IQR). The distribution of cases was as follows: 29 (6.4%) had brain abscess, 161 (35.7%) had encephalitis, and 261 (57.8%) had meningitis. Characteristics: median age 41 years (27-53 IQR), 260 (58%) male, and 77 (17%) HIV positive. The independent mortality predictors for encephalitis were AIDS (OR = 4.3, p = 0.01), ECOG functional capacity limitation (OR = 4.0, p < 0.01), ICU admission from ward (OR = 4.0, p < 0.01), mechanical ventilation ≥10 days (OR = 6.1, p = 0.04), SAPS 3 ≥ 55 points (OR = 3.2, p = 0.02). Meningitis: Age > 60 years (OR = 234.2, p = 0.04), delay >3 days for treatment (OR = 2.9, p = 0.04), mechanical ventilation ≥10 days (OR = 254.3, p = 0.04), SOFA >3 points (OR = 2.7, p = 0.03). Brain abscess: No associated factors found in multivariate regression. CONCLUSIONS: Patients' overall health, prompt treatment, infection severity, and prolonged respiratory support in the ICU all significantly affect in-hospital mortality rates. Additionally, the implementation of CNSI surveillance with the used prediction tool could enhance public health policies.


Subject(s)
Brain Abscess , Central Nervous System Infections , Encephalitis , Meningitis , Adult , Humans , Male , Middle Aged , Female , Retrospective Studies , Brazil/epidemiology , Critical Care , Intensive Care Units , Hospital Mortality , Central Nervous System Infections/epidemiology , Meningitis/epidemiology
4.
J Allergy Clin Immunol Glob ; 2(3): 100101, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37779527

ABSTRACT

Background: Vaccination is an extremely safe public health intervention, but rare IgE-mediated adverse events must be identified to avoid the risk of anaphylaxis in the event of reexposure. However, using only clinical history to diagnose previous allergic reactions may lead to overdiagnosis of vaccine allergy and even to the use of medical exemptions as a subterfuge to mandatory vaccination. Methods: We conducted a retrospective study to describe the outcomes of patients with a history of vaccine or vaccine component allergy who were evaluated at our unit from 2011 to 2017. Data on allergy history, skin test results, vaccines prescribed, and adverse events were retrieved from the medical records at the Centro de Referência para Imunobiológicos Especiais (Reference Center of Special Immunobiologicals)-Fiocruz, in Rio de Janeiro, Brazil. Results: Of 34 adults with history of allergy to vaccine or vaccine components, 32 (94.1%) were successfully vaccinated without serious adverse events after our evaluation. In 12 patients (35%), the time elapsed between the allergy symptoms and evaluation in the Centro de Referência para Imunobiológicos Especiais-Fiocruz was more than 10 years. Conclusion: Specialized care and use of skin tests allowed safe vaccination of the majority of patients. An objective, systematic evaluation of a history of vaccine allergy can prevent its improper use to avoid mandatory vaccination and reduce missed opportunities for immunization.

5.
Cad Saude Publica ; 39(2): e00075522, 2023.
Article in English | MEDLINE | ID: mdl-36946796

ABSTRACT

The objectives were to estimate hepatitis A virus seroprevalence in subjects attending to a travel medicine and immunization clinic in Rio de Janeiro, Brazil, and to develop a prediction model for hepatitis A virus seroprevalence. This retrospective research included individuals sequentially from April 2011 to June 2019 at a travel medicine and special population immunization clinic with an anti-hepatitis A virus IgG chemiluminescence result. Participants' data were verified via electronic medical records. Data were split into development and validation set taking 2018 as the date break. A cross-validated elastic generalized linear model with binomial distribution was performed. In total, 2,944 subjects were analyzed. Hepatitis A virus overall seroprevalence was 67.8%. Health professionals, travelers, and those who had contact with immunocompromised subjects had lower seroprevalence (40%-55%), whereas subjects with chronic conditions (heart, lung, and liver) ranged from 89% to 94%. The retained predictors in the final model were sex, age, year of birth, travelers, HIV/AIDS, spleen dysfunction, transplant candidates, household communicators, cancer-related immunosuppression, health care professionals. Area under the curve was 0.836 and maximum error was 0.051. Users can make predictions with the following calculator: https://pedrobrasil.shinyapps.io/INDWELL/. The groups with lower seroprevalence should be evaluated more carefully regarding need for hepatitis A virus vaccination even when they seek immunization clinics for other purposes.


Subject(s)
Acquired Immunodeficiency Syndrome , Pregnancy , Female , Humans , Seroepidemiologic Studies , Brazil/epidemiology , Retrospective Studies , Parturition
6.
Cad. Saúde Pública (Online) ; 39(2): e00075522, 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1421022

ABSTRACT

The objectives were to estimate hepatitis A virus seroprevalence in subjects attending to a travel medicine and immunization clinic in Rio de Janeiro, Brazil, and to develop a prediction model for hepatitis A virus seroprevalence. This retrospective research included individuals sequentially from April 2011 to June 2019 at a travel medicine and special population immunization clinic with an anti-hepatitis A virus IgG chemiluminescence result. Participants' data were verified via electronic medical records. Data were split into development and validation set taking 2018 as the date break. A cross-validated elastic generalized linear model with binomial distribution was performed. In total, 2,944 subjects were analyzed. Hepatitis A virus overall seroprevalence was 67.8%. Health professionals, travelers, and those who had contact with immunocompromised subjects had lower seroprevalence (40%-55%), whereas subjects with chronic conditions (heart, lung, and liver) ranged from 89% to 94%. The retained predictors in the final model were sex, age, year of birth, travelers, HIV/AIDS, spleen dysfunction, transplant candidates, household communicators, cancer-related immunosuppression, health care professionals. Area under the curve was 0.836 and maximum error was 0.051. Users can make predictions with the following calculator: https://pedrobrasil.shinyapps.io/INDWELL/. The groups with lower seroprevalence should be evaluated more carefully regarding need for hepatitis A virus vaccination even when they seek immunization clinics for other purposes.


Este estudo teve como objetivo estimar a soroprevalência do vírus da hepatite A, em indivíduos atendidos em uma clínica de medicina de viagem e imunização no Rio de Janeiro, Brasil, e desenvolver um modelo de predição para a soroprevalência do vírus da hepatite A. Esta pesquisa retrospectiva incluiu indivíduos sequencialmente de abril de 2011 a junho de 2019, em uma clínica de medicina de viagem e uma clínica de vacinação de população especial, que, por qualquer motivo, tem um resultado de quimioluminescência IgG antivírus da hepatite A . Os dados dos participantes foram verificados em prontuário eletrônico. Os dados foram divididos em desenvolvimento e validação, tomando 2018 como data limite da divisão. Um modelo linear generalizado elástico com distribuição binomial submetido a validação cruzada foi aplicado. Foram analisados 2.944 indivíduos atendidos. A soroprevalência geral do vírus da hepatite A foi de 67,8%. Profissionais de saúde, viajantes e contatantes de indivíduos imunocomprometidos apresentaram menor soroprevalência, variando de 40% a 55%, enquanto indivíduos com condições crônicas (coração, pulmão e fígado) tiveram soroprevalência variando de 89% a 94%. Os preditores retidos no modelo final foram sexo, idade, ano de nascimento, viajantes, HIV/aids, asplenia funcional, candidatos a transplante, comunicante domiciliar, imunossupressão relacionada ao câncer e profissionais de saúde. A área sob a curva foi de 0,836 e o erro máximo foi de 0,051. Os usuários podem fazer previsões com uma calculadora (https://pedrobrasil.shinyapps.io/INDWELL/). Os grupos com menor soroprevalência devem ser avaliados com mais cuidado quanto à necessidade de vacinação contra o vírus da hepatite A, mesmo quando procuram clínicas de vacinação para outros fins.


Los objetivos del estudio son estimar la seroprevalencia de hepatitis A en sujetos que asisten a una clínica de medicina para viajeros e inmunización en Río de Janeiro, Brasil, y desarrollar un modelo de predicción de la seroprevalencia de hepatitis A. Esta investigación de seguimiento retrospectivo incluyó a individuos de forma secuencial desde abril de 2011 hasta junio de 2019 en una clínica de medicina para viajeros y de vacunación de poblaciones especiales que por cualquier motivo tienen un resultado de quimioluminiscencia IgG anti-hepatitis A. Los datos de los participantes se verificaron en los registros médicos electrónicos. Los datos se dividieron en conjunto de desarrollo y validación tomando 2018 como fecha de corte. Se realizó un modelo lineal generalizado validado cruzado elástico con distribución binomial. Se analizaron un total de 2.944 sujetos atendidos. La seroprevalencia global del hepatitis A fue del 67,8%. Los profesionales sanitarios, los viajeros y las personas en contacto con sujetos inmunodeprimidos presentaron una seroprevalencia más baja, que osciló entre el 40% y el 55%, mientras que los sujetos con afecciones crónicas (cardíacas, pulmonares y hepáticas) presentaron una seroprevalencia que varió entre el 89% y el 94%. Los predictores retenidos en el modelo final fueron el sexo, la edad, el año de nacimiento, los viajeros, el VIH/SIDA, la disfunción del bazo, los candidatos a trasplante, los comunicadores domésticos, la inmunosupresión relacionada con el cáncer y los profesionales sanitarios. Su área bajo la curva fue de 0,836 y el error máximo de 0,051. Los usuarios pueden hacer predicciones con una calculadora (https://pedrobrasil.shinyapps.io/INDWELL/). Los grupos con menor seroprevalencia deben ser evaluados más cuidadosamente en cuanto a la necesidad de vacunación contra hepatitis A, incluso cuando acudan a las clínicas de vacunación con otros fines.

7.
Front Public Health ; 10: 1017337, 2022.
Article in English | MEDLINE | ID: mdl-36457326

ABSTRACT

Background: A vaccination campaign targeted adults in response to the pandemic in the City of Rio de Janeiro. Objective: We aimed to evaluate the seroprevalence of SARS-CoV-2 antibodies and identify factors associated with seropositivity on vaccinated and unvaccinated residents. Methods: We performed a seroepidemiologic survey in all residents of Paquetá Island, a neighborhood of Rio de Janeiro city, during the COVID-19 vaccine roll-out. Serological tests were performed from June 16 to June 19, 2021, and adjusted seropositivity rates were estimated by age and epidemiological variables. Logistic regression models were used to estimate adjusted ORs for risk factors to SARS-CoV-2 seropositivity in non-vaccinated individuals, and potential determinants of the magnitude of antibody responses in the seropositive population. Results: We included in the study 3,016 residents of Paquetá (83.5% of the island population). The crude seroprevalence of COVID-19 antibodies in our sample was 53.6% (95% CI = 51.0, 56.3). The risk factors for SARS-CoV-2 seropositivity in non-vaccinated individuals were history of confirmed previous COVID-19 infection (OR = 4.74; 95% CI = 3.3, 7.0), being a household contact of a case (OR = 1.93; 95% CI = 1.5, 2.6) and in-person learning (OR = 2.01; 95% CI = 1.4, 3.0). Potential determinants of the magnitude of antibody responses among the seropositive were hybrid immunity, the type of vaccine received, and time since the last vaccine dose. Being vaccinated with Pfizer or AstraZeneca (Beta = 2.2; 95% CI = 1.8, 2.6) determined higher antibody titers than those observed with CoronaVac (Beta = 1.2; 95% CI = 0.9, 1.5). Conclusions: Our study highlights the impact of vaccination on COVID-19 collective immunity even in a highly affected population, showing the difference in antibody titers achieved with different vaccines and how they wane with time, reinforcing how these factors should be considered when estimating effectiveness of a vaccination program at any given time. We also found that hybrid immunity was superior to both infection-induced and vaccine-induced immunity alone, and online learning protected students from COVID-19 exposure.


Subject(s)
COVID-19 , Vaccines , Adult , Humans , SARS-CoV-2 , Seroepidemiologic Studies , Brazil/epidemiology , COVID-19 Vaccines , COVID-19/epidemiology , COVID-19/prevention & control
8.
Lancet Reg Health Am ; 14: 100335, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35991675

ABSTRACT

Background: There is limited information on the inequity of access to vaccination in low-and-middle-income countries during the COVID-19 pandemic. Here, we described the progression of the Brazilian immunisation program for COVID-19, and the association of socioeconomic development with vaccination rates, considering the potential protective effect of primary health care coverage. Methods: We performed an ecological analysis of COVID-19 immunisation data from the Brazilian National Immunization Program from January 17 to August 31, 2021. We analysed the dynamics of vaccine coverage in the adult population of 5,570 Brazilian municipalities. We estimated the association of human development index (HDI) levels (low, medium, and high) with age-sex standardised first dose coverage using a multivariable negative binomial regression model. We evaluated the interaction between the HDI and primary health care coverage. Finally, we compared the adjusted monthly progression of vaccination rates, hospital admission and in-hospital death rates among HDI levels. Findings: From January 17 to August 31, 2021, 202,427,355 COVID-19 vaccine doses were administered in Brazil. By the end of the period, 64·2% of adults had first and 31·4% second doses, with more than 90% of those aged ≥60 years with primary scheme completed. Four distinct vaccine platforms were used in the country, ChAdOx1-S/nCoV-19, Sinovac-CoronaVac, BNT162b2, Ad26.COV2.S, composing 44·8%, 33·2%, 19·6%, and 2·4% of total doses, respectively. First dose coverage differed between municipalities with high, medium, and low HDI (Median [interquartile range] 72 [66, 79], 68 [61, 75] and 63 [55, 70] doses per 100 people, respectively). Municipalities with low (Rate Ratio [RR, 95% confidence interval]: 0·87 [0·85-0·88]) and medium (RR [95% CI]: 0·94 [0·93-0·95]) development were independently associated with lower vaccination rates compared to those with high HDI. Primary health care coverage modified the association of HDI and vaccination rate, improving vaccination rates in those municipalities of low HDI and high primary health care coverage. Low HDI municipalities presented a delayed decrease in adjusted in-hospital death rates by first dose coverage compared to high HDI locations. Interpretation: In Brazil, socioeconomic disparities negatively impacted the first dose vaccination rate. However, the primary health care mitigated these disparities, suggesting that the primary health care coverage guarantees more equitable access to vaccines in vulnerable locations. Funding: This work is part of the Grand Challenges ICODA pilot initiative, delivered by Health Data Research UK and funded by the Bill & Melinda Gates Foundation and the Minderoo Foundation. This study was supported by the National Council for Scientific and Technological Development (CNPq), the Coordination for the Improvement of Higher Education Personnel (CAPES) - Finance Code 001, Carlos Chagas Filho Foundation for Research Support of the State of Rio de Janeiro (FAPERJ) and the Pontifical Catholic University of Rio de Janeiro.

9.
Front Pharmacol ; 13: 913568, 2022.
Article in English | MEDLINE | ID: mdl-35784694

ABSTRACT

Background: The consumption of antibiotics is one of the metrics used to evaluate the impact of antimicrobial stewardship programs (ASP). The aim of this study was to determine the prevalence of antibiotic consumption in Brazilian intensive care units (ICUs) and estimate the deviation of the prescribed daily dose (PDD) from the defined daily dose (DDD). Methods: This is a multicenter, observational, point-prevalence study carried out in adult ICUs of 8 Brazilian hospitals from August 2019, to February 2020. We collected data on the patient's demographic and clinical characteristics, antibiotic therapy, classification and site of infections. The DU90 (antibiotic accounting for 90% of the volume utilized) was calculated, and the antibiotics were classified by the Anatomical Therapeutic Chemical (ATC) Index and the World Health Organization (WHO) Access, Watch, Reserve (AWaRe) groups. For the most prevalent antibiotics, the deviation of PDD from DDD was determined. Results: Three hundred thirty-two patients from 35 ICUs were analyzed. The prevalence of antibiotic use was 52.4%. The patients in use of antibiotics were predominantly over 60 years of age (81.6%) with pulmonary infections (45.8%). A predominance of empirical regimens was observed (62.6%) among antibiotic therapies. The highest frequencies of prescriptions observed were for piperacillin + tazobactam (16.1%), meropenem (13.3%), amoxicillin + clavulanate (7.2%), azithromycin (7.2%), and teicoplanin (6.1%). The watch (64.2%) and reserve (9.6%) categories of the AWaRe classification accounted for 73.8% of all antibiotics, and they were prescribed alone or in combinations. High variability of doses was observed for the most prescribed antibiotics, and large deviations of PDD from the DDD were observed for meropenem, teicoplanin, and tigecycline. Conclusions: The high prevalence of antibiotic prescription was related to a predominance of empirical regimens and antibiotics belonging to the WHO Watch classification. High variability of doses and large deviations of PDD from DDD for meropenem, teicoplanin, and tigecycline was observed, suggesting that DDD may be insufficient to monitor the consumption of these antibiotics in the ICU population. The variability of doses found for the most prescribed antibiotics suggests the need for monitoring and intervention targets for antibiotic stewardship teams.

10.
Vaccine X ; 11: 100188, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35783330

ABSTRACT

The coronavirus disease 2019 pandemic abruptly changed the dynamics of basic health care, with the consequent need for adjustments in essential services. The objective of this study was to evaluate the acceptance and impact of telemedicine at a Reference Center for Special Immunobiologicals (CRIE). Methods: Patients aged 18 years or older who had a medical referral to CRIE and agreed to have a telemedicine consultation were included. After the medical appointments, participants answered a satisfaction survey. Results: From April 2021 to February 2022, 702 telemedicine consultation were conducted. Over 3,380 vaccines were prescribed via telemedicine. Of all the participants who answered the satisfaction questionnaire, 99.8% stated that they would recommend the service to other people. Conclusions: Telemedicine proved to be promising tool for healthcare at CRIE and had good acceptance by users, potentially improving access and extending the reach of the National Immunization Program.

11.
Clin Microbiol Infect ; 28(5): 736.e1-736.e4, 2022 May.
Article in English | MEDLINE | ID: mdl-35150884

ABSTRACT

OBJECTIVES: To estimate vaccine effectiveness after the first and second dose of ChAdOx1 nCoV-19 against symptomatic COVID-19 and infection in a socially vulnerable community in Brazil when Gamma and Delta were the predominant variants circulating. METHODS: We conducted a test-negative study in the community Complexo da Maré, the largest group of slums (n = 16) in Rio de Janeiro, Brazil, from January 17, 2021 to November 27, 2021. We selected RT-qPCR positive and negative tests from a broad community testing program. The primary outcome was symptomatic COVID-19 (positive RT-qPCR test with at least one symptom) and the secondary outcome was infection (any positive RT-qPCR test). Vaccine effectiveness was estimated as 1 - OR, which was obtained from adjusted logistic regression models. RESULTS: We included 10 077 RT-qPCR tests (6,394, 64% from symptomatic and 3,683, 36% from asymptomatic individuals). The mean age was 40 (SD: 14) years, and the median time between vaccination and RT-qPCR testing among vaccinated was 41 (25-75 percentile: 21-62) days for the first dose and 36 (25-75 percentile: 17-59) days for the second dose. Adjusted vaccine effectiveness against symptomatic COVID-19 was 31.6% (95% CI, 12.0-46.8) 21 days after the first dose and 65.1% (95% CI, 40.9-79.4) 14 days after the second dose. Adjusted vaccine effectiveness against COVID-19 infection was 31.0% (95% CI, 12.7-45.5) 21 days after the first dose and 59.0% (95% CI, 33.1-74.8) 14 days after the second dose. DISCUSSION: ChAdOx1 nCoV-19 was effective in reducing symptomatic COVID-19 in a socially vulnerable community in Brazil when Gamma and Delta were the predominant variants circulating.


Subject(s)
COVID-19 , Adult , BNT162 Vaccine , Brazil/epidemiology , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , ChAdOx1 nCoV-19 , Humans , SARS-CoV-2/genetics , Vaccine Efficacy
12.
Lancet ; 399(10323): 461-472, 2022 01 29.
Article in English | MEDLINE | ID: mdl-35065705

ABSTRACT

BACKGROUND: A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019. METHODS: This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 µg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020-004272-17) and ClinicalTrials.gov (NCT04672395). FINDINGS: 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8), 83·7% (97·86% CI 55·9-95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3-100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3-90·4) for delta, 91·8% (44·9-99·8) for gamma, and 58·6% (13·3-81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63-103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups. INTERPRETATION: Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant. FUNDING: Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.


Subject(s)
Adjuvants, Immunologic/therapeutic use , COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Spike Glycoprotein, Coronavirus/therapeutic use , Adolescent , Adult , Aged , Alum Compounds/therapeutic use , Belgium , Brazil , Colombia , Double-Blind Method , Female , Humans , Male , Middle Aged , Oligodeoxyribonucleotides/therapeutic use , Philippines , Protein Multimerization , Recombinant Proteins/therapeutic use , Risk , SARS-CoV-2 , South Africa , Vaccine Efficacy , Young Adult
13.
PLoS One ; 16(11): e0260551, 2021.
Article in English | MEDLINE | ID: mdl-34843551

ABSTRACT

BACKGROUND: Central nervous system infections (CNSI) are diseases with high morbidity and mortality, and their diagnosis in the intensive care environment can be challenging. Objective: To develop and validate a diagnostic model to quickly screen intensive care patients with suspected CNSI using readily available clinical data. METHODS: Derivation cohort: 783 patients admitted to an infectious diseases intensive care unit (ICU) in Oswaldo Cruz Foundation, Rio de Janeiro RJ, Brazil, for any reason, between 01/01/2012 and 06/30/2019, with a prevalence of 97 (12.4%) CNSI cases. Validation cohort 1: 163 patients prospectively collected, between 07/01/2019 and 07/01/2020, from the same ICU, with 15 (9.2%) CNSI cases. Validation cohort 2: 7,270 patients with 88 CNSI (1.21%) admitted to a neuro ICU in Chicago, IL, USA between 01/01/2014 and 06/30/2019. Prediction model: Multivariate logistic regression analysis was performed to construct the model, and Receiver Operating Characteristic (ROC) curve analysis was used for model validation. Eight predictors-age <56 years old, cerebrospinal fluid white blood cell count >2 cells/mm3, fever (≥38°C/100.4°F), focal neurologic deficit, Glasgow Coma Scale <14 points, AIDS/HIV, and seizure-were included in the development diagnostic model (P<0.05). RESULTS: The pool data's model had an Area Under the Receiver Operating Characteristics (AUC) curve of 0.892 (95% confidence interval 0.864-0.921, P<0.0001). CONCLUSIONS: A promising and straightforward screening tool for central nervous system infections, with few and readily available clinical variables, was developed and had good accuracy, with internal and external validity.


Subject(s)
Central Nervous System Infections/diagnosis , Adult , Aged , Brazil , Chicago , Critical Care , Female , Glasgow Coma Scale , Humans , Intensive Care Units , Logistic Models , Male , Middle Aged , Multivariate Analysis , Prognosis , ROC Curve , Retrospective Studies
14.
Rev Soc Bras Med Trop ; 53: e04312019, 2020.
Article in English | MEDLINE | ID: mdl-32401863

ABSTRACT

Since its re-emergence in the late 1990s, there have been reports of Chikungunya fever (CHIK-F) presenting with severe or atypical findings. There is little knowledge regarding the clinical events leading to the death of patients with CHIK-F. This study aimed to systematically review the literature regarding CHIK-F and identify clinical features preceding death. We searched PubMed, Scopus, Embase, Lilacs, and IsiWeb for case-reports, case-series, or cohorts of CHIK-F reporting at least one death, up to December 2019. Fifty-seven reports were analyzed, including 2140 deaths. Data about specific clinical events that precede death are scarce. The central tendency of time between disease onset and death ranged from 2 days to 150 days. The most common clinical findings among decedents were fever (22.0%), arthralgia (15.7%), myalgia (10.7%), and headache (8.2%). Excluding pediatric populations, the reported central tendency of age among the decedents was 53 or older, with a non-weighted median of 67, ranging up to 80 years old. Authors mentioned organic dysfunction in 91.2% reports. Among all the 2140 decedents, the most common dysfunctions were cardiovascular (7.2%), respiratory (6.4%), neurological (5.4%), renal (4.2%), liver (3.0%), and hematological (1.3%) dysfunction. Exacerbation of previous diabetes (5.6%) or hypertension (6.9%) was mentioned as conditions preceding death. Currently, older age, primary neurological, cardiovascular, or respiratory dysfunction and a previous diagnosis of diabetes or hypertension are the main clinical events preceding death.


Subject(s)
Chikungunya Fever/mortality , Aged , Aged, 80 and over , Cause of Death , Chikungunya Fever/complications , Disease Progression , Humans , Middle Aged
15.
Cad Saude Publica ; 36(1): e00149119, 2020.
Article in English | MEDLINE | ID: mdl-31967286

ABSTRACT

Varicella in adults and immunocompromised patients can be severe. The clinical diagnosis of varicella has high accuracy and the history of disease has a high positive predictive value for protection. A significant portion of adults, however, cannot remember if they have had varicella, especially older individuals. We conducted a cross-sectional study to determine the seroprevalence of varicella protective antibodies titers in adults with no clinical history of disease, attended at a Reference Center for Special Immunobiologicals and Travel Medicine in Rio de Janeiro (Brazil). Titration of immunoglobulin G (IgG) antibodies to varicella-zoster was determined by chemiluminescence immunoassay. Among 140 adults without history of varicella, 92% had protective antibody titers. We concluded that seroprevalence of varicella-zoster protection was very high in adults with negative history of disease and the use of serology before vaccination reduced significantly unnecessary vaccine and immunoglobulin use.


Subject(s)
Chickenpox/epidemiology , Herpesvirus 3, Human/immunology , Immunoglobulin G/blood , Adult , Antibodies, Viral/blood , Brazil/epidemiology , Chickenpox/blood , Chickenpox/prevention & control , Chickenpox Vaccine , Cross-Sectional Studies , Humans , Luminescent Measurements , Prevalence , Seroepidemiologic Studies
16.
Ocul Immunol Inflamm ; 28(6): 952-955, 2020 Aug 17.
Article in English | MEDLINE | ID: mdl-31567025

ABSTRACT

PURPOSE: To describe a case of Acute Zika infection with ocular involvementMethods: Review of clinical recordsResults: Patient presented with sudden blurred vision in both eyes during an acute episode of zika virus infection. Ophthalmological examination revealed clinical picture of multifocal choroiditis in both eyes. Lesions improved and visual acuities returned to normal level without any treatment.Conclusion: Ocular changes in acute Zika virus infection is a rare condition. Patiens may present spontaneous recovery.


Subject(s)
Eye Infections, Viral/virology , Multifocal Choroiditis/virology , Zika Virus Infection/virology , Acute Disease , Eye Infections, Viral/diagnostic imaging , Female , Humans , Middle Aged , Multifocal Choroiditis/diagnostic imaging , Tomography, Optical Coherence , Visual Acuity/physiology , Zika Virus Infection/diagnostic imaging
17.
Rev. Soc. Bras. Med. Trop ; 53: e04312019, 2020. tab, graf
Article in English | Sec. Est. Saúde SP, Coleciona SUS, LILACS | ID: biblio-1136839

ABSTRACT

Abstract Since its re-emergence in the late 1990s, there have been reports of Chikungunya fever (CHIK-F) presenting with severe or atypical findings. There is little knowledge regarding the clinical events leading to the death of patients with CHIK-F. This study aimed to systematically review the literature regarding CHIK-F and identify clinical features preceding death. We searched PubMed, Scopus, Embase, Lilacs, and IsiWeb for case-reports, case-series, or cohorts of CHIK-F reporting at least one death, up to December 2019. Fifty-seven reports were analyzed, including 2140 deaths. Data about specific clinical events that precede death are scarce. The central tendency of time between disease onset and death ranged from 2 days to 150 days. The most common clinical findings among decedents were fever (22.0%), arthralgia (15.7%), myalgia (10.7%), and headache (8.2%). Excluding pediatric populations, the reported central tendency of age among the decedents was 53 or older, with a non-weighted median of 67, ranging up to 80 years old. Authors mentioned organic dysfunction in 91.2% reports. Among all the 2140 decedents, the most common dysfunctions were cardiovascular (7.2%), respiratory (6.4%), neurological (5.4%), renal (4.2%), liver (3.0%), and hematological (1.3%) dysfunction. Exacerbation of previous diabetes (5.6%) or hypertension (6.9%) was mentioned as conditions preceding death. Currently, older age, primary neurological, cardiovascular, or respiratory dysfunction and a previous diagnosis of diabetes or hypertension are the main clinical events preceding death.


Subject(s)
Humans , Aged , Aged, 80 and over , Chikungunya Fever/mortality , Cause of Death , Disease Progression , Chikungunya Fever/complications , Middle Aged
18.
Cad. Saúde Pública (Online) ; 36(1): e00149119, 2020. tab
Article in English | LILACS | ID: biblio-1055626

ABSTRACT

Abstract: Varicella in adults and immunocompromised patients can be severe. The clinical diagnosis of varicella has high accuracy and the history of disease has a high positive predictive value for protection. A significant portion of adults, however, cannot remember if they have had varicella, especially older individuals. We conducted a cross-sectional study to determine the seroprevalence of varicella protective antibodies titers in adults with no clinical history of disease, attended at a Reference Center for Special Immunobiologicals and Travel Medicine in Rio de Janeiro (Brazil). Titration of immunoglobulin G (IgG) antibodies to varicella-zoster was determined by chemiluminescence immunoassay. Among 140 adults without history of varicella, 92% had protective antibody titers. We concluded that seroprevalence of varicella-zoster protection was very high in adults with negative history of disease and the use of serology before vaccination reduced significantly unnecessary vaccine and immunoglobulin use.


Resumo: A varicela é uma doença potencialmente grave em adultos e em pacientes imunocomprometidos. O diagnóstico clínico da varicela apresenta alta acurácia, e o relato da doença na história individual tem alto valor preditivo positivo para a proteção. Entretanto, uma proporção significativa de adultos, principalmente os mais idosos, não se lembra se já teve a doença. Realizamos um estudo transversal para determinar a soroprevalência de títulos protetores de anticorpos contra a varicela em adultos sem história clínica da doença, atendidos em um Centro de Referência para Imunobiológicos Especiais e Medicina de Viagem no Rio de Janeiro, Brasil. Os títulos da imunoglobulina G (IgG) contra varicela-zoster foram determinados por quimiluminescência. Entre 140 adultos sem história de varicela, 92% apresentaram títulos protetores de anticorpos. Concluímos que a soroprevalência de proteção contra varicela-zoster é muito alta em adultos sem história da doença, e que o uso de teste sorológico antes da vacinação reduziria significativamente a vacinação desnecessária e o uso de imunoglobulina.


Resumen: La varicela en adultos y pacientes inmunocomprometidos puede ser grave. El diagnóstico clínico de la varicela tiene una gran precisión y la historia de la enfermedad cuenta con un alto valor predictivo positivo para la protección contra ella. Sin embargo, un porcentaje significativo de adultos, no puede recordar si tuvieron varicela, especialmente las personas más viejas. Realizamos un estudio transversal para determinar la seroprevalencia de las concentraciones de anticuerpos protectores frente a la varicela, en adultos sin historia clínica de la enfermedad, que se llevó a cabo en un Centro de Referencia para Inmunobiología Especial y Medicina del Viajero en Río de Janeiro (Brasil). Se determinó la valoración de los anticuerpos de inmunoglobulina G (IgG) a la varicela-zoster mediante un ensayo inmunológico quimioluminiscente. Entre 140 adultos sin historial de varicela, un 92% tuvieron concentraciones de anticuerpos protectores. Concluimos que la seroprevalencia de la protección a la varicela-zoster fue muy alta en adultos con un historial negativo de la enfermedad y la utilización de la serología antes de la vacunación redujo de manera significativa la vacunación innecesaria y el uso de la inmunoglobulina.


Subject(s)
Humans , Adult , Immunoglobulin G/blood , Chickenpox/epidemiology , Herpesvirus 3, Human/immunology , Brazil/epidemiology , Chickenpox/prevention & control , Chickenpox/blood , Prevalence , Cross-Sectional Studies , Chickenpox Vaccine , Luminescent Measurements , Antibodies, Viral/blood
19.
Rev Soc Bras Med Trop ; 52: e20180514, 2019 May 16.
Article in English | MEDLINE | ID: mdl-31141055

ABSTRACT

INTRODUCTION: Travel medicine is aimed at promoting health risk reduction. However, travelers' perception of risk is subjective and may influence implementation of recommendations. This study reports on travelers' perception of risk, pre-travel characteristics, and recommended interventions. METHODS: This is a descriptive cross-sectional study. RESULTS: This study included 111 individuals. Most travelers (74%) perceived their risk as low. Significant differences in travel-related risk perception between practitioners and travelers were observed (Gwet's agreement coefficient [AC1] 0.23; standard error 0.10; 95% confidence interval 0.02-0.44). CONCLUSIONS: Future studies should investigate the relationship between travelers' perception of risk and implementation of recommendations.


Subject(s)
Health Knowledge, Attitudes, Practice , Travel-Related Illness , Travel/statistics & numerical data , Adult , Brazil , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Risk Assessment , Socioeconomic Factors , Vaccines/administration & dosage
20.
Sci Rep ; 9(1): 2760, 2019 02 26.
Article in English | MEDLINE | ID: mdl-30809003

ABSTRACT

Brazil, which is hyperendemic for dengue virus (DENV), has had recent Zika (ZIKV) and (CHIKV) Chikungunya virus outbreaks. Since March 2016, CHIKV is the arbovirus infection most frequently diagnosed in Rio de Janeiro. In the analysis of 1835 syndromic patients, screened by real time RT-PCR, 56.4% of the cases were attributed to CHIKV, 29.6% to ZIKV, and 14.1% to DENV-4. Sequence analyses of CHIKV from sixteen samples revealed that the East-Central-South-African (ECSA) genotype of CHIKV has been circulating in Brazil since 2013 [95% bayesian credible interval (BCI): 03/2012-10/2013], almost a year before it was detected by arbovirus surveillance program. Brazilian cases are related to Central African Republic sequences from 1980's. To the best of our knowledge, given the available sequence published here and elsewhere, the ECSA genotype was likely introduced to Rio de Janeiro early on 2014 (02/2014; BCI: 07/2013-08/2014) through a single event, after primary circulation in the Bahia state at the Northestern Brazil in the previous year. The observation that the ECSA genotype of CHIKV was circulating undetected underscores the need for improvements in molecular methods for viral surveillance.


Subject(s)
Chikungunya Fever/diagnosis , Chikungunya virus/genetics , Bayes Theorem , Brazil/epidemiology , Chikungunya Fever/epidemiology , Chikungunya Fever/virology , Chikungunya virus/classification , Chikungunya virus/isolation & purification , Genotype , High-Throughput Nucleotide Sequencing , Humans , Phylogeny , RNA, Viral/chemistry , RNA, Viral/metabolism , Sequence Analysis, RNA
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