Humoral and cellular response induced by a second booster of an inactivated SARS-CoV-2 vaccine in adults

The SARS-CoV-2 Omicron variant has challenged the control of the COVID-19 pandemic even in highly vaccinated countries. While a second booster of mRNA vaccines improved the immunity against SARS-CoV-2, the humoral and cellular responses induced by a second booster of an inactivated SARS-CoV-2 vaccine have not been studied. In the context of a phase 3 clinical study, we report that a second booster of CoronaVac(R) increased the neutralizing response against the ancestral virus yet showed poor neutralization against the Omicron variant. Additionally, isolated PBMCs displayed equivalent activation of specific CD4+ T cells and IFN-{gamma} production when stimulated with a mega-pool of peptides derived from the spike protein of the ancestral virus or the Omicron variant. In conclusion, a second booster dose of CoronaVac(R) does not improve the neutralizing response against the Omicron variant compared with the first booster dose, yet it helps maintaining a robust spike-specific CD4+ T cell response.

Differential immune response induced by two immunization schedules with an inactivated SARS-CoV-2 vaccine in a randomized phase 3 clinical trial

BackgroundThe development of vaccines to control the COVID-19 pandemic progression is a worldwide priority. CoronaVac(R) is an inactivated SARS-CoV-2 vaccine approved for emergency use with robust efficacy and immunogenicity data reported in trials in China, Brazil, Indonesia, Turkey, and Chile. MethodsThis study is a randomized, multicenter, and controlled phase 3 trial in healthy Chilean adults aged [≥]18 years. Volunteers received two doses of CoronaVac(R) separated by two (0-14 schedule) or four weeks (0-28 schedule). 2,302 volunteers were enrolled, 440 were part of the immunogenicity arm, and blood samples were obtained at different times. Samples from a single center are reported. Humoral immune responses were evaluated by measuring the neutralizing capacities of circulating antibodies. Cellular immune responses were assessed by ELISPOT and flow cytometry. Correlation matrixes were performed to evaluate correlations in the data measured. ResultsBoth schedules exhibited robust neutralizing capacities with the response induced by the 0-28 schedule being better. No differences were found in the concentration of antibodies against the virus and different variants of concern between schedules. Stimulation of PBMCs with MPs induced the secretion of IFN-{gamma} and the expression of activation induced markers for both schedules. Correlation matrixes showed strong correlations between neutralizing antibodies and IFN-{gamma} secretion. ConclusionsImmunization with CoronaVac(R) in Chilean adults promotes robust cellular and humoral immune responses. The 0-28 schedule induced a stronger humoral immune response than the 0-14 schedule. FundingMinistry of Health, Government of Chile, Confederation of Production and Commerce & Millennium Institute on Immunology and Immunotherapy, Chile. Clinical trial numberNCT04651790. summaryTwo immunization schedules were evaluated for the inactivated SARS-CoV-2 vaccine, Coronavac(R), with two doses of the vaccine separated by two or four weeks. We compared humoral and cellular immune responses, showing they are mostly similar, with differences in neutralization capacities.

Impactos psicológicos da mastectomia: Uma análise na Associação de Apoio a Pessoa com Câncer / Psychological impacts of mastectomy: An analysis in the Associação de Apoio a Pessoa com Câncer / Impactos psicológicos de la mastectomía: Un análisis en la Associação de Apoio a Pessoa com Câncer

O câncer de mama tem maior incidência em mulheres no Brasil. A mastectomia é uma das possibilidades de tratamento, porém com repercussões na saúde física e psíquica da mulher. Foi objetivo desta pesquisa descrever os principais impactos da mastectomia em mulheres acolhidas na Associação de Apoio à Pessoa com Câncer (AAPC) na Bahia. Trata-se de um estudo qualitativo, descritivo, realizado com dez mulheres entre 32 e 63 anos, mastectomizadas e que frequentavam a associação. Foi realizada entrevista semisestruturada individual, e os dados foram analisados por meio da técnica de análise de conteúdo de Bardin. Após análise, foram extraídas três categorias: (1) sentimentos diante do diagnóstico e tratamento da neoplasia; (2) luto simbólico e impactos na autoestima das mulheres mastectomizadas; e (3) estratégias de enfrentamento diante da mastectomia. Os sentimentos identificados foram tristeza, medo, desespero, aceitação, fé e esperança. Houve vivência do luto simbólico e impacto na autoestima devido à mastectomia e perda de cabelo. Já as estratégias de enfrentamento do adoecimento foram o fortalecimento de redes de apoio, a espiritualidade, a significação do processo via trabalho voluntário e o apoio da equipe de saúde. Conclui-se que são muitos os impactos psicológicos do adoecimento e do tratamento, sendo o acompanhamento psicológico um cuidado potencial.

Breast cancer has the highest incidence in women in Brazil. Mastectomy is one of the treatment possibilities but with repercussions on the physical and psychological health of the woman. This research aimed to describe the main impacts of mastectomy in women welcomed at the Cancer Support Association (AAPC) in Bahia. This is a qualitative, descriptive study carried out with ten women between 32 and 63 years old, who underwent mastectomy and who attended the association. An individual semi-structured interview was carried out, and the data were analyzed by using Bardin's content analysis technique. After analysis, three categories were extracted: (1) feelings about the diagnosis and treatment of the neoplasm; (2) symbolic mourning and impacts on mastectomy women's self-esteem; and (3) coping strategies in face of mastectomy. The feelings identified were sadness, fear, despair, acceptance, faith, and hope. Symbolic mourning and impact on self-esteem due to mastectomy and hair loss were experienced. The strategies for coping with illness were the strengthening of support networks, spirituality, giving meaning to the process with volunteer work and the support from the health team. In conclusion, the psychological impacts of illness and treatment are many, and psychological support is a potential care.

El cáncer de mama tiene mayor incidencia en mujeres en Brasil. La mastectomía es una de las posibilidades de tratamiento, pero con repercusiones en la salud física y psíquica de la mujer. El objetivo de esta investigación fue describir los principales impactos de la mastectomía en mujeres acogidas en la Associação de Apoio à Pessoa com Câncer (AAPC) en Bahia. Se trata de un estudio cualitativo, descriptivo, realizado con diez mujeres entre 32 y 63 años, operadas de mastectomía y que asistían a la asociación. Se realizó una entrevista individual semiestructurada y se analizaron los datos mediante la técnica de análisis de contenido de Bardin. Después del análisis, se extrajeron tres categorías: (1) sentimientos sobre el diagnóstico y tratamiento de la neoplasia; (2) duelo simbólico e impactos en la autoestima de mujeres mastectomizadas; y estrategias de afrontamiento ante la mastectomía. Los sentimientos identificados fueron tristeza, miedo, desesperación, aceptación, fe y esperanza. Hubo vivencia de duelo simbólico e impacto en la autoestima por mastectomía y caída del cabello. A su vez, las estrategias de enfrentamiento de la enfermedad fueron el fortalecimiento de las redes de apoyo, la espiritualidad, el sentido del proceso a través del trabajo voluntario y el apoyo del equipo de salud. Se concluye que hay muchos impactos psicológicos de la enfermedad y el tratamiento, siendo el apoyo psicológico un cuidado potencial.

An inactivated SARS-CoV-2 vaccine is safe and induces humoral and cellular immunity against virus variants in healthy children and adolescents in Chile

BackgroundMultiple vaccines against SARS-CoV-2 have been evaluated in clinical trials, but very few include the pediatric population. The inactivated vaccine CoronaVac(R) has shown to be safe and immunogenic in a phase 1/2 clinical trial in a pediatric cohort in China. This study is an interim safety and immunogenicity report of a phase 3 clinical trial for CoronaVac(R) in healthy children and adolescents in Chile. MethodsParticipants aged 3 to 17 years old received two doses of CoronaVac(R) in a four-week interval. Local and systemic adverse reactions were registered in 699 participants that received the first dose and 381 that received the second dose until December 31st, 2021. Whole blood samples were collected from 148 participants for humoral and cellular immunity analyses. ResultsThe primary adverse reaction reported after the first and second dose was pain at the injection site. The adverse reactions observed were primarily mild and local, and no severe adverse events were reported. Four weeks after the second dose, a significant increase in the levels of total and neutralizing antibodies was observed. Increased activation of specific CD4+ T cells was also observed four weeks after the second dose. Although antibodies induced by vaccination neutralize variants Delta and Omicron, titers were lower than the D614G variant. Importantly, comparable T cell responses were detected against these variants of concern. ConclusionsCoronaVac(R) is safe and immunogenic in subjects aged 3-17 years old and is thus likely to confer protection against infection caused by SARS-CoV-2 variants in this target population.

A booster dose of an inactivated vaccine increases neutralizing antibodies and T cell responses against SARS-CoV-2

BackgroundCoronaVac(R) is an inactivated SARS-CoV-2 vaccine approved by the World Health Organization. Previous studies reported increased levels of neutralizing antibodies and specific T cells two- and four-weeks after two doses of CoronaVac(R), but the levels of neutralizing antibodies are reduced at six to eight months after two doses. Here we report the effect of a booster dose of CoronaVac(R) on the anti-SARS-CoV-2 immune response generated against variants of concern (VOC) Delta and Omicron in adults participating in a phase 3 clinical trial in Chile. MethodsVolunteers immunized with two doses of CoronaVac(R) in a four-week interval received a booster dose of the same vaccine between twenty-four and thirty weeks after the 2nd dose. Four weeks after the booster dose, neutralizing antibodies and T cell responses were measured. Neutralization capacities and T cell activation against VOC Delta and Omicron were detected at four weeks after the booster dose. FindingsWe observed a significant increase in neutralizing antibodies at four weeks after the booster dose. We also observed an increase in CD4+ T cells numbers over time, reaching a peak at four weeks after the booster dose. Furthermore, neutralizing antibodies and SARS-CoV-2 specific T cells induced by the booster showed activity against VOC Delta and Omicron. InterpretationOur results show that a booster dose of CoronaVac(R) increases the anti-SARS-CoV-2 humoral and cellular immune responses in adults. Immunity induced by a booster dose of CoronaVac(R) is active against VOC, suggesting an effective protection.

Interim Report: Safety And Immunogenicity Of An Inactivated Vaccine Against Sars-Cov-2 In Healthy Chilean Adults In A Phase 3 Clinical Trial

BackgroundThe ongoing COVID-19 pandemic has had a significant impact worldwide, with an incommensurable social and economic burden. The rapid development of safe and protective vaccines against this disease is a global priority. CoronaVac is a vaccine prototype based on inactivated SARS-CoV-2, which has shown promising safety and immunogenicity profiles in pre-clinical studies and phase 1/2 trials in China. To this day, four phase 3 clinical trials are ongoing with CoronaVac in Brazil, Indonesia, Turkey, and Chile. This article reports the safety and immunogenicity results obtained in a subgroup of participants aged 18 years and older enrolled in the phase 3 Clinical Trial held in Chile. MethodsThis is a multicenter phase 3 clinical trial. Healthcare workers aged 18 years and older were randomly assigned to receive two doses of CoronaVac or placebo separated by two weeks (0-14). We report preliminary safety results obtained for a subset of 434 participants, and antibody and cell-mediated immunity results obtained in a subset of participants assigned to the immunogenicity arm. The primary and secondary aims of the study include the evaluation of safety parameters and immunogenicity against SARS-CoV-2 after immunization, respectively. This trial is registered at clinicaltrials.gov (NCT04651790). FindingsThe recruitment of participants occurred between November 27th, 2020, until January 9th, 2021. 434 participants were enrolled, 397 were 18-59 years old, and 37 were [≥]60 years old. Of these, 270 were immunized with CoronaVac, and the remaining 164 participants were inoculated with the corresponding placebo. The primary adverse reaction was pain at the injection site, with a higher incidence in the vaccine arm (55.6%) than in the placebo arm (40.0%). Moreover, the incidence of pain at the injection site in the 18-59 years old group was 58.4% as compared to 32.0% in the [≥]60 years old group. The seroconversion rate for specific anti-S1-RBD IgG was 47.8% for the 18-59 years old group 14 days post immunization (p.i.) and 95.6% 28 and 42 days p.i. For the [≥]60 years old group, the seroconversion rate was 18.1%, 100%, and 87.5% at 14, 28, and 42 days p.i., respectively. Importantly, we observed a 95.7% seroconversion rate in neutralizing antibodies for the 18-59 years old group 28 and 42 days p.i. The [≥]60 years old group exhibited seroconversion rates of 90.0% and 100% at 28 and 42 days p.i. Interestingly, we did not observe a significant seroconversion rate of anti-N-SARS-CoV-2 IgG for the 18-59 years old group. For the participants [≥]60 years old, a modest rate of seroconversion at 42 days p.i. was observed (37.5%). We observed a significant induction of a T cell response characterized by the secretion of IFN-{gamma} upon stimulation with Mega Pools of peptides derived from SARS-CoV-2 proteins. No significant differences between the two age groups were observed for cell-mediated immunity. InterpretationImmunization with CoronaVac in a 0-14 schedule in adults of 18 years and older in the Chilean population is safe and induces specific IgG production against the S1-RBD with neutralizing capacity, as well as the activation of T cells secreting IFN-{gamma}, upon recognition of SARS-CoV-2 antigens. FundingMinistry of Health of the Chilean Government; Confederation of Production and Commerce, Chile; Consortium of Universities for Vaccines and Therapies against COVID-19, Chile; Millennium Institute on Immunology and Immunotherapy.

Relação entre cefaleia e o uso de equipamentos de proteção individual em cirurgiões-dentistas e médicos do Rio Grande do Norte durante a COVID-19 / Relationship between headache and the use of personal protective equipment in dentists and doctors in Rio Grande do Norte during COVID-19

Introdução: O estado de alerta provocado pela doença do novo Coronavírus (COVID-19) pode impactar negativamente na saúde dos indivíduos. Os profissionais da saúde estão expostos à contaminação pelo vírus, em especial os Cirurgiões-Dentistas e Médicos, que atuam em ambiente hospitalar, devido a sua forma de atuação frequente próxima ao paciente. Sabe-se que a cefaleia pode estar relacionada aos equipamentos de proteção individuais (EPIS) utilizados no dia a dia desses profissionais. Objetivo: O presente estudo busca avaliar a associação da cefaleia e o uso de equipamentos de proteção individual em Cirurgiões-Dentistas e Médicos no Rio Grande do Norte. Metodologia: Foi realizado um estudo do tipo observacional, analítico e transversal com cirurgiões dentistas e médicos convidados a participar da pesquisa via mensagens eletrônicas através do Google formulários acerca de sinais e sintomas, através do questionário para cefaleia (Questionário de dores de cabeça associadas a equipamentos de proteção individual - Adaptado). Para análise estatística os dados foram reunidos em um banco de dados criado no programa Statistical Package for the Social Science (SPSS) 22.0. Foram realizados testes Qui quadrado de Pearson e Fischer para o cruzamento das variáveis, com um intervalo de confiança de 95%. Resultados: A amostra do estudo foi composta por 181 profissionais, sendo 23,2% médicos (n=42) e 76,8% cirurgiões dentistas (n=139), 34,8% (n=63) do gênero masculino e 65,2% (n=118) do gênero feminino. 84% (n=152) dos profissionais atuavam em ambiente ambulatorial. 43,6% dos profissionais (n=79) relataram uma resposta positiva à cefaleia. Um aumento do uso dos EPIS (87,3% n=158) (p=0,183), uso de máscaras faciais com óculos ou viseiras (96,7% n=175), (p=0,234) ou máscaras N95 ou PFF-2 (88,4% n=160) (p=0,062) não foram relacionados à cefaleia. Porém, seu uso por 5 horas ou mais (58,6% n=106) (p<0,01) foram estatisticamente significativos. Relatos de cefaleias bilaterais, dor na região parietal e temporal e em toda a cabeça, qualidade da dor, intervalo de tempo e intensidade, foram significativos para o desenvolvimento da cefaleia devido ao uso dos EPIs. Conclusões: Baseado em nosso estudo, o aumento da utilização dos EPIs não influenciou estatisticamente nos quadros de cefaleia. Observou-se que o tipo de máscara utilizada, não influenciou os relatos de cefaleias e observou-se um aumento nos relatos de cefaleias naqueles profissionais que os utilizava por cerca de cinco horas ou mais (AU).

Introduction: The alertness caused by the disease of the new Coronavirus (COVID-19) can have a negative impact on the health of individuals. Health professionals are exposed to the contamination by the virus, especially the Dental Surgeons and Doctors, who work in a hospital environment, due to their frequent action close to the patient. It is known that headache may be related to individual protective equipment (EPIS) used in the daily lives of these professionals. Objective: The present study seeks to evaluate the association of headache and the use of personal protective equipment in Dental Surgeons and Doctors in Rio Grande do Norte. Methodology: An observational, analytical and cross-sectional study was carried out with dental surgeons and doctors invited to participate in the survey via electronic messages through Google forms about signs and symptoms, through the questionnaire for headache (Questionnaire of headaches associated with equipment personal protection - Adapted). For statistical analysis the data were gathered in a database created in the program Statistical Package for the Social Science (SPSS) 22.0. Pearson and Fischer Chi-square tests were performed to cross the variables, with a 95% confidence interval. Results: The study sample consisted of 181 professionals, being 23.2% doctors (n = 42) and 76.8% dentists (n = 139), 34.8% (n = 63) male and 65 , 2% (n = 118) of the female gender. 84% (n = 152) of the professionals worked in an outpatient setting. 43.6% of professionals (n = 79) reported a positive response to headache. An increase in the use of EPIS (87.3% n = 158) (p = 0.183), use of facial masks with glasses or visors (96.7% n = 175), (p = 0.234) or N95 or PFF- masks 2 (88.4% n = 160) (p = 0.062) were not related to headache. However, its use for 5 hours or more (58.6% n = 106) (p <0.01) was statistically significant. Reports of bilateral headache, pain in the parietal and temporal region and throughout the head, quality of pain, time interval and intensity, were significant for the development of headache due to the use of PPE. Conclusions: Based on our study, the increased use of PPE did not statistically influence headache. It was observed that the type of mask used did not influence the headache reports and there was an increase in headache reports in those professionals who used them for about five hours or more (AU).

Concordância entre índices de necessidade de tratamento ortodôntico em estudo de base populacional com adolescentes escolares / Agreement between indexes of orthodontic treatment need in population based study with teenager students

Diversos índices analisam a prevalência das oclusopatias, sendo métodos de avaliar a necessidade e priorização do tratamento ortodôntico. Baseado nas possíveis divergências, este estudo avaliou a concordância entre o ICON (Índice de Complexidade, Efeito e Necessidade de Tratamento Ortodôntico), DHC (Componente de Saúde Dental) do IOTN (Índice de Necessidade de Tratamento Ortodôntico), AC (Componente de Estética Dental) do examinador e DAI (Índice de Estética Dental) ao diagnosticarem indivíduos com ou sem necessidade de tratamento para oclusopatias e em seus graus de severidade. Examinou-se 300 estudantes de 15 a 19 anos de Macaíba/RN. A concordância para a categorização com ou sem necessidade foi dada pelo Kappa, e para severidade através do coeficiente W de Kendall com significância de 5%. A prevalência de necessidade de tratamento foi de 76% no DAI, 31% no ICON, 73,7% no DHC e 29,3% no AC. O Kappa não foi significativo (k=0,054; p=0,351) ao comparar o DAI com DHC. Outras comparações foram significativas (p<0,001), com concordância fraca (k=0,148-0,158), exceção a do ICON com AC (k=0,866). A concordância no coeficiente W de Kendall foi fraca (w=0,365), embora significativa (p<0,001). Há classificação divergente para a necessidade de tratamento ortodôntico ao utilizar diferentes índices, com consequências ao diagnóstico e priorização do tratamento em nível populacional e individual.(AU)

everal indices analyse the prevalence of malocclusion as methods of evaluating and prioritizing orthodontic treatment need. Based on possible divergences, this study examined the correlation between ICON (Complexity Index, Effect and Need Orthodontic Treatment), DHC (Dental Health Component), IOTN (Index of Orthodontic Treatment Need), AC (Component Dental Aesthetics) of examiner and DAI (Dental Aesthetic Index) to diagnose individuals with or without treatment need for malocclusion and its severity degree. We examined 300 students from 15 to 19 years of Macaíba/RN. The agreement for the categorization with or without treatment need was given by Kappa coefficient and for severity by Kendall W coeficient with 5% significance. The prevalence of treatment need was 76% in the DAI, 31% in the ICON, 73.7% in the DHC and 29.3% in the AC. Kappa was not significant (k = 0.054, p = 0.351) when comparing the DAI with DHC. Other comparisons were significant (p <0.001), with weak agreement (k = 0.148 to 0.158), exception to the ICON with AC (k = 0.866). The coefficient correlation in W Kendall was weak (w = 0.365), although significant (p <0.001). There is divergent classification for orthodontic treatment need when using different indices, with implications for diagnosis and treatment priority in individual and population level.(AU)