The wet nurses of the Hospital Real of Santiago de Compostela between 1803 and 1808 / Las nodrizas del Hospital Real de Santiago de Compostela entre 1803 y 1808 / As amas de leite do Hospital Real de Santiago de Compostela entre 1803 e 1808

Objective. To analyze the duties of wet nurses at the Hospital Real in Santiago de Compostela (Spain). The secondary objectives were to compare the mortality rate and distribution by parish of the foundlings under the care of the Royal House between 1803 and 1808; and to determine the origin of the Galician foundlings who participated in the Royal Philanthropic Expedition of the Smallpox Vaccine in 1803. Methods. Historiographic study that analyzed sorted and not sorted in series indirect positional and quantitative historical sources.Results. The duties of wet nurses during the studied period were to provide basic care and cultural instruction. The mortality rate of foundlings fluctuated during that period and their distribution by parish (functional unit of healthcare services at that time) was similar in those years, with a predominance in the provinces of A Coruña and Pontevedra. A total of 5 Galician foundlings from the House analyzed were part of the smallpox vaccine expedition, their names were Juan Antonio, Jacinto, Gerónimo María, Francisco Florencio and Juan Francisco. Conclusion. During the observed period the wet nurses of the Hospital Real of Santiago de Compostela were in charge of pediatric care. Wet nurses were vital in the role of keeping the foundlings alive and can be considered as one of the forerunners of the pediatric nurse profession at that time.

Objetivo. analizar las funciones que realizaban las amas de leche en el Hospital Real de Santiago de Compostela (España). Los objetivos secundarios han sido: comparar la mortalidad y distribución por parroquias de los niños expósitos a cargo de la Real Casa entre 1803 y 1808, determinar la procedencia de los niños expósitos gallegos que participaron en la Real Expedición Filantrópica de la Vacuna de la viruela en 1803. Métodos. Estudio historiográfico que analizó fuentes históricas posicionales indirectas y cuantitativas seriadas y no seriadas. Resultados. las funciones de las nodrizas durante el período de estudio eran proporcionar los cuidados básicos e instrucción cultural; la mortalidad de los expósitos sufrió oscilaciones a lo largo del período analizado. La distribución por parroquias (unidad funcional de las áreas de salud en la época) fue similar en estos años, con predominancia de las provincias de A Coruña y Pontevedra. Un total de 5 niños expósitos gallegos de la Casa analizada han participado en la expedición filantrópica de la viruela, sus nombres fueron: Juan Antonio, Jacinto, Gerónimo María, Francisco Florencio y Juan Francisco. Conclusión. Durante el período de observación, las amas de leche del Hospital Real de Santiago de Compostela realizaban cuidados pediátricos. Las nodrizas cumplieron un rol fundamental para el mantenimiento con vida de los niños expósitos y pueden ser consideradas como una de las figuras precursoras de la profesión enfermera pediátrica en la época.

Objetivo. Analisar as funções desempenhadas pelas nutrizes no Hospital Real de Santiago de Compostela (Espanha). Os objetivos secundários foram: comparar a mortalidade e distribuição por freguesia dos enjeitados responsáveis pela Casa Real entre 1803 e 1808, determinar a origem dos enjeitados galegos que participaram na Real Expedição Filantrópica da Vacina contra a Varíola em 1803. Métodos. Estudo historiográfico que analisou fontes históricas posicionais indiretas e quantitativas seriadas e não seriadas. Resultados. As funções das amas de leite durante o período do estudo eram fornecer cuidados básicos e instrução cultural; A mortalidade dos enjeitados oscilou ao longo do período analisado. A distribuição por freguesias (unidade funcional das áreas de saúde da época) foi semelhante nestes anos, com predominância das províncias da Corunha e Pontevedra. Na expedição filantrópica contra a varíola participaram um total de 5 crianças galegas da Casa analisada, os seus nomes eram: Juan Antônio, Jacinto, Gerônimo María, Francisco Florencio e Juan Francisco. Conclusão. Durante o período de observação, as nutrizes do Hospital Real de Santiago de Compostela prestaram cuidados pediátricos. As amas de leite desempenharam um papel fundamental na manutenção da vida dos enjeitados e podem ser consideradas uma das figuras precursoras da profissão de enfermagem pediátrica da época.

As vacinas contra a covid-19 em plataformas de vídeos curtos no Brasil: o caso do Kwai / Covid-19 vaccines on short video platforms in Brazil: the case of Kwai / Las vacunas contra la covid-19 en plataformas de videos cortos en Brasil: el caso del Kwai

Neste artigo, analisamos as temáticas, os posicionamentos, as formas expressivas, os atores legitimados e os recursos visuais e sonoros empregados na produção de 482 vídeos sobre vacinas, publicados de 2020 a 2022 na plataforma de vídeos curtos Kwai. A partir de análise temática e de análise de conteúdo, identificamos que os vídeos apresentaram, em sua maioria, posicionamento favorável ou neutro em relação às vacinas e que ressaltaram as experiências pessoais com a vacinação. Não obstante, utilizaram sobretudo um tom hu-morístico no tratamento do assunto, com potencial desinformativo quanto aos efeitos colaterais das vacinas. Concluímos assim que, por um lado, o Kwai tem sido utilizado para expressão de experiências positivas com a vacinação, que podem estimular a adesão aos imunizantes, mas, por outro, tem sido também espaço para a circulação de percepções negativas e temores que podem suscitar dúvidas quanto à segurança das vacinas.

In this article, we analyze the themes, positions, expressive forms, legitimized actors, and both visual and sound resources used in the production of 482 videos about vaccines, published from 2020 to 2022 on the short video platform Kwai. Based on thematic analysis and content analysis, we identified that the videos predominantly presented a favorable or neutral stance toward vaccines and that they highlighted personal experiences with immunization. However, they mainly used a humorous tone when dealing with the subject, thereby potentially disseminating misinformation regarding the adverse effects of vaccines. We thus conclude that, on the one hand, Kwai has been used to express positive experiences with vaccination, which can stimulate adherence to vaccinations, but, on the other hand, it has also been a space for the circulation of negative perceptions and fears that can raise doubts regarding the safety of vaccines.

En este artículo, analizamos los temas, posiciones, formas expresivas, actores legitimados y recursos visuales y sonoros utilizados en la producción de 482 videos sobre vacunas publicados de 2020 a 2022 en la plataforma de videos cortos Kwai. A partir del análisis temático y de contenido, identificamos que los videos presentaban, en su mayoría, una posición favorable o neutral con relación a las vacunas y que destacaban experiencias per-sonales con la vacunación. Sin embargo, al abordar el tema, utilizaron, principalmente, un tono humorístico, con potencial desinformativo sobre los efectos secundarios de las vacunas. De ese modo, concluimos que, por un lado, el Kwai tiene sido utilizado para expresar experiencias positivas con la vacunación que pueden estimular la adhesión a las vacunas, pero, por otro lado, también tiene sido un espacio para la circulación de percepciones negativas y miedos que pueden plantear dudas sobre la seguridad de las vacunas.

Antibody persistence 7 years after hepatitis-A vaccine in children with human immunodeficiency virus infection / Persistencia de anticuerpos siete años después de la vacuna de la hepatitis A en niños con infección por el virus de la inmunodeficiencia humana

Abstract Background: HIV-infected children have a higher risk of presenting infections, including the hepatitis A virus (HAV). The inactivated HAV vaccine is immunogenic in immunocompetent hosts; however, there are insufficient studies on the duration of seroprotection in HIV-infected children. Methods: An analytical cohort study was conducted. HIV-1-infected children who received the inactivated HAV vaccine (2 doses) were included. Blood samples were taken for antibody measurement, the first one 28 days after the second dose and another 7 years after the vaccination schedule. Information on viral load, immunological category, weight, height, and response to antiretroviral treatment from diagnosis to the last assessment was obtained. Results: 19 patients were included, with a mean age of 12.6 years (SD ± 2.29). 58% were male. 80% of the patients presented protective immunoglobulin G antibodies against HAV 7-year post-vaccination. The antibody concentration was found to be between 13 and 80 mIU/mL (median of 80 mIU/mL). 52% showed some degree of immunosuppression. There was no statistically significant relationship between the presence of seroprotection and viral load, treatment failure, immunological category, and malnutrition. Twelve patients presented with antiretroviral treatment failure, and in 33% of them, the antibodies did not offer satisfactory seroprotection. Conclusion: 7-year post-vaccination, 80% of HIV-infected children maintain seroprotection titers against HAV.

Resumen Introducción: Los niños infectados por el virus de la inmunodeficiencia humana (VIH) tienen mayor riesgo de presentar infecciones, incluyendo hepatitis por virus A (VHA). La vacuna inactivada contra el VHA es inmunógena en el huésped inmunocompetente. No hay estudios suficientes sobre el tiempo de seroprotección en niños infectados por el VIH. Método: Estudio de cohorte, analítico. Se incluyeron niños con infección por VIH-1 que recibieron la vacuna inactivada contra el VHA (dos dosis). Se les tomaron muestras sanguíneas para medición de anticuerpos, una 28 días después de la segunda dosis y otra 7 años después del esquema de vacunación. Se obtuvo información de carga viral, categoría inmunológica, peso y talla, y respuesta al tratamiento antirretroviral desde el diagnóstico hasta la última valoración. Resultados: Se incluyeron 19 pacientes con una edad media de 12.6 años (± 2.29). El 58% fueron del sexo masculino. El 80% de los pacientes presentaron anticuerpos immunoglobulin G (IgG) contra el VHA protectores a los 7 años de la vacunación. La concentración de anticuerpos se encontró entre 13 y 80 mUI/ml (mediana: 80 mUI/ml). El 52% mostraron algún grado de inmunosupresión. No existe relación estadísticamente significativa entre la presencia de seroprotección y la carga viral, la falla al tratamiento, la categoría inmunológica ni la desnutrición. Doce pacientes presentaron falla al tratamiento antirretroviral; en el 33% de ellos los anticuerpos no ofrecían seroprotección satisfactoria. Conclusiones: A 7 años posvacunación, el 80% de los niños con VIH mantienen títulos de seroprotección frente al VHA.

Estruturação do plano de imunização no combate a covid-19: (des)ordem nos acordos entre os poderes / Structuring the immunization plan to fight covid-19: (dis)order in agreements between the powers / Estructura del plan de inmunización para combatir el covid-19: (des)orden en acuerdos entre potencias

Objetivo: Fomentar o debate acerca da ordenação do plano de vacinação nacional, considerando os aspectos organizacionais entre união, estados e municípios. Métodos: Revisão de literatura, tendo como base os periódicos Cientific Electronic Library Online (SCIELO), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) e Biblioteca Virtual de Saúde (BVS), usando como descritores: Pandemia, Vacina e Plano de Imunização. Com essa busca foram encontradas, inicialmente, 48 publicações. Após a realização da análise, foram incluídos 11 artigos científicos na revisão. Os textos foram submetidos à análise de conteúdo semântica. Resultados: Foram levantadas duas categorias: estratégias de combate a pandemia do covid-19 no Brasil, e a manipulação da sociedade civil e a desordem da cobertura vacinal. Conclusão: as reflexões aqui apresentadas podem contribuir para que os profissionais de enfermagem desenvolvam uma postura reflexiva frente a demanda vacinal, processo de planejamento e percepções da sociedade civil, podendo desencadear uma melhora na preparação para a educação em saúde. (AU)

Objective: To encourage the debate about the ordering of the national vaccination plan, considering the organizational aspects between the union, states and municipalities. Methods: Literature review, based on scientific journals Electronic Library Online (SCIELO), Coordination for the Improvement of Higher Education Personnel (CAPES) and Virtual Health Library (VHL), using as descriptors: Pandemia, Vaccine and Immunization Plan. With this search, 48 publications were initially found. After the analysis, 11 scientific articles were included in the review. The texts were subjected to semantic content analysis. Results: Two categories were raised: strategies to combat the covid-19 pandemic in Brazil, and the manipulation of civil society and the disorder of vaccination coverage. Conclusion: The reflections presented here can contribute for nursing professionals to develop a reflexive posture in face of the vaccine demand, planning process and civil society perceptions, which can trigger an improvement in the preparation for health education. (AU)

Objetivo: Fomentar el debate sobre la ordenación del plan nacional de vacunación, considerando los aspectos organizativos entre sindicato, estados y municipios. Métodos: Revisión de la literatura, con base en revistas científicas Biblioteca Electrónica en Línea (SCIELO), Coordinación para el Perfeccionamiento del Personal de Educación Superior (CAPES) y Biblioteca Virtual en Salud (BVS), utilizando como descriptores: Pandemia, Vacuna y Plan de Inmunización. Con esta búsqueda se encontraron inicialmente 48 publicaciones. Después del análisis, se incluyeron 11 artículos científicos en la revisión. Los textos fueron sometidos a análisis de contenido semántico. Resultados: Se plantearon dos categorías: estrategias para combatir la pandemia de covid-19 en Brasil y la manipulación de la sociedad civil y el desorden de la cobertura de vacunación. Conclusión: Las reflexiones aquí presentadas pueden contribuir para que los profesionales de enfermería desarrollen una postura reflexiva ante la demanda de vacunas, el proceso de planificación y las percepciones de la sociedad civil, lo que puede desencadenar una mejora en la preparación para la educación en salud. (AU)

Adherencia de adultos de la compañía Chauria para la vacunación contra la COVID-19

Introducción: La pandemia del COVID-19 ha provocado cambios que afectan a los sistemas sanitarios y al enfoque de las enfermedades infecciosas en todo el mundo. La demanda de vacunas contra el COVID-19 se encuadra en un espectro que va desde el rechazo hasta la demanda, con una aceptación pasiva en el medio. Objetivo: Determinar la adherencia de los adultos a la vacunación contra la COVID-19. Chauria-Caballero, Paraguay 2022. Metodología: Estudio observacional, descriptivo, de corte transversal, con enfoque cuantitativo. El muestreo fue no probabilístico por conveniencia. La muestra estuvo conformada por un total de 225 adultos; los datos fueron recabados por medio de una encuesta elaborada por la investigadora, los datos fueron procesados con el software EPI INFO. Resultados: La mayoría de los sujetos de estudio se vacunaron, y hubo adherencia de la población a la vacuna contra la COVID-19 en un 93 %; diversos factores influyeron en las decisiones de estos; el porcentaje de adultos no vacunados mencionan como motivos su desconfianza (69 %) y el miedo/temor a la vacunación (31 %). Discusión: El estudio encontró una alta adherencia en general, la gran mayoría de los participantes vacunados contra COVID-19, porcentajes significativos se reportaron en Chile, China y Catar, cifras muy altas con relación a la aceptación de la vacuna a nivel país, teniendo una cobertura con un porcentaje mayor a la mitad con al menos una dosis.

Introduction: The coronavirus disease (COVID-19) pandemic has caused changes that affect health systems and the approach to infectious diseases worldwide. The demand for COVID-19 vaccines falls on a spectrum from rejection to demand, with passive acceptance in between. Objective: To determine the adherence of adults to vaccination against COVID-19. Chauria-Caballero, Paraguay 2022. Methods: This was an observational, descriptive, cross-sectional study using a quantitative approach. For convenience, the sampling was non-probabilistic. The sample comprised of 225 adults. The data were collected through a survey elaborated by the researcher, and the data were processed using EPI INFO software. Results: The majority of the study subjects were vaccinated, and there was 93% adherence of the population to the COVID-19 vaccine. Various factors influenced their decisions; the percentage of unvaccinated adults mentioned their distrust (69%) and fear of vaccination (31%). Discussion: The study found high adherence in general, the vast majority of participants were vaccinated against COVID-19, with significant percentages reported in Chile, China, and Qatar, very high figures in relation to the acceptance of the vaccine at the country level, with coverage of more than half with at least one dose.

Dengue en paciente de 32 días de vida. Reporte de un caso poco habitual / Dengue fever in a 32-day-old patient. A rare case report

El dengue es una enfermedad viral transmitida por la picadura del mosquito Aedes aegypti. El comportamiento del dengue en Argentina es epidémico; la mayoría de los casos se observan en los meses de mayor temperatura. Hasta la semana epidemiológica (SE) 20/2023, se registraron en Argentina 106 672 casos; se vieron afectadas 18 de las 24 provincias que conforman el país. Dentro de los principales grupos de riesgo, se incluyen los menores de 2 años. Reconocer los signos, síntomas e identificar los factores de riesgo es fundamental para el manejo de casos con mayor riesgo de gravedad. Presentamos el caso de una paciente de 32 días de vida que se internó por síndrome febril sin foco, con diagnósticos diferenciales de meningitis viral y sepsis, evolucionó con leucocitosis, plaquetopenia, hipoalbuminemia, asociado a exantema y edemas. Se llegó al diagnóstico de dengue por la clínica, epidemiologia e IgM positiva.

Dengue fever is a viral disease transmitted by the Aedes aegypti mosquitoes. In Argentina, dengue fever is an epidemic disease; most cases are reported during the hot months.Until epidemiological week (EW) 20/2023, 106 672 cases were reported across 18 of the 24 provinces of Argentina. Children younger than 2 years are among the main groups at risk. Recognizing signs and symptoms and identifying risk factors is fundamental for the management of cases at a higher risk of severity. Here we describe the case of a 32-day-old female patient who was hospitalized due to febrile syndrome without a source, who had a differential diagnosis of viral meningitis and sepsis and progressed to leukocytosis, thrombocytopenia, hypoalbuminemia in association with rash and edema. The diagnosis of dengue fever was established based on clinical, epidemiological, and positive IgM data.

Vacinas passado e futuro ­ Reflexões para discussão / The past and future of vaccines ­ Reflections for discussion

Neste artigo de opinião, apresento uma breve história do desenvolvimento de vacinas, comentando sobre as formas clássicas de produção de vacinas utilizando o próprio agente infeccioso. Em seguida, abordo as vacinas virais, discutindo seus benefícios e dificuldades e a questão dos sorotipos virais, bem como as vacinas bacterianas e seu relativo sucesso. Apresento nossos estudos sobre doença cardíaca reumática e o desenvolvimento de uma vacina contra infecções estreptocócicas. Também discuto plataformas vacinais, especialmente os sucessos alcançados com vacinas de vetores virais não replicantes e, acima de tudo, o grande êxito das vacinas de RNA mensageiro (mRNA). As vacinas de mRNA tornaram-se possíveis somente após os avanços obtidos com a substituição de nucleotídeos que reduziam a ação da imunidade inata. Serão todas as vacinas desenvolvidas a partir de mRNA no futuro? Em seguida, abordo a questão das vias de administração de vacinas, seja por via subcutânea, intradérmica, intramuscular ou nasal. Exponho dados do meu laboratório sobre o desenvolvimento de uma vacina de instilação nasal que induziu uma resposta de proteção da mucosa, prevenindo a infecção e, consequentemente, a transmissão do SARS-CoV-2. Posteriormente, discuto quais vacinas futuras poderiam ser desenvolvidas para além das doenças infecciosas agudas. Por fim, discuto as vantagens do desenvolvimento de vacinas seguras, eficazes e de uso múltiplo, bem como a forma de torná-las acessíveis à população mundial, promovendo a equidade em saúde.

In this opinion article, I provide a brief history of vaccine development, commenting on the classic ways of producing vaccines using the infectious agent itself. I address viral vaccines, discussing their benefits and challenges and the issue of viral serotypes, as well as bacterial vaccines and their relative success. I present our studies on rheumatic heart disease and the development of a vaccine against streptococcal infection. I also discuss vaccine platforms, highlighting the success achieved with non-replicating viral vector-based vaccines and, especially, with messenger RNA (mRNA) vaccines. mRNA vaccines only became possible after the advances provided by the replacement of nucleotides that reduced the action of the innate immune system. Will all vaccines be made from mRNA in the future? Then, I address the issue of vaccine administration routes, whether subcutaneously, intradermally, intramuscularly, or intranasal. I present data from my laboratory on the development of an intranasal vaccine that induced a protective mucosal response, preventing infection and, consequently, the transmission of SARSCoV- 2. I discuss which future vaccines could be developed beyond acute infectious diseases. Finally, I discuss the advantages of developing safe, effective, multiple-use vaccines and how to make them accessible worldwide by promoting health equity.

Production of dendritic cell vaccines using different methods with equivalent results: Implications for emerging centers

Introduction Dendritic cell (DC) vaccines have demonstrated good efficacy in preventing relapse and in increasing survival of patients affected by a variety of both solid and hematological tumors. Most protocols used to generate these cells involve the automated separation of peripheral blood monocytes from patients. This approach requires specialized equipment, which elevates the cost of this type of therapy, potentially limiting the widespread access to patients. Method: In this study, we compare the yield and quality of dendritic cells generated from monocytes and isolated by an automated method or by manual methods using gradient centrifugation. Results The results demonstrate the equivalence of the 3 methods in relation to the yield and final quality of the product, however with considerable differences between the costs of these procedures. In addition, this study also demonstrates the feasibility of the antigenic pulse with autologous tumor cell lysates, constituting a source of antigens, not only easily obtained and manipulated, but also specific to the patient's tumor. Conclusion These findings may have important implications for emerging centers interested in using this medical approach and potentially increase the access of a greater number of patients to this therapeutic option.

Trichostatin A-modified vaccine provides superior protection against ovarian cancer formation and development

More attention has been paid to immunotherapy for ovarian cancer and the development of tumor vaccines. We developed a trichostatin A (TSA)-modified tumor vaccine with potent immunomodulating activities that can inhibit the growth of ovarian cancer in rats and stimulate immune cell response in vivo. TSA-treated Nutu-19 cells inactivated by X-ray radiation were used as a tumor vaccine in rat ovarian cancer models. Prophylactic and therapeutic experiments were performed with TSA-modified tumor vaccine in rats. Flow cytometry and ELISpot assays were conducted to assess immune response. Immune cell expression in the spleen and thymus were detected by immunohistochemical staining. GM-CSF, IL-7, IL-17, LIF, LIX, KC, MCP-1, MIP-2, M-CSF, IP-10/CXCL10, MIG/CXCL9, RANTES, IL-4, IFN-γ, and VEGF expressions were detected with Milliplex Map Magnetic Bead Panel immunoassay. TSA vaccination in therapeutic and prophylactic models could effectively stimulate innate immunity and boost the adaptive humoral and cell-mediated immune responses to inhibit the growth and tumorigenesis of ovarian cancer. This vaccine stimulated the thymus into reactivating status and enhanced infiltrating lymphocytes in tumor-bearing rats. The expression of key immunoregulatory factors were upregulated in the vaccine group. The intensities of infiltrating CD4+ and CD8+ T cells and NK cells were significantly increased in the vaccine group compared to the control group (P<0.05). This protection was mainly dependent on the IFN-γ pathway and, to a much lesser extent, by the IL-4 pathway. The tumor cells only irradiated by X-ray as the control group still showed a slight immune effect, indicating that irradiated cells may also cause certain immune antigen exposure, but the efficacy was not as significant as that of the TSA-modified tumor vaccine. Our study revealed the potential application of the TSA-modified tumor vaccine as a novel tumor vaccine against tumor refractoriness and growth. These findings offer a better understanding of the immunomodulatory effects of the vaccine against latent tumorigenesis and progression. This tumor vaccine therapy may increase antigen exposure, synergistically activate the immune system, and ultimately improve remission rates. A vaccine strategy designed to induce effective tumor immune response is being considered for cancer immunotherapy.

Research progress on diabetes and human papilloma virus infection and vaccination / 公共卫生与预防医学

Diabetes is a common chronic non-infectious disease. Diabetic patients not only suffer from metabolic disorders, but are also prone to immune deficiencies and are at a higher risk of being infected with human papillomavirus (HPV). Many studies at home and abroad have shown that the HPV infection rate of patients with diabetes is higher than that of non-diabetic patients. Patients with diabetes can benefit from HPV vaccination, and the tolerance is good. HPV vaccination is recommended for diabetic patients. This article reviews the research on diabetes, HPV infection, and HPV vaccine, which will provide references for HPV vaccination in diabetic patients.

Trend analysis of hemagglutinin and ovalbumin content for influenza virus split vaccines in 2021 / 中国生物制品学杂志

@#Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated. The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established. The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise. Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable. The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1. 094 and 0. 742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0. 05),the HA contents of H1N1(t = 3. 862,w = 232),H3N2(t = 8. 225 and3. 473 respectively)and By(t = 5. 616 and 4. 934 respectively)of the two enterprises had significant differences(P <0. 05). The results of enterprises were generally higher than the lot release institution. Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good. The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.

Development and verification of a high performance liquid chromatography method for determination of aluminium adjuvant content in vaccine / 中国生物制品学杂志

@#Objective To develop a high performance liquid chromatography(HPLC)method for determination of aluminium adjuvant content in vaccine,and verify and preliminarily apply the method.Methods The 8-hydroxyquinoline derivatization method was used for determination. The chromatographic column was phenyl-hexyl column[Luna 5u PhenylHexyl(250 mm × 4. 6 mm)],and the mobile phase was composed of ammonium acetate solution-acetonitrile(with 8-hydroxyquinoline)(60 ∶ 40)containing 20 mg/L ascorbic acid,while eluted at a flow rate of 1. 0 mL/min with the isocratic eluent. The excitation wavelength and the emission wavelength of the fluorescence detector were 380 nm and 520 nm respectively. The column temperature was 40 ℃,and the sample injection was 50 μL. The developed method was verified for the specificity,linear range,accuracy,repeatability,stability and durability,and used to determine the aluminum content in 12 batches of vaccines. The results were compared with those determined by titration in general principle 3106of Chinese Pharmacopoeia(VolumeⅢ,2020 edition).Results No interference peaks appeared in the sample chromatogram,and the non-aluminum adjuvant vaccine components and phosphate buffer had no interference with the determination. The linearity of aluminum standard was good in the concentration range of 6. 25 ～ 100 μg/mL,r = 0. 999 6. The average results of spike recoveries of aluminum content in inactivated hepatitis A vaccine,recombinant hepatitis B vaccine,adsorbed acellular DTP vaccine and inactivated enterovirus 71 vaccine were 98. 32%,100. 85%,101. 09% and 99. 31%,respectively in the verification for accuracy. The relative standard deviations(RSDs) of the determination results of aluminum content in the solution of six samples of the four vaccines in the same batch were 1. 09%,1. 42%,0. 97% and1. 30%,respectively. The RSDs of aluminum content of four vaccine samples stored at room tempe-rature for 0,2,4,6 and8 h were 0. 82%,0. 73%,0. 40% and 0. 48%,respectively. When the ratio of ammonium acetate solution to 8-hydroxyquinoline acetonitrile solution in mobile phase changed within 5%,the fluctuation range of aluminum content of four vaccines was less than 2%. There was no significant difference between the developed HPLC method and the titration method of Chinese Pharmacopoeia(VolumeⅢ,2020 edition)for determination of aluminum content in the 12 batches of vaccine samples.Conclusion A HPLC method for determination of aluminum adjuvant content in vaccines has been successfully established with good specificity,linearity,accuracy,repeatability,stability and durability,simple operation,high degree of automation and less interference of manual factors. It can realize the determination of aluminium content in single dose,which provides an effective means for the rapid and large-scale determination of aluminum content in vaccine products and monitoring the dispensing of semi-final products in the production process.

Progress in research on novel BC adjuvant system / 中国生物制品学杂志

@#Vaccines with novel adjuvants have been listed abroad,while in China,except for aluminum adjuvants widely used in vaccine research and production,few other novel adjuvants have been successfully listed. This paper briefly summarized the source,development history,research progress on biological activity and immune mechanism as well as safety evaluation of the novel BC adjuvant system with independent intellectual property right which has been applied to the vaccine in clinical research stage,so as to provide theoretical support for selection of the adjuvant in the development of novel vaccine.

Efficacy, effectiveness, and safety of COVID-19 vaccine compared to placebo in preventing COVID-19 infection among 12-17 years old: A systematic review

Objectives@#The World Health Organization recently revised their recommendations and considered healthy children and adolescents as low priority group for COVID-19 vaccine. This review comprehensively assessed existing clinical evidence on COVID-19 vaccine in 12-17 years old.@*Methods@#Included in this review were any type of study that investigated the efficacy, immunogenicity, safety, and effectiveness of COVID-19 vaccine on protection against SARS-COV-2 infection in 12-17 years old. Various electronic databases were searched up to March 15, 2023. Studies were screened, data extracted, risk of bias appraised, and certainty of evidence was judged using GRADE. Review Manager 5.4 was used to estimate pooled effects. Difference between the two groups was described as mean difference for continuous variables and as relative risk or odds ratio for categorical variables.@*Results@#There were six randomized controlled trials and 16 effectiveness studies (8 cohorts and 8 case control). Low certainty evidence showed that BNT162b2 (Pfizer) was effective, immunogenic, and safe in healthy adolescents. There were 15 effectiveness studies on BNT162b2 (Pfizer) in healthy adolescent and one on immunocompromised patients. It was protective against infection with any of the variants, with higher protection against Delta than Omicron. BNT162b2 is protective against hospitalization and emergency and urgent care (high certainty); and critical care and MIS-C (low). Very low certainty evidence noted that BNT 162b2 was also immunogenic in 12-21 years old with rheumatic diseases while on immunomodulatory treatment but with possible increased exacerbation of illness. Low certainty evidence demonstrated that mRNA-1273 (Moderna) was effective, immunogenic, and safe. Low to very low certainty evidence were noted on the safety and immunogenicity of two vector base vaccines (ChAdOx1-19 and Ad5 vector COVID vaccine) and two inactivated vaccines (CoronaVac and BBIBP CorV).@*Conclusion@#There is presently low certainty evidence on the use of RNA vaccines in 12-17 years old. The recommendation on its use is weak. There is presently insufficient evidence for the use of inactivated and vector-based COVID-19 vaccines. Different countries should consider whether to vaccinate healthy adolescent without comprising the other recommended immunization and health priorities that are crucial for this age group. Other factors including cost-effectiveness of vaccination and disease burden should be accounted.

Research status and vaccination policy of human papillomavirus vaccine / 上海预防医学

Cervical cancer is a common gynecological malignant tumor. Vaccination with human papilloma virus （HPV） vaccine is of great significance to prevent condyloma acuminatum， HPV infection， and cervical cancer. This paper reviews the epidemic situation and risk factors of cervical cancer， the prevention strategies of cervical cancer， HPV types， HPV vaccine types and mechanisms of action， the safety and effectiveness of vaccines， men’s HPV vaccination， vaccination policies in various countries and so on， and further puts forward suggestions on HPV vaccination policies in China.

Preparation and immunization effect evaluation of recombinant F protein vaccine of respiratory syncytial virus / 中国生物制品学杂志

@#Objective To prepare recombinant F protein vaccine of respiratory syncytial virus(RSV) and evaluate its immunization effect.Methods Two RSV vaccines based on RSV F protein were prepared:one was a mucosal vaccine with bacterial like particle(BLP)as adjuvant and the other was an injectable vaccine with aluminium hydroxide as adjuvant.Forty female BALB/c mice were randomly divided into four groups:BLP-F,BLP control,AL-F and AL control group,with 10mice in each group.BLP-F and BLP control group were inoculated intranasally,and AL-F and AL control group were inoculated subcutaneously.The mice were immunized once each at day 0,14 and 28,respectively.Two weeks after the last immunization,the titers of serum IgG antibody and IgA antibody in nasal lotion were detected by ELISA,and the titers of neutralizing antibody were detected by plaque test.Results Both vaccines induced high levels of serum binding antibodies and neutralizing antibodies,and the induction capacity of injected vaccine was stronger than that of mucosal vaccine.The injected vaccine induced the increase of IgG in serum,which was about 10 times higher than the mucosal immune response,but could not induce the increase of IgA.However,the mucosal vaccine induced the high level of mucosal IgA,but the serum IgG antibody was relatively low.Conclusion Both vaccines based on RSV F protein are promising candidates,and each vaccine has its own advantages.Follow-up studies will evaluate the feasibility of these two vaccines as immunogens using a combination immunization approach to simultaneously enhance systemic and mucosal immune responses against RSV.

Establishment and validation of a universal test method in vitro for SARS-CoV-2 mRNA vaccine potency / 中国生物制品学杂志

@#Objective To establish and verify a universal and stable potency test method in vitro for SARS-CoV-2 mRNA vaccine,so as to use it for the quality control of SARS-CoV-2 mRNA vaccine.Methods ELISA kits that could bind well to S protein of SARS-CoV-2 variants,as well as transfected cells,cell plating concentrations and doses for transfection were screened,and then a potency test method for SARS-CoV-2 mRNA vaccine in vitro was established and verified.Results An ELISA kit was found with good binding ability to S protein of each variant,and HEK293T cells were determined as the transfection cells,with the plating concentration of 2.5 × 10~5 cells/mL and the transfection dose of 4 μg/well in the 6-well plate.An universal and stable potency test method for SARS-CoV-2 mRNA vaccine in vitro was established.The verification results showed that the method met the quality control needs.Conclusion The established potency test method in vitro for SARS-CoV-2 mRNA vaccine has good relative accuracy,linearity,intermediate precision and range,and can be applied to the quality control of SARS-CoV-2 mRNA vaccines

Advances in meningococcal polysaccharide conjugate vaccine research / 中国生物制品学杂志

@#Meningococcal polysaccharide conjugate vaccine is basically produced by chemical combination,and the most commonly used method is amide condensation reaction.Because of the covalent bonds between polysaccharide and protein,the prepared conjugate vaccine has high stability and good technical advantages,which plays an important role in the prevention of meningococcal related diseases.The vaccine can be applied to the immunization of young children under 2years old,and has more lasting protective effect.In this paper,the factors influencing the preparation of meningococcal polysaccharide conjugate vaccine,the binding mode of polysaccharide and carrier protein,the present situation at home and abroad and the existing problems in the preparation process were reviewed.

Safety study of 23-valent pneumococcal polysaccharide vaccine in Hebei Province / 公共卫生与预防医学

Objective To analyze the occurrence characteristics of adverse events following immunization (AEFI) of 23-valent pneumococcal polysaccharide vaccine (PPSV-23) in Hebei Province and to evaluate the safety of the vaccine. Methods AEFI cases related to vaccination of PPSV-23 in Hebei Province from January 1, 2020 to December 31, 2022 were collected through the AEFI surveillance module of Chinese Center for Disease Control and Prevention Information System. The incidence of reported AEFI cases were then analyzed and compared. Results The reported incidence rate of AEFI of PPSV-23 was 56.12 /100,000 doses, and the incidence rate of adverse reactions was 55.50 /100 000 doses. The incidence rate of common adverse reactions was 53.94/100 000 doses, and the incidence rate of rare adverse reactions was 1.56/100 000 doses. Most of the reported AEFI cases caused by PPSV-23 were common adverse reactions, which occurred mainly within one day after vaccination, and the overall regression was positive. Conclusion The 23-valent pneumococcal polysaccharide vaccine used in Hebei Province is safe，but its safety monitoring still needs to be strengthened.

Current status of HPV vaccine uses among adolescents in China / 公共卫生与预防医学

Combining domestic and international studies, an overview of the development of human papilloma virus (HPV) vaccine in the world and China is presented. The current situation of HPV vaccination for adolescents in China is analysed in the light of the latest policies in China, and rationalized recommendations are made to improve the HPV vaccination rate for adolescents in China.