RESUMO
Despite having emerged from pandemic status, the incidence of COVID-19 episodes has recently increased in Spain, including pediatric cases and admissions to Intensive Care Units. Several recombinant variants are circulating among us, particularly XBB arising from two Omicron BA.2 sublineages with mutations in the genes encoding the spicule proteins that could increase binding to the ACE2 receptor and be more prone to immune escape. Faced with these, 3 pharmaceutical companies have developed vaccines adapted to the XBB.1.5 sublineage that are already available for administration in our setting with risks that should not be different from those of previous mRNA vaccines and with clearly favorable benefit/risk ratios. They should be applied to patients with potential for poor COVID-19 evolution and to collectives that have a particular relationship of proximity with them. Their application should be understood not only from a perspective of individual convenience but also from that of collective responsibility. The most convenient seems to be a simultaneous immunization of COVID-19 and influenza in our environment. In the therapeutic aspect, there is little to expect right now from antisera, but the already known antiviral drugs are still available and indicated, although their efficacy will have to be reevaluated due to their impact on populations that are mostly immunized and with a better prognosis than in the past. In our opinion, it is necessary to continue to make a reasonable and timely use of masks and other non-pharmacological means of protection. (AU)
Pese a haber salido de la situación de pandemia, la incidencia de episodios de COVID-19 ha aumentado recientemente en España, incluidos los casos pediátricos y los ingresos en Unidades de Cuidados Intensivos. Circulan entre nosotros diversas variantes recombinantes, particularmente la XBB surgidas de dos sublinajes Omicron BA.2 con mutaciones en los genes que codifican las proteínas de la espícula y que pudieran aumentar la unión al receptor ACE2 y ser más propensas al escape inmune. Frente a ellas, 3 empresas farmacéuticas han elaborado vacunas adaptadas al sublinaje XBB.1.5 que ya se encuentran disponibles para su administración en nuestro medio con riesgos que no deben ser diferentes a los de las vacunas mRNA previas y con relaciones beneficio/riesgos claramente favorables. Deben aplicarse a pacientes con potencial de mala evolución de COVID-19 y a los colectivos que tienen una particular relación de proximidad con ellos. Su aplicación debe ser entendida no sólo desde una perspectiva de conveniencia individual sino desde la de la responsabilidad colectiva. Lo más conveniente parece hacer una inmunización simultánea de COVID-19 y gripe en nuestro medio. En el aspecto terapéutico hay poco que esperar ahora mismo de los antisueros pero siguen estando disponibles e indicados los fármacos antivirales ya conocidos aunque su eficacia tendrá que reevaluarse por su impacto en poblaciones mayoritariamente inmunizadas y con pronóstico mejor que las de tiempos pasados. A nuestro juicio, es necesario seguir haciendo un uso razonable y puntual de mascarillas y otros medios no farmacológicos de protección. (AU)
Assuntos
Humanos , /prevenção & controle , /terapia , /instrumentação , /métodos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/uso terapêutico , Influenza Humana/prevenção & controle , Máscaras , Vacinas/administração & dosagem , Vacinas/provisão & distribuição , Vacinas/uso terapêutico , RitonavirRESUMO
The number of people with immunosuppression is increasing considerably due to their greater survival and the use of new immunosuppressive treatments for various chronic diseases. This is a heterogeneous group of patients in whom vaccination as a preventive measure is one of the basic pillars of their wellbeing, given their increased risk of contracting infections. This consensus, developed jointly by the Sociedad Española de Infectología Pediátrica (Spanish Society of Pediatric Infectious Diseases) and the Advisory Committee on Vaccines of the Asociación Española de Pediatría (Spanish Association of Paediatrics), provides guidelines for the development of a personalised vaccination schedule for patients in special situations, including general recommendations and specific recommendations for vaccination of bone marrow and solid organ transplant recipients, children with inborn errors of immunity, oncologic patients, patients with chronic or systemic diseases and immunosuppressed travellers.
Assuntos
Hospedeiro Imunocomprometido , Vacinação , Vacinas , Humanos , Comitês Consultivos , Doenças Transmissíveis , Consenso , Vacinação/normas , Vacinas/administração & dosagemRESUMO
Objective: To understand the incidence of delayed vaccination with the national immunization program vaccines among children aged 0-6 years in Xuhui District, Shanghai, and to evaluate the safety of delayed vaccination. Methods: A stratified random sampling was used to obtain six vaccination clinics in Xuhui District, Shanghai. The vaccination records of children 0-6 years from these six vaccination clinics were collected from the Shanghai Immunization Program Information Management System. Adverse events following immunization (AEFI) data were collected from the China Information System for Disease Control and Prevention. Descriptive epidemiology was used to analyze the data. Children were divided into the timely vaccination group and delayed vaccination group according whether they were delayed in vaccination (received one month or more after the recommended age among children aged ≤1 year; received three months or more after the recommended age among children aged >1 year). The safety of four vaccination methods-individual vaccination, simultaneous vaccination, routine vaccination and combined vaccination-were further compared. Differences between groups were compared using chi-square test. Results: From 2019 to 2021, six vaccination clinics in Xuhui District administered 124 031 doses of the national immunization program vaccines among children aged 0-6 years, and delayed vaccinations accounted for 25.99% (32 234/124 031) of these doses. In 2020, the delayed vaccination rate during the first-level COVID-19 public health emergency response period in Shanghai was significantly higher than that in the same period in 2019 (34.70% vs. 24.19%, χ2=136.23, P<0.05). The delayed vaccination rate during the COVID-19 vaccination campaign in 2021 was significantly higher than that in the same period in 2019 (25.27% vs. 22.55%, χ2=82.80, P<0.05). From 2019 to 2021, a total of 475 cases of AEFI were reported in six vaccination clinics, with a reported incidence of 382.97 per 100 000 doses, including 421 cases of common adverse reaction (88.63%, 339.43 per 100 000 doses), 51 cases of rare adverse reaction (10.74%, 41.12 per 100 000 doses) and 3 cases of coincidences (0.63%, 2.42 per 100 000 doses). The reported incidence of AEFI among delayed vaccinations was significantly lower than that among timely vaccinations (291.62 per 100 000 doses vs. 415.05 per 100 000 doses). The incidence of AEFI for the four delayed vaccination methods (individual vaccination, simultaneous vaccination, routine vaccination and combined vaccination) was lower than that for timely vaccination. There were significant differences between the groups except for the routine vaccination group (χ2=9.82, P<0.05; χ2=5.46, P<0.05; χ2=2.97, P>0.05; χ2=11.89, P<0.05). Conclusions: In Xuhui District of Shanghai, 25.99% of doses of the national immunization program vaccines administered to children 0-6 years were delayed. Delayed vaccination does not increase the risk of AEFI compared with timely vaccination.
Assuntos
Imunização , Vacinas , Criança , Humanos , Lactente , China/epidemiologia , COVID-19 , Vacinas contra COVID-19 , Programas de Imunização , Vacinação , Vacinas/administração & dosagemRESUMO
BACKGROUND: The immunization system in the Democratic Republic of the Congo faces many challenges, including persistent large-scale outbreaks of polio, measles, and yellow fever; a large number of unvaccinated children for all antigens; minimal and delayed funding; and poor use of immunization data at all levels. In response, the Expanded Programme on Immunization within the Ministry of Health (MOH) collaborated with global partners to develop a revitalization strategy for the routine immunization (RI) system called the Mashako Plan. MASHAKO PLAN DESIGN AND DEVELOPMENT: The Mashako Plan aimed to increase full immunization coverage in children aged 12-23 months by 15 percentage points overall in 9 of 26 provinces within 18 months of implementation. In 2018, we conducted a diagnostic review and identified gaps in coordination, service delivery, vaccine availability, real-time monitoring, and evaluation as key areas for intervention to improve the RI system. Five interventions were then implemented in the 9 identified provinces. DISCUSSION: According to the 2020 vaccine coverage survey, full immunization coverage increased to 56.4%, and Penta3/DTP3 increased to 71.1% across the Mashako Plan provinces; the initial objective of the plan was reached and additional improvements in key service delivery indicators had been achieved. Increases in immunization sessions held per month, national stock of pentavalent vaccine, and supervision visits conducted demonstrate that simple, measurable changes at all levels can quickly improve immunization systems. Despite short-term improvements in all indicators tracked, challenges remain in vaccine availability, regular funding of immunization activities, systematic provision of immunization services, and ensuring long-term sustainability. CONCLUSIONS: Strong commitment of MOH staff combined with partner involvement enabled the improvement of the entire system. A simple set of interventions and indicators focused the energy of managers on discrete actions to improve outcomes. Further exploration of the results is necessary to determine the long-term impact and generate all-level engagement for sustainable success in all provinces.
Assuntos
Programas de Imunização , Cobertura Vacinal , Vacinas , Humanos , Criança , República Democrática do Congo , Avaliação de Programas e Projetos de Saúde , Vacinas/administração & dosagemRESUMO
Various therapeutic options are available for verruca. While physical destruction may be associated with scarring, immunotherapy may be effective in treating warts through stimulating body immune response. The objective of the study was to compare the efficacy, safety, and outcome of Candida antigen vs diphencyprone (DPCP) in the treatment of warts. Fifty patients were randomly assigned to receive either intralesional Candida antigen every 3 weeks or weekly DPCP application. Both treatments were applied only to the mother wart. Lesions' clearance and associated side effects were observed up to 4 weeks after treatment. Two blinded physicians evaluated photos of warts before and 4 weeks after the end of treatment. Both modalities granted wart clearance and/or improvement with no statistically significant difference; however, Candida antigen was significantly better in clearing adjacent untreated warts (p = 0.046). Fewer side effects were observed among the Candida antigen group. The response was duration associated in the Candida groups only. Intralesional Candida antigen injection and DPCP treatments for warts yielded improvement with superiority of Candida injection in eradicating distant lesions and fewer side effects. A shorter wart duration may be associated with a better therapeutic response with Candida antigen.
Assuntos
Antígenos de Fungos , Candidíase , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacinas , Verrugas , Humanos , Antígenos de Fungos/administração & dosagem , Antígenos de Fungos/efeitos adversos , Candida , Imunoterapia/efeitos adversos , Injeções Intralesionais , Resultado do Tratamento , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Verrugas/terapia , Ciclopropanos/administração & dosagem , Ciclopropanos/efeitos adversos , Candidíase/terapiaRESUMO
The landscape of pediatric vaccination has changed dramatically due to changing attitudes toward immunizations and recent world events. The rise of vaccine hesitancy and refusal related to the concurrent rise of social media and anti-vaccination messages with misinformation campaigns have led to populations of children being unimmunized or under-immunized. These populations have been left vulnerable to the rapid spread of vaccine-preventable infection. Additionally, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the clinical syndrome known as coronavirus disease 2019 (COVID-19) resulted in the emergence of a worldwide pandemic. Control measures to mitigate the spread of COVID-19 resulted in numerous reports of children missing routine vaccines along with the stopping of many public health immunization programs. Finally, armed conflicts and war have led to large family migrations from their homelands to various countries and regions leading to increased risk for missed maternal and child immunization as well as difficulty in keeping vaccination records. [Pediatr Ann. 2022;51(11):e426-e430.].
Assuntos
Conflitos Armados , Hesitação Vacinal , Doenças Preveníveis por Vacina , Vacinas , Criança , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Pandemias/prevenção & controle , SARS-CoV-2 , Doenças Preveníveis por Vacina/epidemiologia , Doenças Preveníveis por Vacina/prevenção & controle , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Programas de Imunização , Desinformação , Emigração e Imigração , Mães , Recusa de VacinaçãoRESUMO
Introducción: La tosferina ha aumentado su incidencia y severidad especialmente en lactantes, por lo que la vacunación de la embarazada se ha introducido como estrategia preventiva. La pandemia de la COVID-19 parece haber disminuido la incidencia de distintas enfermedades respiratorias. Métodos: Estudio retrospectivo entre 2012-2021, analizando la influencia de la vacunación de la embarazada y del primer año de la pandemia de la COVID-19 en los casos de tosferina. Resultados: Se incluyeron 960 pacientes de atención primaria y hospitalaria con sospecha de tosferina, con 130 casos diagnosticados (104 niños y 26 adultos). En el periodo posvacunal, se observó una disminución de casos y de severidad de la tosferina en niños menores de 6 meses y de los diagnósticos en mujeres adultas. No se detectó ningún paciente con tosferina durante el periodo de la COVID-19. Conclusión: Tanto la vacunación de la embarazada como el primer año de la pandemia de la COVID-19 han disminuido significativamente los casos de tosferina.(AU)
Background: Whooping cough has had an increased incidence and severity specially in infants and maternal immunization has been implemented as a prevention strategy. COVID-19 pandemic seems to decrease the incidence of other respiratory diseases. Methods: Retrospective study from 2012 to 2021 to assess the influence of pertussis maternal immunizations and the first year of COVID-19 pandemic in the cases of whooping cough. Results: 960 suspected cases from primary care and hospital, with 130 cases (104 children and 26 adults) being diagnosed of whooping cough. In the post-vaccination period, a reduction in the cases and severity in infants up to 6 months old was observed as well as in the pertussis diagnosis in adult women. There were no whooping cough cases during the COVID-19 period. Conclusions: Both the pertussis vaccination in pregnancy and the first year of the COVID-19 pandemic have decreased the number of pertussis cases.(AU)
Assuntos
Humanos , Feminino , Gravidez , Pandemias , Betacoronavirus , Infecções por Coronavirus , Coronavírus Relacionado à Síndrome Respiratória Aguda Grave , Gestantes , Vacinação , Coqueluche , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Estudos Retrospectivos , Microbiologia , Doenças TransmissíveisAssuntos
Vacinação , Vacinas , Adolescente , Humanos , Vacinação/métodos , Vacinas/administração & dosagem , Vacinas/uso terapêuticoRESUMO
Transdermal drug delivery systems (TDDSs) overcome the hurdle of an intact skin barrier by penetrating the skin to allow molecules through. These systems reduce side effects associated with conventional hypodermic needles. Here, we introduce novel microneedle (MN) TDDSs that enhance drug delivery by creating micron-sized pores across the skin. Many MN TDDSs designed to deliver a diverse array of therapeutics, including allergen-specific immunotherapy, skin disease treatments, and vaccines, are under pre-clinical and clinical trials. Although epicutaneous approaches are emerging as new options for treating food allergy in many clinical trials, MN TDDSs could provide a more efficient and convenient route to deliver macromolecules. Furthermore, MN TDDSs may allow for safe vaccine delivery without permanent scars. MN TDDSs are a major emerging strategy for delivering novel vaccines and treatments for diseases, including skin diseases, allergic diseases, and so on.
Assuntos
Dessensibilização Imunológica , Sistemas de Liberação de Medicamentos , Dermatopatias , Vacinas , Administração Cutânea , Sistemas de Liberação de Medicamentos/métodos , Humanos , Agulhas , Desenvolvimento de Vacinas , Vacinas/administração & dosagem , Vacinas/uso terapêuticoRESUMO
A TECNOLOGIA: descrição da tecnologia: A vacina smallpox e monkeypoxa , conhecida pelos nomes comerciais Imvanex®, Jynneos®, Imvamune® ou MVA (Modified Vaccinia Ankara) é composta pelo vírus vaccinia Ankara vivo, atenuado e modificado1 . Como o nome já diz, a vacina é indicada para a profilaxia, em adultos, de infecções provocadas pelos vírus Smallpox (causador da varíola humana) e Monkeypox, ambos do gênero ortopoxvírus. Essa vacina é produzida pela empresa Bavarian Nordic, sendo sua apresentação farmacêutica em frasco com suspensão injetável na concentração 0,5 mlb por dose. É administrada por via subcutânea na posologia de duas doses de 0,5 ml em um intervalo de 28 dias. A vacina deve ser armazenada em temperatura de -20°C a +/-5°C, tendo validade de 36 meses. Pode ser conservada entre -60°C a -40ºC por 60 meses a partir da data de fabricação e, após descongelada, poderá ser mantida a 2°C a 8°C por 12 horas. Condição clínica: O vírus que causa a doença monkeypox é um ortopoxvírus, membro da família Poxviridae. Os sintomas são semelhantes aqueles da varíola humana (smallpox), mas menos graves. A família Poxviridae é composta por vírus epiteliotróficos, ou seja, que são capazes de afetar pele e mucosa em vários sítios corporais. São capazes de infectar uma variedade de animais, incluindo insetos, pássaros, répteis, marsupiais e mamíferos. O mais conhecido de todos os ortopoxvírus é o Smallpox, agente causador da varíola humana (variola major ou smallpox disease); outros membros da família são os vírus Monkeypox, Cowpox, Orf e vaccínia. INFORMAÇÕES REGULATÓRIAS: Informações sobre registro: A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou no dia 25 de agosto de 2022 a dispensa de registro para que o Ministério da Saúde importe e utilize no Brasil a vacina (nomes comerciais Jynneos® ou Imvanex®) para imunização contra a monkeypox. A dispensa temporária e excepcional se aplica somente ao Ministério da Saúde e terá validade de seis meses, desde que não seja expressamente revogada pela Anvisa2 . A indicação está condicionada à prevenção de smallpox e monkeypox em adultos com idade a partir de 18 anos e alto risco de infecção por essas doenças. A administração deve ser realizada em posologia de duas doses (0,5 ml) com um intervalo de 28 dias. PANORAMA DE DESENVOLVIMENTO: Estratégia de busca: Os ensaios clínicos com o uso da vacina smallpox e monkeypox (Imvanex®, Jynneos® ou Imvamune) para a prevenção da monkeypox foram identificados, inicialmente, na base de pesquisa clínica clinicaltrials.gov em 04 de agosto de 2022, com atualização em 26 de agosto de 2022. Foram incluídos ensaios clínicos em qualquer fase em andamento e/ou finalizados, em até cinco anos com o uso de tecnologias para a indicação de monkeypox. Além disso, foram consultadas as bases eletrônicas MEDLINE (via PubMed), EMBASE (via Periódicos Capes), Cochrane Library e o Cortellis da Clarivate Analytics1 em 26 de agosto de 2022. As estratégias de busca foram elaboradas com os termos relacionado à doença e à tecnologia, assim como seus sinônimos e códigos de pesquisa, sem filtro para a fase de desenvolvimento. CONSIDERAÇÕES FINAIS: A monkeypox tem sido considerada uma doença tropical negligenciada da África Ocidental e Central há alguns anos. Entretanto, desde o início de maio de 2022, um surto da doença envolveu a maioria dos países europeus, bem como as Américas do Norte e do Sul, fazendo com que as autoridades de saúde trabalhassem rapidamente para controlar sua disseminação. Uma das estratégias avaliadas é a vacinação da população para a prevenção da doença. O vírus que causa a monkeypox é um ortopoxvírus, membro da família Poxviridae, mesma família da smallpox (varíola humana). A monkeypox possui sintomas semelhantes aos observados no passado em pacientes com a varíola humana, embora seja clinicamente menos grave. Com a erradicação da varíola humana, em 1980, e o subsequente encerramento da vacinação em todo o mundo, a monkeypox emergiu como o ortopoxvírus mais importante para a saúde pública. Embora a vacinação contra a varíola humana tenha sido protetora no passado, atualmente, pessoas com menos de 40 a 50 anos de idade (dependendo do país) podem ser mais suscetíveis à monkeypox devido à cessação das campanhas de vacinação contra a smallpox em todo o mundo após a erradicação da doença. Nesse sentido, a vacinação que vem ocorrendo em alguns países com a vacina para a prevenção da monkeypox na população mais susceptível, principalmente profissionais de saúde, tem grande importância para a saúde pública. Vale ressaltar que a vacina, cujo nome comercial é Imvanex® no Reino Unido e na Europa, Jynneos® nos EUA e Imvamune® no Canadá, são o mesmo produto e contém a vacina de vírus Ankara modificado (vivo atenuado de replicação deficiente), na concentração com título não inferior a 5 x 10 Inf. U (Inf. U = infectious units ou unidades de infecção) por dose de 0,5 ml, todos fabricados pela mesma empresa Bavarian Nordic. Em 25 de agosto de 2022, a Anvisa concedeu a dispensa de registro temporário dessa vacina para o Ministério da Saúde, considerando a emergência em saúde do momento e o atendimento aos interesses do Sistema Único de Saúde, para garantir a celeridade no acesso à vacina para a população em risco. Os dados que embasaram os registros nas agências sanitárias internacionais, bem como a decisão da Anvisa, foram obtidos de estudos em animais, os quais demostraram proteção contra o vírus monkeypox em primatas não humanos vacinados com Imvanex® e de estudos para a proteção contra smallpox em humanos. Assim, a empresa Bavarian Nordic tem patrocinado estudos observacionais que estão sendo conduzidos durante o surto de monkeypox na Europa para confirmar os benefícios da vacina contra a doença.
Assuntos
Humanos , Vacinas/administração & dosagem , Vírus da Varíola dos Macacos/efeitos dos fármacos , Varíola dos Macacos/prevenção & controle , Brasil , Eficácia , Análise Custo-Benefício , Projetos de Desenvolvimento Tecnológico e InovaçãoRESUMO
Encouraging vaccine uptake is important to reducing the impact of infectious disease. However, negative attitudes and vaccine hesitancy, due in part to worry about side effects, are obstacles to achieving high vaccination rates. Provided vaccine information sheets typically include a list of side effects without numeric information about their likelihoods, but providing such numbers may yield benefits. We investigated the effect of providing numeric information about side-effect likelihood (e.g., "1%") and verbal labels (e.g., "uncommon") on intentions to get a hypothetical vaccine, reasons for the vaccination decision, and risk overestimation. In a diverse, online, convenience sample (N = 595), providing numeric information increased vaccine intentions-70% of those who received numeric information were predicted to be moderately or extremely likely to vaccinate compared to only 54% of those who did not receive numeric information (p<.001), controlling for age, gender, race, education, and political ideology. Participants receiving numeric information also were less likely to overestimate side-effect likelihood. Verbal labels had additional benefits when included with numeric information, particularly among the vaccine hesitant. For these participants, verbal labels increased vaccine intentions when included with numeric information (but not in its absence). Among the vaccine-hesitant, 43% of those provided numeric information and verbal labels were predicted to be moderately or extremely likely to get vaccinated vs. only 24% of those given a list of side effects (p<.001). We conclude that the standard practice of not providing numeric information about side-effect likelihood leads to a less-informed public who is less likely to vaccinate.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Conhecimentos, Atitudes e Prática em Saúde , Hesitação Vacinal/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Vacinas , Humanos , Intenção , Vacinação/efeitos adversos , Vacinas/administração & dosagem , Vacinas/efeitos adversosRESUMO
To determine the safety and efficacy profile of teenager COVID-19 vaccination. In this retrospective cohort study, contact numbers of parents of teenagers under 18 years of age referred to a teenager vaccination centers in Tehran-Iran to receive the corona vaccine were collected, and the following information was obtained via the phones: demographic information, type of vaccine, and the number of doses received, as well as additional information like complications and required treatments. Eleven thousand forty-two subjects aged 10-18 years, mean age 14.55 ± 1.83 year including 5374 boys and 5768 girls were investigated. 88.1% received the Sinopharm and 11.9% the Soberana vaccine. General side effects, including fatigue, fever and chills, injection site pain and dizziness, and so forth happened in 2978 cases; 7421 children presented with at least one general or organ-specific side effect following vaccination, including potentially critical side effects, such as vascular injuries, respiratory complication, and so forth. 0.1% of the subject needed hospital admission. The breakthrough infection happened in 200 individuals. Our study shows that Sinopharm and Soberana (PastoCoVac) COVID-19 vaccines are generally safe with no serious side effects in less than 18 years old. COVID-19 infection and reinfection can occur after vaccination, but the incidence is actually tolerable and significantly lower than in the unvaccinated group.
Assuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Adolescente , COVID-19/epidemiologia , Vacinas contra COVID-19/administração & dosagem , Criança , Estudos de Coortes , Feminino , Humanos , Irã (Geográfico)/epidemiologia , Masculino , Estudos Retrospectivos , Vacinação/efeitos adversos , Vacinas/administração & dosagem , Vacinas/classificaçãoRESUMO
Due to the inherent complex nature of clinical trials, individual's willingness to participate and hence, enrollment in a clinical trial maybe challenging. When it comes to vaccine clinical trial in children, informed consent needs to be secured from the parents or legally acceptable representatives (LARs). Some of the factors which contribute to hesitancy in taking part in clinical trials are based on the level of education, living standards, part of the world they live, associated burden of disease, fear of different procedures in clinical trial, side effects, limited understanding, limited time, and mistrust with Investigational product. This study included 201 parents/LARs, who approached Kanti Children Hospital site in Kathmandu with the interest to get their children enrolled in a vaccine clinical trial with objectives of describing the reasons for agreeing or disagreeing to participate in the vaccine clinical trial, factors affecting decision making, and finding the major concerns of parents/LARs. The acceptance for the study vaccine was 136 (67.7%) whereas denial was 65 (32.3%). This study showed that age, education level, family structure, advice from family and friends, and medical guidance play important roles in willingness of parents to get their child enrolled in the trial. If a proper counseling is done, fear of blood sampling is not a big factor which is contrary to the belief among clinical researchers. Safety of vaccine, frequency of injections, and cost of vaccine were the main concerns of the parents, which need to be addressed extensively while planning for any clinical trial in children.
Assuntos
Ensaios Clínicos como Assunto , Participação do Paciente , Vacinas , Criança , Países em Desenvolvimento , Humanos , Consentimento Livre e Esclarecido/psicologia , Nepal , Pais/psicologia , Participação do Paciente/psicologia , Vacinas/administração & dosagem , Vacinas/efeitos adversosRESUMO
Antigen delivery through an oral route requires overcoming multiple challenges, including gastrointestinal enzymes, mucus, and epithelial tight junctions. Although each barrier has a crucial role in determining the final efficiency of the oral vaccination, transcytosis of antigens through follicle-associated epithelium (FAE) represents a major challenge. Most of the research is focused on delivering an antigen to the M-cell for FAE transcytosis because M-cells can easily transport the antigen from the luminal site. However, the fact is that the M-cell population is less than 1% of the total gastrointestinal cells, and most of the oral vaccines have failed to show any effect in clinical trials. To challenge the current dogma of M-cell targeting, in this study, we designed a novel tandem peptide with a FAE-targeting peptide at the front position and a cell-penetrating peptide at the back position. The tandem peptide was attached to a smart delivery system, which overcomes the enzymatic barrier and the mucosal barrier. The result showed that the engineered system could target the FAE (enterocytes and M-cells) and successfully penetrate the enterocytes to reach the dendritic cells located at the subepithelium dome. There was successful maturation and activation of dendritic cells in vitro confirmed by a significant increase in maturation markers such as CD40, CD86, presentation marker MHC I, and proinflammatory cytokines (TNF-α, IL-6, and IL-10). The in vivo results showed a high production of CD4+ T-lymphocytes (helper T-cell) and a significantly higher production of CD8+ T-lymphocytes (killer T-cell). Finally, the production of mucosal immunity (IgA) in the trachea, intestine, and fecal extracts and systemic immunity (IgG, IgG1, and IgG2a) was successfully confirmed. To the best of our knowledge, this is the first study that designed a novel tandem peptide to target the FAE, which includes M-cells and enterocytes rather than M-cell targeting and showed that a significant induction of both the mucosal and systemic immune response was achieved compared to M-cell targeting.
Assuntos
Imunidade nas Mucosas/efeitos dos fármacos , Nanopartículas/administração & dosagem , Nanopartículas/química , Administração Oral , Animais , Antígenos/imunologia , Linhagem Celular , Sobrevivência Celular/efeitos dos fármacos , Citocinas/metabolismo , Feminino , Humanos , Concentração de Íons de Hidrogênio , Imunidade , Imunoglobulina A/metabolismo , Imunoglobulina G/metabolismo , Camundongos Endogâmicos C57BL , Nanopartículas/toxicidade , Ovalbumina/imunologia , Nódulos Linfáticos Agregados/imunologia , Baço/efeitos dos fármacos , Células Th1/metabolismo , Células Th2 , Vacinas/administração & dosagem , Vacinas/síntese química , Vacinas/química , Vacinas/farmacocinéticaRESUMO
BACKGROUND: Between May 2005 and March 2007, three vaccines were recommended by the Advisory Committee on Immunization Practices for routine use in adolescents in the United States: quadrivalent meningococcal conjugate vaccine (MenACWY), tetanus, diphtheria and acellular pertussis vaccine (Tdap), and human papillomavirus vaccine (HPV). Understanding historical adolescent vaccination patterns may inform future vaccination coverage efforts for these and emerging adolescent vaccines, including COVID-19 vaccines. METHODS: This was a descriptive, retrospective cohort study. All vaccines administered to adolescents aged 11 through 18 years in the Vaccine Safety Datalink population between January 1, 2007 and December 31, 2016 were examined. Vaccination coverage was assessed by study year for ≥1 dose Tdap or Td, ≥1 dose Tdap, ≥1 dose MenACWY, ≥1 dose HPV, and ≥3 dose HPV. The proportion of vaccine visits with concurrent vaccination (≥2 vaccines administered at the same visit) was calculated by sex and study year. The most common vaccine combinations administered in the study population were described by sex for two time periods: 2007-2010 and 2011-2016. RESULTS: The number of 11-18-year-olds in the study population averaged 522,565 males and 503,112 females per study year. Between January 2007 and December 2016 there were 4,884,553 vaccine visits in this population (45% among males). The overall proportion of concurrent vaccine visits among males was 43% (33-61% by study year). Among females, 39% of all vaccine visits included concurrent vaccination (32-48% by study year). Vaccine coverage for Tdap, MenACWY, and 1- and 3-dose HPV increased across the study period. A wide variety of vaccine combinations were administered among both sexes and in both time periods. CONCLUSIONS: The high vaccine uptake and multitude of vaccine combinations administered concurrently in the adolescent population of the Vaccine Safety Datalink provide historical patterns with which to compare future adolescent vaccination campaigns.
Assuntos
Vacinação , Vacinas , Adolescente , COVID-19 , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Feminino , Humanos , Esquemas de Imunização , Masculino , Vacinas Meningocócicas/administração & dosagem , Vacinas Meningocócicas/efeitos adversos , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Estudos Retrospectivos , SARS-CoV-2 , Estados Unidos , Vacinação/tendências , Vacinas/administração & dosagem , Vacinas/efeitos adversosRESUMO
BACKGROUND: Childhood immunization is one of the most cost-effective prevention measures for children's mortality and morbidity, saving 2-3 million lives per year. In Ethiopia, under-five mortality rates, about 190,000 children die each year. Different research conducted in Ethiopia on childhood vaccination have focused on either vaccination coverage of individual vaccine or complete and incomplete vaccination. As far as my literature searching, studies separated the vaccination status into non-vaccinated, partially vaccinated and full vaccinated and assorted factors among children age 12-23 month in Ethiopia were limited. Therefore, the aim of this study was to identify factors associated with vaccination status among children 12-23 months of age in Ethiopia. METHOD: A secondary data analysis was done based on the 2016 Ethiopian Demographic and Health Survey (EDHS). A total weighted sample of 1911 children age 12-23 months of age were included in the study. Logit based Multinomial logistic regression analysis was computed to distinguish factors associated with routine vaccination of children aged 12-23 months. P-value less than 0.05 was used to declare statistical significance of each independent variables, and adjusted odd ratio (AOR) with 95% confidence interval were used to present the result and STATA 14 was utilized for data management and analysis. RESULT: Overall the prevalence of full vaccinated children was 35%, while 49% of children were partially vaccinated and 16% were non-vaccinated. In multinomial analysis, having focused ANC (at least four visits) contrasted to no ANC visits at all had 9.7 higher odd of being fully vaccinated than not vaccinated [AOR = 9.74, 95% CI = 3.52-26.94], and 5 times higher odd of being partially vaccinated than not vaccinated [AOR = 4.97, 95% CI = 2.00-12.33]. CONCLUSION: The present study found that childhood full vaccination status was low compared with the World Health Organization targets. Frequency of ANC visit and visited by field worker were significantly associated both partially and full vaccination whereas, visited health facility last 12 months and wealth status were significantly associated with childhood full vaccination.