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1.
Nursing ; 49(12): 42-49, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31764873

RESUMO

Immunization is crucial to maintaining public health. This article addresses the benefits of childhood vaccinations and educates parents on the myths surrounding possible adverse reactions.


Assuntos
Segurança , Vacinas , Criança , Humanos , Lactente , Relações Enfermeiro-Paciente , Pais/educação , Pais/psicologia , Saúde Pública , Medição de Risco , Vacinas/efeitos adversos
2.
Arq. bras. med. vet. zootec. (Online) ; 71(5): 1453-1458, set.-out. 2019. ilus
Artigo em Inglês | LILACS, VETINDEX | ID: biblio-1038653

RESUMO

Cases of compressive myelopathy syndrome associated with post vaccinal pyogranulomas were diagnosed post mortem in three cows from a farm in Minas Gerais state, Brazil. These cows presented ataxia and bilateral paresis of the pelvic limbs, which evolved to paralysis, and sternal recumbence. On necropsy, locally extensive areas of the longissimus dorsi muscle were replaced by pyogranulomas supported by moderate amounts of fibrous connective tissue. On the cut surface, some nodules contained yellowish and viscous fluid (purulent exudate) or whitish fluid (interpreted as the oily adjuvant of a vaccine). In the spinal canal of the subjacent vertebrae, compressing the spinal cord, were pyogranulomas identical to those described in the skeletal muscle. Histologically, the pyogranulomas were composed of a central clear vacuole (consistent with the space left by the oil adjuvant droplets), surrounded by neutrophils and, more externally, by large numbers of epithelioid macrophages and fewer multinucleated giant cells. In the white matter of the spinal cord were numerous well-defined, clear vacuoles (Wallerian degeneration). The association of the clinical history and pathological findings allowed the diagnosis of compressive myelopathy associated with pyogranulomatous reaction to the oily adjuvant of the foot-and-mouth disease vaccine, in this case, due to its inadequate application.(AU)


São descritos casos de síndrome de compressão medular, associada a granulomas pós-vacinais, em bovinos Nelore, provenientes de uma propriedade em Minas Gerais. Esses bovinos apresentavam ataxia e paresia bilateral dos membros pélvicos, que evoluiu para paralisia e decúbito esternal. Na necropsia, áreas focalmente extensas da musculatura na região torácica dorsal (músculo longissimus dorsi) eram substituídas por numerosos piogranulomas, separados por tecido brancacento e firme (tecido conjuntivo fibroso). Ao corte, alguns nódulos continham material amarelado e viscoso (exsudato purulento) ou material esbranquiçado e fluido (sugestivo de adjuvante de vacina). No canal medular das vértebras subjacentes, havia granulomas idênticos aos observados no tecido muscular. Histologicamente, os piogranulomas continham, no centro, vacúolo, bem delimitado e arredondado (consistente com o espaço deixado pela gotícula de lipídio do adjuvante), circundado por variável quantidade de neutrófilos degenerados e íntegros e, mais externamente, por numerosos macrófagos epitelioides e algumas células gigantes multinucleadas. Nas áreas da medula espinhal, circundadas pelos granulomas, numerosos vacúolos, bem definidos, eram observados na substância branca (degeneração walleriana). A associação do histórico clínico e de achados patológicos permitiu o diagnóstico de mielopatia compressiva associada à reação granulomatosa ao adjuvante oleoso da vacina contra febre aftosa, no caso, induzida pela aplicação inadequada da vacina.(AU)


Assuntos
Animais , Feminino , Bovinos , Compressão da Medula Espinal/induzido quimicamente , Compressão da Medula Espinal/veterinária , Doenças da Medula Espinal/veterinária , Vacinas/efeitos adversos , Febre Aftosa/prevenção & controle , Doenças do Sistema Nervoso/veterinária
3.
Expert Opin Drug Saf ; 18(12): 1237-1243, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31538503

RESUMO

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Vacinas/efeitos adversos , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Reino Unido , Adulto Jovem
4.
Pediatrics ; 144(4)2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31527172

RESUMO

The following is the runner-up submission from the third annual Section on Pediatric Trainees essay competition. This year's competition was informed by the 2018-2019 Section on Pediatric Trainees Advocacy Campaign: Advocacy Adventure, which empowered trainees to find their areas of passion, acquire and polish new skills, and organize advocacy efforts collaboratively. We asked writers to share experiences as physician advocates and were impressed with the broad variety of important topics submitted by trainees from around the country. This essay by Dr Ju describes advocating at the California state level for childhood immunization protections, which transformed her perspective of those who hold a different view. Along with the winning submission by Drs Panda and Garg that also appears in this issue, this piece is a wonderfully inspiring reminder that we are all well positioned to advocate for children in our roles as trainees and pediatricians.


Assuntos
Defesa da Criança e do Adolescente/legislação & jurisprudência , Pediatras/educação , Recusa de Vacinação/legislação & jurisprudência , California , Criança , Comunicação , Humanos , Vacinas/efeitos adversos
5.
BMC Public Health ; 19(1): 1166, 2019 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-31455314

RESUMO

BACKGROUND: Vaccine safety surveillance is an essential requirement in vaccination programmes. It supports signal identification, hypothesis generation, and the identification and rectification of gaps in vaccine pharmacovigilance systems. The objectives of this study were to determine the characteristics and trends of adverse events following immunisation (AEFI) and to assess the performance of the Zimbabwe Expanded Immunisation Programme safety surveillance system. METHODS: We carried out a descriptive study of passively collected vaccine-related Individual Case Safety Report (ICSR) data submitted to the World Health Organization global adverse drug reaction database (VigiBase®) from Zimbabwe during the period 1997 to 2017. We extracted AEFI/ICSR data using VigiLyze® for analysis with respect to the demographic distribution, AEFI characteristics, reporting trends over time, ICSR timeliness and case completeness. RESULTS: A total of 272 vaccine-related ICSRs were included in the analyses with a median completeness score of 0.90 interquartile range, IQR (0.63; 0.90). The overall annual reporting rate was 0.58 per 100,000 vaccine doses and the AEFI reporting ratio ranged between 0 and 30.2 AEFI reports per 100,000 surviving infants. The majority of ICSRs were male (55.3%; p value = 0.641) and the median age was 12 (0-168) months. The majority of ICSRs were reported in children who had received measles (n = 133; 48.9%) and OPV/DTP-Hib-HepB (n = 107; 39.3%) vaccines. Of the 387 observed AEFIs, 301 (77.8%) were systemic events and 86 (22.2%) were local reactions. Systemic events were more frequently reported with doses containing the measles antigen (n = 190; 49.1%) while local events were associated with the multiple antigen OPV/DTP-Hib-HepB (n = 62; 16.0%). The multiple antigen OPV/DTP-Hib-HepB was associated with higher rates for injection site abscess (n = 57), pyrexia (n = 27), diarrhea (n = 15), vomiting (n = 12), and seizures (n = 6). The measles antigen was associated with higher rates for rash (n = 44), ocular disorders (n = 26), pyrexia (n = 26), urticaria (n = 22), diarrhea (n = 8), and vomiting (n = 12). CONCLUSIONS: Most of the ICSRs were associated with measles and OPV/DTP-Hib-HepB vaccines. Zimbabwe's vaccine safety surveillance system is still developing and is not yet fully functional. However, the current system provides a reference point for the monitoring of the ongoing AEFI reporting trends and characteristics.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Imunização/efeitos adversos , Vigilância da População , Vacinas/efeitos adversos , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Programas de Imunização/organização & administração , Lactente , Recém-Nascido , Masculino , Farmacovigilância , Zimbábue/epidemiologia
6.
Artigo em Inglês | MEDLINE | ID: mdl-31315166

RESUMO

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70­79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.


Assuntos
Doenças do Sistema Imunitário/epidemiologia , Vacinação/efeitos adversos , Vacinas/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Austrália/epidemiologia , Criança , Pré-Escolar , Exantema/induzido quimicamente , Exantema/epidemiologia , Feminino , Febre/induzido quimicamente , Febre/epidemiologia , Vacina contra Herpes Zoster , Humanos , Programas de Imunização , Lactente , Reação no Local da Injeção/epidemiologia , Masculino , Pessoa de Meia-Idade , Dor/induzido quimicamente , Dor/epidemiologia , Vigilância da População , Vacinação/normas , Vacinação/estatística & dados numéricos , Vacinas/administração & dosagem , Vômito/induzido quimicamente , Vômito/epidemiologia , Adulto Jovem
7.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 661-663, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288334

RESUMO

Vaccination is among the most economic and effective intervention measures to combat infectious diseases. National immunization program is the best approach to achieve the major public health value of vaccines, and is an important sign of equity of medical service. The evidences accumulated by the studies on vaccine safety and economic assessment are the important basis for the decision making for immunization.


Assuntos
Vigilância de Produtos Comercializados , Vacinas/efeitos adversos , Vacinas/economia , China , Análise Custo-Benefício , Humanos , Programas de Imunização/economia , Vacinação/economia
8.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 664-667, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288335

RESUMO

Post-marketing surveillance of vaccine safety is an important measure to detect adverse events following immunization and therefore reduce the harms to public health. The conventional method for safety surveillance is a passive way through spontaneous reporting, which suffer from under-reporting and incomplete. While active surveillance, a newly proposed surveillance method in developed countries, is capable to make up the deficiencies of passive surveillance. The surveillance system of vaccine safety in China is currently using passive surveillance, and facing many problems and challenges. This arouses a need to promote development of an active surveillance system for vaccine safety in China, learning from the experience world-wide. This commentary aims to throw out suggestions for establishing the active surveillance system, according to the specific situation in China and based on a scoping review of literature.


Assuntos
Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , China , Humanos , Literatura de Revisão como Assunto
9.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 719-723, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288344

RESUMO

Objective: To analyze the characterisitics of the death cases suspected to be related to vaccination in Fujian Province from 2012 to 2017. Methods: A total of 33 death cases information which was suspected to be related to the vaccinations from 2012 to 2017 were extracted from Chinese Adverse Events Following Immunization Information System (AEFI). The autopsy reports and the conclusions made by AEFI investigation diagnosis expert committee were collected at the same time. The inoculation data were obtained through the Fujian province Immunization Program Information System. The AEFI incidence, rare vaccine reaction incidences and mortality rates following immunization were figured out to analyze the characterisitics of the death cases associated with vaccination. Results: The age of deuths cases was from 26 days to 52 months. Among 33 cases, 23 were males, and 8 were due to vaccine-related reaction, and the others were due to coincidental events. The number of rare vaccine reaction cases from 2012 to 2017 were 2,3,6,8,7 and 7, respectively. The highest AEFI incidence was measles and rubella combined attenuated live vaccine [38.88 (95%CI: 36.85-40.91)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [2.01 (95%CI: 1.73-2.30)/100 000 dose]. The highest rare vaccine reaction incidence was measles and rubella combined attenuated live vaccine [15.04 (95%CI: 13.78-16.30)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [0.38 (95%CI: 0.25-0.50)/100 000]. The highest mortality rate was inactivated poliomyelitis vaccine [0.26 (95%CI: 0.04-0.54)/100 000 doses], and the lowest mortality rate was measles, mumps and rubella combined attenuated live vaccine [0.01 (95%CI: 0.00-0.08)/100 000 doses]. The Spearman correlation analysis showed that there were correlations between AEFI incidence and rare vaccine reaction incidence (r=0.64, P=0.048), there were no correlations between AEFI incidence and mortality rate (r=-0.34, P=0.329), and there were no correlations between rare vaccine reaction incidence and mortality rate (r=-0.25, P=0.484). Conclusion: Neither AEFI incidence nor rare vaccine reaction incidence was correlation with mortality rate. The main causes of death following vaccination were coincidental events.


Assuntos
Vacinação/mortalidade , Vacinas/efeitos adversos , Causas de Morte , Pré-Escolar , China/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino
10.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(7): 724-730, 2019 Jul 06.
Artigo em Chinês | MEDLINE | ID: mdl-31288345

RESUMO

Objective: To identify post-marketing active surveillance systems for vaccine safety around the world and understand their features and mechanisms, in order to provide guidance for vaccine administration activities in China. Methods: Following the steps of scoping review, literature about active surveillance system for vaccine safety and published by 30 June 2018 were identified by searching electronic databases, including PubMed, Scopus, and Cochrane Library. Grey literature were also sought by exploring relevant websites. Identified literature were screened according to eligibility criteria, and informative data from included literature were then charted. Framework Synthesis and Thematic Analysis were performed to integrate the charted data. Results: 97 pieces of literature were included for review, and 11 active surveillance systems for vaccine safety were identified, mostly located in developed countries. These systems were constructed by 3 types of organizations: administration departments, academic or research institutions, and health care providers. Their data sources included immunization registries, electronic medical records, claims data, case reports of adverse events following immunization electronic questionnaires, and epidemiologic study data. According to their operation procedures, these systems were grouped into 4 modes of active surveillance: Data Linkage, Investigator Network, Automatic Follow-up System, Studies Consortium. Conclusion: Practice of active surveillance for vaccine safety greatly varies across countries, with different conditions and advantages. It is suggested that developing countries should choose suitable mode of active surveillance considering their local situations.


Assuntos
Vigilância de Produtos Comercializados/métodos , Vacinas/efeitos adversos , China , Países em Desenvolvimento , Humanos
13.
Br J Nurs ; 28(9): 588-589, 2019 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-31070963

RESUMO

Emeritus Professor Alan Glasper, University of Southampton, reflects on media coverage of the use of vaccines and discusses a range of initiatives to address public fears around immunisation through vaccination.


Assuntos
Atitude Frente a Saúde , Medo , Vacinação/psicologia , Educação em Saúde , Humanos , Meios de Comunicação de Massa , Pais/psicologia , Sociedades , Reino Unido , Vacinas/administração & dosagem , Vacinas/efeitos adversos , Organização Mundial da Saúde
14.
BMC Med Inform Decis Mak ; 19(1): 101, 2019 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-31138219

RESUMO

BACKGROUND: Vaccination has been one of the most successful public health interventions to date, and the U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) currently contains more than 500,000 reports for post-vaccination adverse events that occur after the administration of vaccines licensed in the United States. The VAERS dataset is huge, contains very large dimension nominal variables, and is complex due to multiple listing of vaccines and adverse symptoms in a single report. So far there has not been any statistical analysis conducted in attempting to identify the cross-board patterns on how all reported adverse symptoms are related to the vaccines. METHODS: For studies of the relationship between vaccines and reported adverse events, we consider a partial VAERS dataset which includes all reports filed over a period of 24 years between 1990-2013. We propose a neighboring method to process this dataset for dealing with the complications caused by multiple listing of vaccines and adverse symptoms in a single report. Then, the combined approaches based on our neighboring method and novel utilization of data visualization techniques are employed to analyze the large dimension dataset for characterization of the cross-board patterns of the relations between all reported vaccines and events. RESULTS: The results of our analysis indicate that those events or symptoms with overall high occurrence frequencies are positively correlated, and those most frequently occurred adverse symptoms are mostly uncorrelated or negatively correlated under different bacteria vaccines, but they are in many cases positively correlated under different virus vaccines, especially under flu vaccines. No particular patterns are shown under live vs. inactive vaccines. CONCLUSIONS: This article identifies certain cross-board patterns of the relationship between the vaccines and the reported adverse events or symptoms. This helps for better understanding the VAERS data, and provides a useful starting point for the development of statistical models and procedures to further analyze the VAERS data.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos , Vacinas/efeitos adversos , Conjuntos de Dados como Assunto , Humanos , Estados Unidos
15.
Rev Neurol (Paris) ; 175(6): 341-357, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31036391

RESUMO

OBJECTIVES: To establish recommendations on immunization for patients with multiple sclerosis (MS). BACKGROUND: Vaccines have been suspected in the past to trigger MS and relapses. With the extension of the immunoactive treatment arsenal, other concerns have been raised more recently about an increased risk of infection or a decreased effectiveness of immunization in immunosuppressed patients. METHODS: The French Group for Recommendations into Multiple Sclerosis (France4MS) performed a systematic search of papers in Medline and other university databases (January 1975-June 2018). The RAND/UCLA appropriateness method was chosen to review the scientific literature and to formalize the degree of agreement among experts on 5 clinical questions related to immunization and MS. Readers from the steering committee conducted a systematic analysis, wrote a critical synthesis and prepared a list of proposals that were evaluated by a rating group of 28 MS experts. The final version of the recommendations was finally reviewed by a reading group of 110 health care professionals and classified as appropriate, inappropriate or uncertain. RESULTS: Neurologists should verify the vaccination status as soon as MS is diagnosed and before disease-modifying treatments (DMTs) are introduced. The French vaccination schedule applies to MS patients and seasonal influenza vaccination is recommended. In the case of treatment-induced immunosuppression, MS patients should be informed about the risk of infection and the vaccination standards of the French High Council of Health should be applied. Live attenuated vaccines are contra-indicated in patients recently treated with immunosuppressive drugs, including corticosteroids; other vaccines can be proposed whatever the treatment, but their effectiveness may be partly reduced with some drugs. CONCLUSION: Physicians and patients should be aware of the updated recommendations for immunizations of patients with MS.


Assuntos
Imunização/normas , Esclerose Múltipla/imunologia , Esclerose Múltipla/terapia , Prática Clínica Baseada em Evidências , França , Humanos , Imunização/efeitos adversos , Imunização/métodos , Esquemas de Imunização , Guias de Prática Clínica como Assunto , Recidiva , Fatores de Risco , Sociedades Médicas/organização & administração , Sociedades Médicas/normas , Vacinação/efeitos adversos , Vacinação/métodos , Vacinas/efeitos adversos , Vacinas/uso terapêutico
16.
Autoimmun Rev ; 18(7): 691-705, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31059838

RESUMO

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multifactorial and poorly undersood disabling disease. We present epidemiological, clinical and experimental evidence that ME/CFS constitutes a major type of adverse effect of vaccines, especially those containing poorly degradable particulate aluminum adjuvants. Evidence has emerged very slowly due to the multiplicity, lack of specificity, delayed onset, and frequent medical underestimation of ME/CFS symptoms. It was supported by an epidemiological study comparing vaccinated vs unvaccinated militaries that remained undeployed during Gulf War II. Affected patients suffer from cognitive dysfunction affecting attention, memory and inter-hemispheric connexions, well correlated to brain perfusion defects and associated with a stereotyped and distinctive pattern of cerebral glucose hypometabolism. Deltoid muscle biopsy performed to investigate myalgia typically yields macrophagic myofasciitis (MMF), a histological biomarker assessing longstanding persistency of aluminum agglomerates within innate immune cells at site of previous immunization. MMF is seemingly linked to altered mineral particle detoxification by the xeno/autophagy machinery. Comparing toxicology of different forms of aluminum and different types of exposure is misleading and inadequate and small animal experiments have turned old dogma upside down. Instead of being rapidly solubilized in the extracellular space, injected aluminum particles are quickly captured by immune cells and transported to distant organs and the brain where they elicit an inflammatory response and exert selective low dose long-term neurotoxicity. Clinical observations and experiments in sheep, a large animal like humans, confirmed both systemic diffusion and neurotoxic effects of aluminum adjuvants. Post-immunization ME/CFS represents the core manifestation of "autoimmune/inflammatory syndrome induced by adjuvants" (ASIA).


Assuntos
Adjuvantes Imunológicos/efeitos adversos , Compostos de Alumínio/efeitos adversos , Fasciite/etiologia , Síndrome de Fadiga Crônica/etiologia , Mialgia/etiologia , Miosite/etiologia , Vacinas/efeitos adversos , Animais , Humanos , Macrófagos/imunologia , Vacinação
18.
Infect Dis Clin North Am ; 33(2): 593-609, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31005140

RESUMO

Patients with hematologic malignancy or those who undergo hematopoietic stem cell transplantation experience variable degrees of immunosuppression, dependent on underlying disease, therapy received, time since transplant, and complications, such as graft-versus-host disease. Vaccination is an important strategy to mitigate onset and severity of certain vaccine-preventable illnesses, such as influenza, pneumococcal disease, or varicella zoster infection, among others. This article highlights vaccines that should and should not be used in this patient population and includes general guidelines for timing of vaccination administration and special considerations in the context of newer therapies, recent vaccine developments, travel, and considerations for household contacts.


Assuntos
Neoplasias Hematológicas/complicações , Transplante de Células-Tronco Hematopoéticas , Vacinação/estatística & dados numéricos , Vacinas/administração & dosagem , Ensaios Clínicos como Assunto , Neoplasias Hematológicas/imunologia , Humanos , Esquemas de Imunização , Imunogenicidade da Vacina , Imunossupressão , Guias de Prática Clínica como Assunto , Fatores de Risco , Vacinação/efeitos adversos , Vacinas/efeitos adversos
19.
Zhonghua Liu Xing Bing Xue Za Zhi ; 40(4): 451-456, 2019 Apr 10.
Artigo em Chinês | MEDLINE | ID: mdl-31006207

RESUMO

Objective: Safety and immunogenicity regarding simultaneous vaccination on both hepatitis E and hepatitis B vaccines were studied. Methods: A total of 600 healthy subjects aged 18-60 were recruited in Chaoyang district of Beijing city, from September 2015 to December 2016. Subjects meeting the inclusion and exclusion criteria were randomly divided into 3 groups: the simultaneous vaccination group of hepatitis E and hepatitis B, the hepatitis B vaccination group and the hepatitis E vaccination group. Members of the 3 groups were all inoculated according to the procedure of '0, 1 and 6 months'. Safety and immunogenicity of the simultaneous vaccination group was compared with the individual vaccination groups. Results: Vaccination groups had 601 subjects, involved with having 150 subjects of hepatitis E vaccination group, 159 subjects of hepatitis B vaccination group, and 292 subjects of simultaneous vaccination of hepatitis E and hepatitis B. Local adverse reactions that mostly common seen, would include pain (25.0%, 73/292), redness (12.7%, 37/292), pruritus (9.2%, 27/292), callus (8.9%, 26/292), swelling (8.2%, 24/292) at the inoculation sites. Systemic adverse reactions would include fever (7.2%, 21/292), headache (5.8%, 17/292), muscle pain (5.5%, 16/292) and fatigue (3.4%, 10/292). No serious adverse reactions associated with vaccination were seen. In addition to the higher incidence of pain at the inoculation sites, rest of the adverse reactions was similar to the simultaneous vaccination group or the individual vaccination groups. One month after the completed immunization process, positive rate and geometric mean concentration(GMC) of the HBsAb were not inferior to that of the hepatitis B vaccine group (94.2% vs. 93.8%, 611.6 WU/ml vs. 745.1 WU/ml). Positive rate and GMC of the HEV IgG were not inferior to that of the hepatitis E vaccinated group (98.8% vs. 100.0%, 11.0 WU/ml vs. 18.0 WU/ml). Conclusions: Simultaneous vaccination strategy on hepatitis E and hepatitis B vaccines showed good safety and immunogenicity. It is recommended that hepatitis E and hepatitis B vaccines should be administered to the susceptible population at the same time, in order to protect the liver functions.


Assuntos
Vacinas contra Hepatite B/administração & dosagem , Hepatite B/prevenção & controle , Hepatite E/prevenção & controle , Vacinas/imunologia , Adolescente , Adulto , Pequim , Hepatite B/imunologia , Anticorpos Anti-Hepatite B/sangue , Hepatite E/imunologia , Humanos , Pessoa de Meia-Idade , Vacinação , Vacinas/efeitos adversos , Adulto Jovem
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