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J Exp Med ; 216(9): 2057-2070, 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31270247


Vaccination against measles, mumps, and rubella (MMR) and yellow fever (YF) with live attenuated viruses can rarely cause life-threatening disease. Severe illness by MMR vaccines can be caused by inborn errors of type I and/or III interferon (IFN) immunity (mutations in IFNAR2, STAT1, or STAT2). Adverse reactions to the YF vaccine have remained unexplained. We report two otherwise healthy patients, a 9-yr-old boy in Iran with severe measles vaccine disease at 1 yr and a 14-yr-old girl in Brazil with viscerotropic disease caused by the YF vaccine at 12 yr. The Iranian patient is homozygous and the Brazilian patient compound heterozygous for loss-of-function IFNAR1 variations. Patient-derived fibroblasts are susceptible to viruses, including the YF and measles virus vaccine strains, in the absence or presence of exogenous type I IFN. The patients' fibroblast phenotypes are rescued with WT IFNAR1 Autosomal recessive, complete IFNAR1 deficiency can result in life-threatening complications of vaccination with live attenuated measles and YF viruses in previously healthy individuals.

Vaccine ; 36(28): 4112-4117, 2018 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-29784469


In 2009, Bio-Manguinhos conducted a dose-response study with the yellow fever vaccine, administering the vaccine in the usual mean dose of 27,476 IU (full dose, reference) and in tapered doses (10,447 IU, 3013 IU, 587 IU, 158 IU, and 31 IU) by the usual subcutaneous route and usual volume (0.5 mL). Tapered doses were obtained by dilution in the manufacturer's laboratory, and the test batches presented industrial quality. Doses down to 587 IU showed similar immunogenicity to the full dose (27,476, reference), while the 158 IU and 31 IU doses displayed lower immunogenicity. Seropositivity was maintained at 10 months, except in the group that received the 31 IU dose. The current study aims to determine whether yellow fever seropositivity was maintained eight years after YF vaccination in non-revaccinated individuals. According to the current study's results, seropositivity was maintained in 85% of 318 participants and was similar across groups. The findings support the use of the yellow fever vaccine in fractional doses during outbreaks, but each fractional dose should have at least 587 IU. This study also supports the minimum dose required by WHO, 1000 IU. CLINICAL TRIALS REGISTRATION: NCT 03338231.

Vacina contra Febre Amarela/imunologia , Febre Amarela/prevenção & controle , Estudos de Coortes , Relação Dose-Resposta Imunológica , Humanos , Injeções Subcutâneas , Masculino , Militares , Fatores de Tempo , Voluntários , Vacina contra Febre Amarela/administração & dosagem
Vaccine ; 32(49): 6676-82, 2014 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-24837504


Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus.

Doenças do Sistema Nervoso Central/induzido quimicamente , Vacina contra Febre Amarela/administração & dosagem , Vacina contra Febre Amarela/efeitos adversos , Febre Amarela/prevenção & controle , Adolescente , Adulto , Fatores Etários , Idoso , Brasil , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Adulto Jovem
Hum Vaccin Immunother ; 9(4): 879-88, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23364472


OBJECTIVE: To verify if the Bio-Manguinhos 17DD yellow fever vaccine (17DD-YFV) used in lower doses is as immunogenic and safe as the current formulation. RESULTS: Doses from 27,476 IU to 587 IU induced similar seroconversion rates and neutralizing antibodies geometric mean titers (GMTs). Immunity of those who seroconverted to YF was maintained for 10 mo. Reactogenicity was low for all groups. METHODS: Young and healthy adult males (n = 900) were recruited and randomized into 6 groups, to receive de-escalating doses of 17DD-YFV, from 27,476 IU to 31 IU. Blood samples were collected before vaccination (for neutralization tests to yellow fever, serology for dengue and clinical chemistry), 3 to 7 d after vaccination (for viremia and clinical chemistry) and 30 d after vaccination (for new yellow fever serology and clinical chemistry). Adverse events diaries were filled out by volunteers during 10 d after vaccination. Volunteers were retested for yellow fever and dengue antibodies 10 mo later. Seropositivity for dengue was found in 87.6% of volunteers before vaccination, but this had no significant influence on conclusions. CONCLUSION: In young healthy adults Bio-Manguinhos/Fiocruz yellow fever vaccine can be used in much lower doses than usual. INTERNATIONAL REGISTER: ISRCTN 38082350.

Relação Dose-Resposta Imunológica , Vacinação/métodos , Vacina contra Febre Amarela/administração & dosagem , Vacina contra Febre Amarela/imunologia , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Voluntários Saudáveis , Humanos , Masculino , Fatores de Tempo , Vacinação/efeitos adversos , Vacina contra Febre Amarela/efeitos adversos , Adulto Jovem
J Infect Dis ; 204 Suppl 2: S729-36, 2011 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-21954274


BACKGROUND: Brazil conducted mass immunization of women of childbearing age in 2001 and 2002. Surveillance was initiated for vaccination of women during pregnancy to monitor the effects of rubella vaccination on fetal outcomes. METHODS: Women vaccinated while pregnant or prior to conception were reported to the surveillance system. Susceptibility to rubella infection was determined by anti-rubella immunoglobulin (Ig) M and IgG immunoassays. Susceptible women were observed through delivery. Live-born infants were tested for anti-rubella IgM antibody; IgM-seropositive newborns were tested for viral shedding and observed for 12 months for signs of congenital rubella syndrome. Incidence of congenital rubella infection was calculated using data from 7 states. RESULTS: A total of 22 708 cases of rubella vaccination during pregnancy or prior to conception were reported nationwide, 20,536 (90%) of which were from 7 of 27 states in Brazil. Of these, 2332 women were susceptible to rubella infection at vaccination. Sixty-seven (4.1%) of 1647 newborns had rubella IgM antibody (incidence rate, 4.1 congenital infections per 100 susceptible women vaccinated during pregnancy [95% confidence interval, 3.2-5.1]). None of the infants infected with rubella vaccine virus was born with congenital rubella syndrome. CONCLUSIONS: As rubella elimination goals are adopted worldwide, evidence of rubella vaccine safety aids in planning and implementation of mass adult immunization.

Vacina contra Rubéola/administração & dosagem , Vacina contra Rubéola/imunologia , Rubéola (Sarampo Alemão)/congênito , Rubéola (Sarampo Alemão)/prevenção & controle , Adolescente , Adulto , Brasil/epidemiologia , Criança , Controle de Doenças Transmissíveis , Feminino , Seguimentos , Humanos , Incidência , Recém-Nascido , Vacinação em Massa , Vigilância da População , Gravidez , Complicações Infecciosas na Gravidez , Vacina contra Rubéola/efeitos adversos , Adulto Jovem
Vaccine ; 29(37): 6327-34, 2011 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-21640779


A randomized trial was conducted to assess the immunogenicity and reactogenicity of yellow fever vaccines (YFV) given either simultaneously in separate injections, or 30 days or more after a combined measles-mumps-rubella (MMR) vaccine. Volunteers were also randomized to YFV produced from 17DD and WHO-17D-213 substrains. The study group comprised 1769 healthy 12-month-old children brought to health care centers in Brasilia for routine vaccination. The reactogenicity was of the type and frequency expected for the vaccines and no severe adverse event was associated to either vaccine. Seroconversion and seropositivity 30 days or more after vaccination against yellow fever was similar across groups defined by YFV substrain. Subjects injected YFV and MMR simultaneously had lower seroconversion rates--90% for rubella, 70% for yellow fever and 61% for mumps--compared with those vaccinated 30 days apart--97% for rubella, 87% for yellow fever and 71% for mumps. Seroconversion rates for measles were higher than 98% in both comparison groups. Geometric mean titers for rubella and for yellow fever were approximately three times higher among those who got the vaccines 30 days apart. For measles and mumps antibodies GMTs were similar across groups. MMR's interference in immune response of YFV and YFV's interference in immune response of rubella and mumps components of MMR had never been reported before but are consistent with previous observations from other live vaccines. These results may affect the recommendations regarding primary vaccination with yellow fever vaccine and MMR.

Vacina contra Sarampo-Caxumba-Rubéola/antagonistas & inibidores , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , Vacina contra Febre Amarela/antagonistas & inibidores , Vacina contra Febre Amarela/imunologia , Anticorpos Antivirais , Coleta de Dados , Antagonismo de Drogas , Interações de Medicamentos , Feminino , Humanos , Lactente , Masculino , Sarampo/imunologia , Sarampo/prevenção & controle , Vírus do Sarampo/imunologia , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Caxumba/imunologia , Caxumba/prevenção & controle , Vírus da Caxumba/imunologia , Rubéola (Sarampo Alemão)/imunologia , Rubéola (Sarampo Alemão)/prevenção & controle , Vírus da Rubéola/imunologia , Inquéritos e Questionários , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Febre Amarela/imunologia , Febre Amarela/prevenção & controle , Vacina contra Febre Amarela/efeitos adversos , Vírus da Febre Amarela/imunologia
J. pediatr. (Rio J.) ; 83(6): 523-528, Nov.-Dec. 2007. tab
Artigo em Inglês, Português | LILACS | ID: lil-472613


OBJETIVO: Avaliar a segurança da vacina combinada de difteria-tétano-coqueluche de células inteiras e Haemophilus influenzae tipo b usada no Programa Nacional de Imunizações, e em especial a incidência de episódios hipotônicos-hiporresponsivos. MÉTODO: Acompanhamento de uma coorte de 21.064 lactentes (20.925 ou 99,7 por cento aderiram ao protocolo de estudo), nas 48 horas após a aplicação da vacina de difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em centros de saúde na cidade do Rio de Janeiro, para determinar e investigar eventos adversos graves, espontâneos e solicitados. Cada criança foi monitorada durante somente uma dose. RESULTADOS: A incidência de episódios hipotônicos-hiporresponsivos foi de 1:1.744 doses (casos confirmados) e de 1:1.495 doses (casos confirmados mais casos suspeitos). A taxa de incidência de convulsões foi de 1:5.231 doses. Não foram detectados casos de apnéia. Esses resultados são comparáveis àqueles relatados na literatura para a vacina contra difteria-tétano-coqueluche de células inteiras. CONCLUSÃO: A vacina contra difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em estudo pode ser usada com segurança no Programa Nacional de Imunizações, de acordo com as precauções e contra-indicações correntes.

OBJECTIVE:To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes. METHOD: Follow-up of a cohort of 21,064 infants (20,925 or 99.7 percent adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only. RESULTS: The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. CONCLUSION: The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.

Feminino , Humanos , Lactente , Masculino , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Febre/etiologia , Vacinas Anti-Haemophilus/efeitos adversos , Programas de Imunização/estatística & dados numéricos , Convulsões/etiologia , Brasil/epidemiologia , Estudos de Coortes , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Difteria/prevenção & controle , Febre/epidemiologia , Infecções por Haemophilus/prevenção & controle , Vacinas Anti-Haemophilus/administração & dosagem , Incidência , Entrevistas como Assunto , Índice de Gravidade de Doença , Convulsões/epidemiologia , Tétano/prevenção & controle , Coqueluche/prevenção & controle