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1.
PLoS Negl Trop Dis ; 13(11): e0007800, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31725816

RESUMO

B cell activating factor (BAFF) is a member of the tumor necrosis factor (TNF) superfamily of cytokines that links innate with adaptive immunity. BAFF signals through receptors on B cells, making it an attractive molecule to potentiate vaccine-induced B cell responses. We hypothesized that a rabies virus (RABV)-based vaccine displaying both antigen and BAFF on the surface of the same virus particle would target antigen-specific B cells for activation and improve RABV-specific antibody responses. To test this hypothesis, we constructed a recombinant RABV-based vector expressing virus membrane-anchored murine BAFF (RABV-ED51-mBAFF). BAFF was incorporated into the RABV particle and determined to be biologically functional, as demonstrated by increased B cell survival of primary murine B cells treated ex-vivo with RABV-ED51-mBAFF. B cell survival was inhibited by pre-treating RABV-ED51-mBAFF with an antibody that blocks BAFF functions. RABV-ED51-mBAFF also activated primary murine B cells ex-vivo more effectively than RABV as shown by significant upregulation of CD69, CD40, and MHCII on the surface of infected B cells. In-vivo, RABV-ED51-mBAFF induced significantly faster and higher virus neutralizing antibody (VNA) titers than RABV while not adversely affecting the longevity of the vaccine-induced antibody response. Since BAFF was incorporated into the virus particle and genome replication was not required for BAFF expression in-vivo, we hypothesized that RABV-ED51-mBAFF would be effective as an inactivated vaccine. Mice immunized with 250 ng/mouse of ß-propriolactone-inactivated RABV-ED51-mBAFF showed faster and higher anti-RABV VNA titers compared to mice immunized with inactivated RABV. Together, this model stands as a potential foundation for exploring other virus membrane-anchored molecular adjuvants to make safer, more effective inactivated RABV-based vaccines.


Assuntos
Formação de Anticorpos/imunologia , Fator Ativador de Células B/imunologia , Linfócitos B/imunologia , Vacinas Antirrábicas/imunologia , Raiva/imunologia , Raiva/prevenção & controle , Vírion/imunologia , Adjuvantes Imunológicos , Animais , Anticorpos Antivirais/sangue , Citocinas/metabolismo , Feminino , Imunização , Cinética , Camundongos , Camundongos Endogâmicos C57BL , Vacinas Antirrábicas/efeitos adversos , Vírus da Raiva/genética , Vírus da Raiva/crescimento & desenvolvimento , Vírus da Raiva/imunologia , Vacinação , Vacinas Atenuadas/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Vacinas Sintéticas
2.
Rev Esp Quimioter ; 32(5): 432-439, 2019 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-31558008

RESUMO

OBJECTIVE: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%). 49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines.


Assuntos
Hospedeiro Imunocomprometido , Farmacovigilância , Vacinas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Criança , Pré-Escolar , Feminino , Vacinas contra Hepatite B/administração & dosagem , Vacinas contra Hepatite B/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fotografação , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Estudos Retrospectivos , Espanha , Vacinas Estreptocócicas/administração & dosagem , Vacinas Estreptocócicas/efeitos adversos , Vacinas/administração & dosagem , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
3.
Drugs ; 79(12): 1337-1348, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31372959

RESUMO

Manufacturing influenza virus vaccines using a mammalian cell line rather than embryonated chicken eggs may carry certain advantages. A quadrivalent inactivated influenza virus vaccine produced using the Madin Darby canine kidney cell line has been approved in the EU (Flucelvax® Tetra) and USA (Flucelvax Quadrivalent®; QIVc hereafter) for the prevention of influenza in adults and children. The clinical development of QIVc has built upon that of a cell-based trivalent influenza virus vaccine (TIVc) manufactured using the same processes; the additional influenza B strain contained in QIVc reduces the risk of the strain in the vaccine not matching that in circulation. Pivotal phase III clinical trials in adult and paediatric participants have demonstrated the immunogenicity of QIVc to be noninferior to that of TIVc formulations against shared strains and superior against the influenza B strain absent from each TIVc formulation. Protective efficacy data for TIVc is considered foundational for QIVc and, in a phase III clinical trial, TIVc was effective in protecting adults against antigenically matched influenza strains. Large real-world studies from the 2017/2018 US influenza season further support the prophylactic effectiveness of QIVc, with possible benefits over egg-based vaccines. QIVc was generally well tolerated in clinical trials. In adult and paediatric QIVc recipients, the most common solicited adverse reactions were injection site pain and headache. Reactogenicity was comparable to that of TIVc; no safety signals unique to QIVc emerged. Through circumventing concerns around egg adaptation, QIVc has the potential to be more effective than currently available egg-based quadrivalent vaccines.


Assuntos
Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Adulto , Animais , Criança , Ensaios Clínicos como Assunto , Ensaios Clínicos Fase III como Assunto , Cães , Aprovação de Drogas , Europa (Continente) , Humanos , Vacinas contra Influenza/efeitos adversos , Células Madin Darby de Rim Canino , Estados Unidos , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia
4.
J Microbiol Immunol Infect ; 52(5): 685-692, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31255574

RESUMO

BACKGROUND: Development of an efficacious egg-free mock-up H5N1 vaccine is key to our preparedness against pandemic avian flu. METHODS: This is a single-center, randomized, observer-blinded phase I clinical trial evaluating the safety and immunogenicity of an alum-adjuvanted Madin-Darby canine kidney (MDCK)-derived inactivated whole-virion H5N1 influenza vaccine in healthy adults. Hemagglutination inhibition (HAI) and neutralizing antibody titers were measured using horse and turkey red blood cells (RBCs). RESULTS: Thirty-six adult subjects were randomized to receive two doses of 0.5 mL of the MDCK-derived H5N1 alum-adjuvanted vaccine containing 7.5, 15, or 30 µg of hemagglutinin (HA) 21 days apart. The candidate vaccine was well tolerated and safe across the three dosing groups. The most frequent adverse event was injection site pain (46.5%). Both HAI and neutralizing antibody titers increased after each vaccination in all three dosing groups. The best HAI responses, namely a seroconversion rate of 91.7% and a geometric mean ratio of 9.51 were achieved with the HA dose of 30 µg assayed using horse RBCs at day 42. HAI titers against H5N1 avian influenza virus was significantly higher when measured using horse RBCs compared with turkey RBCs. CONCLUSIONS: This Phase I trial showed the MDCK-derived H5N1 candidate vaccine is safe and immunogenic. The source of RBCs has a significant impact on the measurement of HAI titers (ClinicalTrials.gov number: NCT01675284.).


Assuntos
Adjuvantes Imunológicos/administração & dosagem , Imunogenicidade da Vacina , Virus da Influenza A Subtipo H5N1/imunologia , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Segurança , Adjuvantes Imunológicos/efeitos adversos , Adulto , Compostos de Alumínio/administração & dosagem , Animais , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Aves , Cães , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/fisiopatologia , Feminino , Testes de Inibição da Hemaglutinação , Glicoproteínas de Hemaglutininação de Vírus da Influenza/imunologia , Cavalos , Humanos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Aviária , Injeções Intramusculares , Células Madin Darby de Rim Canino , Masculino , Pessoa de Meia-Idade , Pandemias/prevenção & controle , Soroconversão , Taiwan , Vacinação/efeitos adversos , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
5.
PLoS One ; 14(6): e0218033, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31211792

RESUMO

This open-label study assessed the safety and immunogenicity of two doses (14 days apart) of an indigenously manufactured, killed, bivalent (Vibrio cholerae O1 and O139), whole-cell oral cholera vaccine (SHANCHOL; Shantha Biotechnics) in healthy adults (n = 100) and children (n = 100) in a cholera endemic area (Vellore, South India) to fulfill post-licensure regulatory requirements and post-World Health Organization (WHO) prequalification commitments. Safety and reactogenicity were assessed, and seroconversion rates (i.e. proportion of participants with a ≥ 4-fold rise from baseline in serum vibriocidal antibody titers against V. cholerae O1 Inaba, O1 Ogawa and O139, respectively) were determined 14 days after each vaccine dose. No serious adverse events were reported during the study. Commonly reported solicited adverse events were headache and general ill feeling. Seroconversion rates after the first and second dose in adults were 67.7% and 55.2%, respectively, against O1 Inaba; 47.9% and 45.8% against O1 Ogawa; and 19.8% and 20.8% against O139. In children, seroconversion rates after the first and second dose were 80.2% and 68.8%, respectively, against O1 Inaba; 72.9% and 67.7% against O1 Ogawa; and 26.0% and 18.8% against O139. The geometric mean titers against O1 Inaba, O1 Ogawa, and O139 in both adults and children were significantly higher after each vaccine dose compared to baseline titers (P < 0.001; for both age groups after each dose versus baseline). The seroconversion rates for O1 Inaba, O1 Ogawa, and O139 in both age groups were similar to those in previous studies with the vaccine. In conclusion, the killed, bivalent, whole-cell oral cholera vaccine has a good safety and reactogenicity profile, and is immunogenic in healthy adults and children. Trial Registration: ClinicalTrials.gov NCT00760825; CTRI/2012/01/002354.


Assuntos
Vacinas contra Cólera/administração & dosagem , Cólera/imunologia , Imunogenicidade da Vacina , Administração Oral , Adolescente , Adulto , Formação de Anticorpos , Criança , Cólera/microbiologia , Cólera/patologia , Cólera/prevenção & controle , Vacinas contra Cólera/efeitos adversos , Vacinas contra Cólera/imunologia , Feminino , Cefaleia/epidemiologia , Cefaleia/imunologia , Cefaleia/patologia , Humanos , Índia/epidemiologia , Masculino , Vacinação/métodos , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Vibrio cholerae O1/imunologia , Vibrio cholerae O1/patogenicidade , Vibrio cholerae O139/imunologia , Vibrio cholerae O139/patogenicidade , Adulto Jovem
6.
J Infect Dis ; 220(3): 392-399, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-30891604

RESUMO

BACKGROUND: This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B vaccine (HepB) on day 1 and EV71 vaccine (dose 2) with group A meningococcal polysaccharide vaccine (MenA) on day 30 is not inferior to separate administration of each vaccine. METHODS: The study was designed as a randomized, open-label, noninferiority trial. A total of 775 healthy infants aged 6 months were randomly assigned in a ratio of 1:1:1 to receive simultaneous administration of EV71 vaccine (dose 1) and HepB on day 1 and EV71 vaccine (dose 2) and MenA on day 30 (the SI group); administration of doses 1 and 2 of EV71 vaccine on days 1 and 30, respectively (the SE1 group); or administration of HepB and MenA on days 1 and 30, respectively (the SE2 group). RESULTS: According to the per protocol set, antibody responses against EV71, hepatitis B virus (HBV), and group A meningococcal polysaccharide were similar regardless of administration schedule. With the non-inferiority margin setting at 10%, the seroconversion rates of the three pathogens in the SI group (100% [98.25, 100], 44.84% [38.20, 51.63] and 27.83% [21.91, 34.38]) were not inferior to those in SE1 or SE2 group (100% [98.31, 100], 44.35% [37.82, 51.02] and 29.17% [23.20, 35.72], respectively). Frequencies of adverse reactions to each vaccination regimen were comparable (60.62% in the SI group vs 52.33% in the SE1 group and 56.98% in the SE2 group; P = .16). CONCLUSIONS: Simultaneous administration of combined EV71 vaccine with HepB and MenA has noninferior immunogenicity and safety, compared with separate administration of these vaccines. CLINICAL TRIALS REGISTRATION: NCT03274102.


Assuntos
Formação de Anticorpos/imunologia , Vacinas contra Hepatite B/imunologia , Vacinas Meningocócicas/imunologia , Polissacarídeos Bacterianos/imunologia , Vacinas Combinadas/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Anticorpos Antivirais/imunologia , Enterovirus/imunologia , Infecções por Enterovirus/imunologia , Feminino , Hepatite B/imunologia , Vírus da Hepatite B/imunologia , Humanos , Lactente , Masculino , Infecções Meningocócicas/imunologia , Neisseria meningitidis/imunologia , Vacinação/efeitos adversos
7.
Int J Infect Dis ; 85S: S10-S17, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30904674

RESUMO

OBJECTIVE: To assess the long-term safety of MF59-adjuvanted trivalent influenza vaccine (aIIV3; Fluad™) in adults ≥65 years of age. METHODS: Data from 36 primary vaccination and 7 re-vaccination Phase I through III trials were analyzed; 7532 subjects received aIIV3 and 5198 subjects a nonadjuvanted trivalent inactivated influenza vaccine (IIV3). These trials were evaluated in 2 data poolings: first-dose randomized controlled trials (FD-RCT) and revaccination trials. Spontaneously reported adverse events (AEs) from post-marketing surveillance were also analyzed. RESULTS: The percentages of subjects reporting AEs following vaccination were similar between aIIV3 and IIV3: 24.8% for aIIV3 vs 26.7% for IIV3 (relative risk [RR] 0.94; 95% confidence interval [CI] 0.87-1.01). The percentage of subjects with serious AEs was 6.7% for aIIV3 vs 7.0% for IIV3 (RR 0.95; 95% CI 0.82-1.09). Percentages of subjects with AEs leading to withdrawal, hospitalizations, adverse events of special interest (AESIs), and deaths between vaccination groups were similar. There was no signal of disproportionality for AESIs associated with aIIV3 compared to IIV3 in the post-marketing database. CONCLUSIONS: This integrated safety analysis demonstrates an acceptable safety profile for aIIV3 in adults ≥65 years of age.


Assuntos
Adjuvantes Imunológicos/efeitos adversos , Vacinas contra Influenza/efeitos adversos , Polissorbatos/efeitos adversos , Esqualeno/efeitos adversos , Idoso , Pré-Escolar , Ensaios Clínicos como Assunto , Feminino , Hospitalização , Humanos , Imunização Secundária , Influenza Humana/prevenção & controle , Masculino , Mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Estações do Ano , Vacinas de Produtos Inativados/efeitos adversos
8.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(3): 252-257, 2019 Mar 06.
Artigo em Chinês | MEDLINE | ID: mdl-30841662

RESUMO

Objective: To evaluate the post-marketing safety profiles of the inactivated enterovirus type 71 (EV-A71) vaccine (Vero cell) after routine inoculation. Methods: Eleven cities of Zhejiang Province, Fengtai district of Beijing, Qinnan district, two counties as Pingle and Pingguo of Guangxi Zhuang Autonomous Region, and Dongtai city of Jiangsu Province were selected as the field sites. A total of 45 239 subjects were enrolled in this study from children who seeked the vaccination of EV-A71 vaccine during the period from July, 2016 to June, 2018. Different sampling method were adopted in different sites. All vaccinated children were invited to participate in the study in Fengtai and Dongtai, however, systematic sampling method were adopted in other sites. Active surveillance was conducted and information about adverse reactions (ARs) occurred in 30 min, 3 d and 30 d following each dose of EV-A71 immunization was collected by field observation, phone-call or face-to-face interview. The incidence of ARs in different types, symptoms and grades were described. Results: In total, there were 45 239 children who received 71 243 doses EV-A71 vaccine. The overall incidence of ARs was 1.079% (769 doses), with the highest incidence of 1.182% (177/14 973) in 5-11 month group and the lowest incidence of 0.849% (18/2 119) in ≥ 36 month group among different age groups. There was a higher incidence in solicited ARs, which was 1.047% (746 doses). The incidences of grade 1 and grade 2 ARs were also higher, which were 0.404% (288 doses) and 0.554% (395 doses), respectively. No grade 4 ARs occurred. The doses of the first and the second vaccination was 40 736 and 30 507, respectively, and the incidences of ARs were 1.281% (522 doses) and 0.810% (247 doses). Also, the incidences of ARs were 0.091% (37 doses) and 0.043% (13 doses) in local, and 1.168% (476 doses) and 0.760% (232 doses) in system. The symptoms of ARs after the two doses of vaccination were basically the same. Redness at the injection site was the most common local ARs after each dose vaccination, with doses of 24 and 11, while fever was the most common systemic ARs, with doses of 362 and 190. Moreover, ARs mainly occurred in 30 min to 3 d after each dose vaccination, with incidence of 1.016% (414 doses) and 0.698% (213 doses) in the first and second dose, respectively. Conclusion: The ARs had a low incidence after vaccination in children and most were mild or moderate. EV-A71 vaccine with good safety is suitable for inoculation in a large scale.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Enterovirus/imunologia , Vigilância de Produtos Comercializados , Vacinas Virais/efeitos adversos , Animais , Criança , China/epidemiologia , Infecções por Enterovirus/prevenção & controle , Humanos , Vacinas de Produtos Inativados/efeitos adversos , Células Vero
9.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(3): 258-261, 2019 Mar 06.
Artigo em Chinês | MEDLINE | ID: mdl-30841663

RESUMO

Objective: To evaluate the post-marketing safety of inactivated Enterovirus type 71 (EV-A71) vaccine (human diploid cell) . Methods: A total of 20 191 healthy children aged 6 to 59 months were invited to receive 2 doses of EV-A71 vaccine in Zhejiang Province from September 2016 to December 2017. Child caregivers were followed up on the 4(th) or 5(th) day after each EV-A71 vaccination, and the incidence of local, systemic, and other adverse events within 3 days after vaccination was recorded to assess vaccine safety. Describe the differences in adverse events among children with different characteristics. Results: A total of 32 230 doses were observed in this study, of which 20 191 and 12 039 were vaccinated for the first and the second dose, respectively; and the incidence of adverse events within 3 days was 2.045% (413 doses) and 1.611% (194 doses), respectively. After the first and the second dose, the number of systemic adverse events was the highest, 371 and 175 cases, respectively, with an incidence of 1.837% and 1.454%, respectively; the number of local adverse events was the lowest, 14 and 2 doses, respectively, with an incidence of 0.069% and 0.017%. Local adverse events occurred after vaccination were generally mild, and only 2 patients had level of 3; among the systemic adverse events, 39 patients had a fever level of 3 or higher, accounting for 8.2% of the total fever. Most of the symptoms in the local adverse events did not require treatment, only 3 cases of vaccination site rash and 2 cases of pruritus were self-purchased drugs or outpatient treatment; except for 5 cases of fever, the other symptoms were not hospitalized in the case of systemic adverse events. Conclusion: The incidence of adverse events within 3 days after vaccination with EV-A71 vaccine was low in children, mainly systemic adverse events, and the prognosis was good.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Enterovirus Humano A/imunologia , Vigilância de Produtos Comercializados , Vacinas Virais/efeitos adversos , Pré-Escolar , China/epidemiologia , Diploide , Infecções por Enterovirus/prevenção & controle , Humanos , Lactente , Vacinas de Produtos Inativados/efeitos adversos
10.
Zhonghua Yu Fang Yi Xue Za Zhi ; 53(3): 262-266, 2019 Mar 06.
Artigo em Chinês | MEDLINE | ID: mdl-30841664

RESUMO

Objectives: To evaluate the safety of inactivated enterovirus A71(EV-A71) vaccines after large-scale immunization in the community. Methods: We selected EV-A71 susceptible people (healthy children) aged 6-59 months in vaccination clinics from 89 counties in Zhejiang Province between April 2016 and March 2018. All local and systematic adverse actions were collected by 30 min on-site inspection, within 3 days and 4-30 days follow-up. Chi-square test and Fisher's exact test were used to compare the difference of AEs incidence in various characteristics among two groups. Results: A total of 71 663 doses of vaccines were included for active safety analysis, which included 37 331 doses in boys and 34 332 doses in girls. Among all the doses, children aged 6 to 11 months, 12 to 23 months and 24 to 59 months were received 13 707, 32 639 and 25 317 doses respectively. The incidence of adverse reactions within 30 min, 3 days and 4-30 days were 0.33% (239 doses), 1.58% (1 133 doses) and 0.34% (244 doses) respectively. Adverse reactions within 3 days were 1 372 doses, with a incidence of 1.91%; among all the cases, 539 doses (0.75%) were grade 1, 677 doses (0.94%) were grade 2 and 156 doses (0.22%) were grade 3, no grade-4 adverse reaction was reported. The common local adverse reactions were redness, swelling and pruritus, with the incidence rates were 0.05% (39 doses), 0.02% (16 doses) and 0.02% (12 doses), respectively, while the most common systemic adverse reaction was pyrexia with an incidence of 1.19% (856 doses), followed by diarrhea and anorexia with the incidence rates were 0.15% (104 doses) and 0.13% (90 doses) respectively. Conclusion: Most adverse actions of EV-A71 vaccines were mild and moderate and majority of them were common adverse actions. No new adverse reactions were found in the study.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Enterovirus Humano A/imunologia , Vigilância de Produtos Comercializados , Vacinas Virais/efeitos adversos , Pré-Escolar , China/epidemiologia , Infecções por Enterovirus/prevenção & controle , Feminino , Humanos , Lactente , Masculino , Vacinas de Produtos Inativados/efeitos adversos
11.
Medicine (Baltimore) ; 98(6): e14364, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30732169

RESUMO

Several approved inactivated hepatitis A (HA) vaccines are available in Korea. These have been shown to be immunogenic and safe in European children; however, their immunogenicity and safety have not been investigated among Korean children. We aimed to compare the immunogenicity and safety of the most commonly used HA vaccines in ethnic Korean children aged 12 to 18 months.In this open-label, randomized, prospective, multicenter study, 108 children were enrolled and randomized to receive a pediatric form of Avaxim, Epaxal, or Havrix. The 2nd dose was administered after an interval of 6 months. Anti-HA virus (HAV) immunoglobulin (Ig) G was measured to assess geometric mean concentrations (GMCs) and seropositvity rates (≥20 mIU/mL anti-HAV IgG). To assess safety, local solicited adverse events (AEs), systemic solicited AEs, unsolicited AEs, and serious AEs (SAEs) were graded.Among the 108 participants enrolled, 37, 34, and 37 received Avaxim, Epaxal, and Havrix, respectively. After administration of 2 doses, the seropositivity rates in the Avaxim, Epaxal, and Havrix groups were all 100% (95% confidence intervals [CIs]: 99.0-100, 98.9-100, and 99.0-100, respectively; P < .001). The anti-HAV GMCs in the Avaxim, Epaxal, and Havrix groups were 5868.4 (95% CI: 4237.2-8126.6), 1962.1 (95% CI: 1298.0-2965.9), and 2232.9 mIU/mL (95% CI: 1428.4-3490.4), respectively, after administration of 2 doses (P < .001). There were no significant differences in the proportions of participants reporting local solicited AEs, systemic solicited AEs, unsolicited AEs, and SAEs among the 3 vaccine groups after the 1st and 2nd doses. All local solicited and unsolicited AEs were grade 1 or 2. Grade 3 systemic solicited AE occurred in 5.4% and 2.9% of the participants in the Havrix group after the 1st and 2nd doses, respectively. SAEs after the 1st and 2nd doses were reported in 2 participants and 1 participant, respectively, but none was assessed as being related to vaccination.The results indicate that these vaccines were safe and immunogenic in ethnic Korean children. The results have contributed to the establishing of an HA vaccination policy in Korea and will be informative to countries that plan to initiate vaccination programs against HAV.


Assuntos
Vacinas contra Hepatite A/efeitos adversos , Vacinas contra Hepatite A/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Feminino , Vacinas contra Hepatite A/administração & dosagem , Humanos , Lactente , Masculino , Estudos Prospectivos , República da Coreia , Vacinas de Produtos Inativados/administração & dosagem
12.
Hum Vaccin Immunother ; 15(5): 1048-1059, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30648923

RESUMO

Influenza is a major public health burden, mainly prevented by vaccination. Recommendations on influenza vaccine composition are updated annually and constant benefit-risk monitoring is therefore needed. We conducted near-real-time enhanced passive surveillance (EPS) for the influenza vaccine, Fluarix Tetra, according to European Medicines Agency guidance, in 10 volunteer general practices in England using Fluarix Tetra as their principal influenza vaccine brand, from 1-Sep to 30-Nov-2016. The EPS method used a combination of routinely collected data from electronic health records (EHR) and a customized adverse events reporting card (AERC) distributed to participants vaccinated with Fluarix Tetra. For participants vaccinated with a different influenza vaccine, data were derived exclusively from the EHR. We reported weekly and cumulative incidence of pre-defined adverse events of interest (AEI) occurring within 7 days post-vaccination, adjusted for clustering effect. Of the 97,754 eligible participants, 19,334 (19.8%) received influenza vaccination, of whom 13,861 (71.7%) received Fluarix Tetra. A total of 1,049 participants receiving Fluarix Tetra reported AEIs; 703 (67%) used the AERC (adjusted cumulative incidence rate 4.96% [95% CI: 3.92-6.25]). Analysis by individual pre-specified AEI categories identified no safety signal for Fluarix Tetra. A total of 62 individuals reported an AEI with a known brand of non-GSK influenza vaccine and 54 with an unknown brand (adjusted cumulative incidence rate 2.59% [1.93-3.47] and 1.77% [1.42-2.20], respectively). In conclusion, the study identified no safety signal for Fluarix Tetra and showed that the AERC was a useful tool that complemented routine pharmacovigilance by allowing more comprehensive capture of AEIs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Coleta de Dados , Registros Eletrônicos de Saúde , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Farmacovigilância , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
13.
Hum Vaccin Immunother ; 15(1): 107-108, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30118641

RESUMO

OBJECTIVE: We report a case of deafness occurring in a temporal context of an influenza vaccination in a 79-year-old woman. METHODS: Case report and review of the literature on influenza causing deafness. RESULTS: A 79-year-old woman with normal hearing developed acute bilateral sensorineural hearing loss two days after a seasonal influenza vaccination, other obvious reasons for acute hearing loss were excluded. CONCLUSION: This patient appears to be the first reported case of bilateral deafness following a trivalent seasonal influenza vaccination.


Assuntos
Perda Auditiva Bilateral/etiologia , Vacinas contra Influenza/efeitos adversos , Vacinação/efeitos adversos , Idoso , Feminino , Humanos , Influenza Humana/prevenção & controle , Vacinas de Produtos Inativados/efeitos adversos , Vertigem/virologia
14.
Hum Vaccin Immunother ; 15(3): 687-699, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30380986

RESUMO

Pregnant women are at increased risk of morbidity and mortality from influenza and are recognized as a priority group for influenza vaccination. Despite this, uptake is often poor and one reason cited for this is concerns about safety. The objective of this study was to perform a systematic review of the safety of inactivated influenza vaccination (IIV) in pregnancy. Studies were included if they were: (i) observational or experimental design; (ii) included a comparator group comprising of unvaccinated pregnant women; (iii) comprised of either seasonal IIV or monovalent H1N1 IIV (including adjuvanted vaccines); and (iv) addressed one of the following outcomes: preterm birth (PTB), small for gestational age (SGA), fetal death (including stillbirth or spontaneous abortion), low birth weight (LBW) or congenital abnormalities. Two reviewers screened abstracts and titles and selected full texts for retrieval. Crude odds ratios were calculated from reported event rates, using binomial standard errors. Adjusted odds ratios, hazard ratios and relative rates were extracted as reported in each paper. After removal of duplicates and full text eligibility assessment, 40 studies remained. The aOR for PTB was 0.87 (0.78-0.96), for LBW 0.82 (0.76-0.89), congenital abnormality 1.03 (0.99-1.07), SGA 0.99 (0.94-1.04) and stillbirth 0.84 (0.65-1.08). This study contributes to the increasing body of safety data for IIV in pregnancy and reports a protective effect on PTB and LBW.


Assuntos
Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação/efeitos adversos , Aborto Espontâneo/prevenção & controle , Aborto Espontâneo/virologia , Adulto , Feminino , Humanos , Recém-Nascido Pequeno para a Idade Gestacional , Vírus da Influenza A Subtipo H1N1 , Estudos Observacionais como Assunto , Razão de Chances , Gravidez , Nascimento Prematuro/prevenção & controle , Nascimento Prematuro/virologia , Natimorto , Vacinas de Produtos Inativados/efeitos adversos
15.
Vaccine ; 37(2): 343-351, 2019 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-30057283

RESUMO

BACKGROUND: In the Southern Hemisphere 2010 influenza season, Seqirus' split-virion, trivalent inactivated influenza vaccine was associated with increased reports of fevers and febrile reactions in young children. A staged clinical development program of a quadrivalent vaccine (Seqirus IIV4 [S-IIV4]; Afluria® Quadrivalent/Afluria Quad™/Afluria Tetra™), wherein each vaccine strain is split using a higher detergent concentration to reduce lipid content (considered the cause of the increased fevers and febrile reactions), is now complete. METHODS: Children aged 6-59 months were randomized 3:1 and stratified by age (6-35 months/36-59 months) to receive S-IIV4 (n = 1684) or a United States (US)-licensed comparator IIV4 (C-IIV4; Fluzone® Quadrivalent; n = 563) during the Northern Hemisphere 2016-2017 influenza season. The primary objective was to demonstrate noninferior immunogenicity of S-IIV4 versus C-IIV4. Immunogenicity was assessed by hemagglutination inhibition (baseline, 28 days postvaccination). Solicited, unsolicited, and serious adverse events were assessed for 7, 28, and 180 days postvaccination, respectively. RESULTS: S-IIV4 met the immunogenicity criteria for noninferiority. Adjusted geometric mean titer ratios (C-IIV4/S-IIV4) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 0.79 (95% CI: 0.72, 0.88), 1.27 (1.15, 1.42), 1.12 (1.01, 1.24), and 0.97 (0.86, 1.09), respectively. Corresponding values for differences in seroconversion rates (C-IIV4 minus S-IIV4) were -10.3 (-15.4, -5.1), 2.6 (-2.5, 7.8), 3.1 (-2.1, 8.2), and 0.9 (-4.2, 6.1). Solicited, unsolicited, and serious adverse events were similar between vaccines in both age cohorts, apart from fever. Fever rates were lower with S-IIV4 (5.8%) than C-IIV4 (8.4%), with no febrile convulsions reported with either vaccine during the 7 days postvaccination. CONCLUSION: S-IIV4, manufactured with a higher detergent concentration, demonstrated noninferior immunogenicity to the US-licensed C-IIV4, with similar postvaccination safety and tolerability, in children aged 6-59 months. This completes the program demonstrating the immunogenicity and safety of S-IIV4 in participants aged 6 months and older. FUNDING: Seqirus Pty Ltd; ClinicalTrials.gov identifier:NCT02914275.


Assuntos
Anticorpos Antivirais/sangue , Imunogenicidade da Vacina , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Pré-Escolar , Método Duplo-Cego , Feminino , Febre/induzido quimicamente , Humanos , Lactente , Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H3N2/imunologia , Vírus da Influenza B/imunologia , Vacinas contra Influenza/efeitos adversos , Masculino , Convulsões Febris/induzido quimicamente , Soroconversão , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia
16.
Hum Vaccin Immunother ; 15(3): 748-754, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30403910

RESUMO

Hepatitis A is a vaccine-preventable infection caused by the HA virus (HAV) with transitional to intermediate endemicity in China. An inactivated vaccine first licensed in China in 2010 (Avaxim® 80U Pediatric) is indicated for primary and booster vaccination in children from 12 months to 15 years of age. This Phase IV, open-label, single-arm trial supported licensure in pediatric age groups in China. A total of 355 healthy infants and toddlers (< 2 years of age), children (2 to 11 years of age), and adolescents (≥ 12 years of age) were enrolled to receive two doses of intramuscular HA vaccine, separated by 6 months. Participants were split into Group 1 (infants and toddlers: N = 270) and Group 2 (children and adolescents: N = 85). Safety was assessed by solicited injection site and systemic adverse events (AEs) for 7 days and unsolicited AEs for 30 days after each vaccination. Serious AEs (SAEs) were collected throughout. Immunogenicity was not assessed. Analyses were descriptive. Both vaccinations were very well tolerated in each group. The incidence of solicited injection site reactions was lower in Group 1 (17.9%) than Group 2 (33.3%) and for solicited systemic reactions was similar for each group. The incidence of unsolicited AEs in Group 1 was 6.3% and none in Group 2. For solicited and unsolicited AEs the incidence was slightly higher after the first vaccination. There were no SAEs. Overall, the good safety profile of this pediatric HA vaccine was confirmed in infants, toddlers, children, and adolescents aged 12 months to 15 years in China.


Assuntos
Vacinas contra Hepatite A/administração & dosagem , Hepatite A/prevenção & controle , Esquemas de Imunização , Adolescente , Criança , Pré-Escolar , China , Feminino , Vacinas contra Hepatite A/efeitos adversos , Humanos , Imunização Secundária , Lactente , Injeções Intramusculares , Masculino , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
17.
Vaccine ; 37(2): 366-371, 2019 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-30503656

RESUMO

Vaccine adverse events and controversial safety issues have occurred in recent decades in Japan: aseptic meningitis following the measles-mumps-rubella combined vaccine (MMR), anaphylaxis after immunization with live virus vaccines and inactivated split influenza vaccine, an increased incidence of febrile illness following the simultaneous administration of inactivated vaccines, and chronic pain with neurological illness after immunization with the human papilloma virus vaccine (HPV). Vaccine adverse events are a matter of concern for the public as well as general practitioners; some are within the range of assumptions that adverse reactions after live attenuated vaccines are related to the nature of their parental wild-type viruses. Vaccines stimulate the innate immunity of host immunological defense mechanisms and induce the development of specific acquired immunity. Some adverse events related to autoimmune responses have been reported, such as idiopathic thrombocytopenic purpura and acute disseminated encephalomyelitis (ADEM). Although a plausible relationship was not demonstrated, the possibility of an association cannot be denied. The pathogenicity of adverse reactions was investigated for anaphylactic reactions, systemic and local reactions following vaccinations. Initial innate immune responses are essential for the development of acquired immunity and are related to adverse events from different viewpoints.


Assuntos
Vacinação/efeitos adversos , Vacinas/efeitos adversos , Vacinas/imunologia , Animais , Humanos , Lactente , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Vacina contra Sarampo/efeitos adversos , Vacina contra Sarampo/imunologia , Vacina contra Sarampo-Caxumba-Rubéola/efeitos adversos , Vacina contra Sarampo-Caxumba-Rubéola/imunologia , Camundongos , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/imunologia , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia
18.
Zhonghua Liu Xing Bing Xue Za Zhi ; 39(12): 1636-1641, 2018 Dec 10.
Artigo em Chinês | MEDLINE | ID: mdl-30572392

RESUMO

Objective: To evaluate the immunogenicity of inactivated quadrivalent influenza vaccine (QIV) in adults aged 18-64 years, through a Meta-analysis. Methods: Literature was retrieved by searching the Medline, Cochrane Library, Science Direct in the past decade. All the studies were under random control trial (RCT) and including data related to immunogenicity which involving sero-protection rate (SPR) and sero-conversion rate (SCR) of the QIV, versus inactivated trivalent influenza vaccine (TIV) in the population aged 18 to 64. Revman 5.3 software was employed to manipulate the pooled date of the included literature. Result: A total of 8 studies for the SPR and SCR of the shared strains (two A lineage and one B lineage) were included. There appeared no significant differences in the response rates between the two vaccines. As for QIV versus TIV (B/Yamagata), the pooled RR of the SPR for B/Victoria was 1.28 (95%CI: 1.08-1.51, P<0.05), with the pooled RR of the SCR for B/Victoria as 1.94 (95%CI: 1.50-2.50, P<0.05). For QIV versus TIV (B/Victoria), the pooled RR of the SPR for B/Yamagata as 1.10 (95%CI: 1.02-1.18, P<0.05), and the pooled RR of SCR for B/Yamagata as 1.99 (95%CI: 1.34-2.97, P<0.05). Conclusion: In the population aged 18-64 years, inactivated QIV was equivalently immunogenic against the shared three strains included in the activated TIV while a superior immunogenic effect was noticed in the vaccine strain which did not include the inactivated QIV.


Assuntos
Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Influenza Humana/imunologia , Influenza Humana/prevenção & controle , Vacinas de Produtos Inativados/imunologia , Adolescente , Adulto , Anticorpos Antivirais/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Testes de Inibição da Hemaglutinação , Humanos , Vírus da Influenza A/imunologia , Vírus da Influenza B/imunologia , Vacinas contra Influenza/administração & dosagem , Pessoa de Meia-Idade , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
19.
Elife ; 72018 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-30592459

RESUMO

Pneumococcal whole cell vaccines (WCVs) could cost-effectively protect against a greater strain diversity than current capsule-based vaccines. Immunoglobulin G (IgG) responses to a WCV were characterised by applying longitudinally-sampled sera, available from 35 adult placebo-controlled phase I trial participants, to a panproteome microarray. Despite individuals maintaining distinctive antibody 'fingerprints', responses were consistent across vaccinated cohorts. Seventy-two functionally distinct proteins were associated with WCV-induced increases in IgG binding. These shared characteristics with naturally immunogenic proteins, being enriched for transporters and cell wall metabolism enzymes, likely unusually exposed on the unencapsulated WCV's surface. Vaccine-induced responses were specific to variants of the diverse PclA, PspC and ZmpB proteins, whereas PspA- and ZmpA-induced antibodies recognised a broader set of alleles. Temporal variation in IgG levels suggested a mixture of anamnestic and novel responses. These reproducible increases in IgG binding to a limited, but functionally diverse, set of conserved proteins indicate WCV could provide species-wide immunity.Clinical trial registration: The trial was registered with ClinicalTrials.gov with Identifier NCT01537185; the results are available from https://clinicaltrials.gov/ct2/show/results/NCT01537185.


Assuntos
Anticorpos Antibacterianos/sangue , Formação de Anticorpos , Vacinas Pneumocócicas/imunologia , Proteoma/análise , Vacinas de Produtos Inativados/imunologia , Adjuvantes Imunológicos/administração & dosagem , Adulto , Hidróxido de Alumínio/administração & dosagem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Voluntários Saudáveis , Humanos , Imunoglobulina G/sangue , Estudos Longitudinais , Placebos/administração & dosagem , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Análise Serial de Proteínas , Fatores de Tempo , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Adulto Jovem
20.
Vaccine ; 36(52): 8054-8061, 2018 12 18.
Artigo em Inglês | MEDLINE | ID: mdl-30416018

RESUMO

BACKGROUND: In the United States, seasonal inactivated influenza vaccine (IIV) is recommended for pregnant women; however, in early 2009, immunization rates were low, partly due to limited prospective data and concerns about vaccine safety. OBJECTIVE: We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women. STUDY DESIGN: In this prospective, randomized clinical study, 100 pregnant women, 18-39 years of age and ≥14 weeks gestation received a single intramuscular dose of 2008-2009 Fluzone® or Fluarix®. Injection site and systemic reactions were recorded for 7 days after vaccination and serious adverse events (SAEs) and pregnancy outcomes were documented. Serum samples collected before and 28 days after vaccination were tested for hemagglutination inhibition (HAI) antibody levels. RESULTS: The majority of the injection site and systemic reactions were mild and self-limited after both vaccines. No fever ≥100 °F was reported. There were no vaccine-associated SAEs. Immune responses to influenza vaccine antigens were similar for the two study vaccines, with robust HAI responses against influenza A strains, and relatively lower responses for influenza B strains. CONCLUSION: Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women. SYNOPSIS: In this prospective clinical trial, we demonstrated that immunization with seasonal trivalent, inactivated influenza vaccine in the second and third trimester of pregnancy is immunogenic and safe.


Assuntos
Anticorpos Antivirais/sangue , Imunogenicidade da Vacina , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Adolescente , Adulto , Feminino , Humanos , Influenza Humana/imunologia , Gravidez , Estudos Prospectivos , Estações do Ano , Estados Unidos , Vacinação , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
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