RESUMO
BACKGROUND: The coronavirus disease-2019 (COVID-19) pandemic has contributed to the change in the epidemiology of many infectious diseases. This study aimed to establish the pre-pandemic epidemiology of pediatric invasive bacterial infection (IBI). METHODS: A retrospective multicenter-based surveillance for pediatric IBIs has been maintained from 1996 to 2020 in Korea. IBIs caused by eight bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Listeria monocytogenes, and Salmonella species) in immunocompetent children > 3 months of age were collected at 29 centers. The annual trend in the proportion of IBIs by each pathogen was analyzed. RESULTS: A total of 2,195 episodes were identified during the 25-year period between 1996 and 2020. S. pneumoniae (42.4%), S. aureus (22.1%), and Salmonella species (21.0%) were common in children 3 to 59 months of age. In children ≥ 5 years of age, S. aureus (58.1%), followed by Salmonella species (14.8%) and S. pneumoniae (12.2%) were common. Excluding the year 2020, there was a trend toward a decrease in the relative proportions of S. pneumoniae (rs = -0.430, P = 0.036), H. influenzae (rs = -0.922, P < 0.001), while trend toward an increase in the relative proportion of S. aureus (rs = 0.850, P < 0.001), S. agalactiae (rs = 0.615, P = 0.001), and S. pyogenes (rs = 0.554, P = 0.005). CONCLUSION: In the proportion of IBIs over a 24-year period between 1996 and 2019, we observed a decreasing trend for S. pneumoniae and H. influenzae and an increasing trend for S. aureus, S. agalactiae, and S. pyogenes in children > 3 months of age. These findings can be used as the baseline data to navigate the trend in the epidemiology of pediatric IBI in the post COVID-19 era.
Assuntos
Infecções Bacterianas , COVID-19 , Meningites Bacterianas , Criança , Humanos , Lactente , Meningites Bacterianas/epidemiologia , Meningites Bacterianas/microbiologia , Staphylococcus aureus , Infecções Bacterianas/microbiologia , Bactérias , Streptococcus pneumoniae , Haemophilus influenzae , República da CoreiaRESUMO
BACKGROUND: Although the combination tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is recommended at adolescence in developed countries, the tetanus and diphtheria toxoid vaccine (Td), which is less costly, is recommended instead in some parts of the world. A new Td, BR-TD-1001, was developed by a Korean manufacturer for distribution to endemic regions and for use in the initial step of novel Tdap development. METHODS: This phase 3, randomized, double-blind, multi-center trial, conducted in Korea, aimed to evaluate the immunogenicity and safety of BR-TD-1001. Healthy children aged 10 to 12 years were randomized 1:1 to receive either BR-TD-1001 or the control Td (Td-pur, GlaxoSmithKline). Antibodies were measured using enzyme-linked immunosorbent assay. RESULTS: A total of 218 subjects (BR-TD-1001, n = 108; control, n = 110) were enrolled and included in the safety analysis. Vaccine-mediated antibody responses were similar in both groups. We confirmed the non-inferiority of BR-TD-1001 against the control, Td; 100% of both groups achieved seroprotection against diphtheria and tetanus. Furthermore, there was no significant difference between groups in the proportion of participants who demonstrated boost responses against diphtheria and tetanus toxoids. The incidence of solicited local and systemic adverse events (AEs), unsolicited AEs, and serious AEs did not differ significantly between groups. CONCLUSION: The BR-TD-1001 satisfied the immunological non-inferiority criterion against diphtheria and tetanus, with a clinically acceptable safety profile. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04618939.
Assuntos
Vacina contra Difteria e Tétano/imunologia , Difteria/prevenção & controle , Tétano/prevenção & controle , Anticorpos Antibacterianos/sangue , Formação de Anticorpos , Criança , Difteria/imunologia , Vacina contra Difteria e Tétano/administração & dosagem , Vacina contra Difteria e Tétano/efeitos adversos , Método Duplo-Cego , Ensaio de Imunoadsorção Enzimática , Eritema/etiologia , Feminino , Humanos , Masculino , Dor/etiologia , Dor/patologia , República da Coreia , Tétano/imunologiaRESUMO
This corrects the article on e45 in vol. 33, PMID: 29349940.
RESUMO
BACKGROUND: The frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013-2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years. METHODS: A total of 528 subjects were randomized 4:1 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated. RESULTS: The proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control. CONCLUSION: The new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines (Registered at the ClinicalTrials.gov NCT02541253).
Assuntos
Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Vacinas de Produtos Inativados/imunologia , Adolescente , Anticorpos Antivirais/sangue , Formação de Anticorpos , Criança , Pré-Escolar , Método Duplo-Cego , Fadiga/etiologia , Feminino , Testes de Inibição da Hemaglutinação , 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 , Influenza Humana/imunologia , Masculino , Dor/etiologia , Vacinas de Produtos Inativados/efeitos adversosRESUMO
BACKGROUND: Invasive bacterial infections in apparently immunocompetent children were retrospectively analyzed to figure causative bacterial organisms in Korea. METHODS: A total of 947 cases from 25 university hospitals were identified from 2006 to 2010 as a continuance of a previous 10-year period study from 1996 to 2005. RESULTS: Escherichia coli (41.3%), Streptococcus agalactiae (27.7%), and Staphylococcus aureus (27.1%) were the most common pathogens in infants < 3 months of age. S. agalactiae was the most prevalent cause of meningitis and pneumonia and E. coli was the major cause of bacteremia without localizing signs in this group. In children 3 to 59 months of age, Streptococcus pneumoniae (54.2%), S. aureus (20.5%), and Salmonella spp. (14.4%) were the most common pathogens. S. pneumoniae was the leading cause of pneumonia (86.0%), meningitis (65.0%), and bacteremia without localizing signs (49.0%) in this group. In children ≥ 5 years of age, S. aureus (62.8%) was the predominant pathogen, followed by Salmonella species (12.4%) and S. pneumoniae (11.5%). Salmonella species (43.0%) was the most common cause of bacteremia without localizing signs in this group. The relative proportion of S. aureus increased significantly over the 15-year period (1996-2010) in children ≥ 3 months of age (P < 0.001), while that of Haemophilus influenzae decreased significantly in both < 3 months of age group (P = 0.036) and ≥ 3 months of age groups (P < 0.001). CONCLUSION: S. agalactiae, E. coli, S. pneumoniae, and S. aureus are common etiologic agents of invasive bacterial infections in Korean children.
Assuntos
Infecções Bacterianas/diagnóstico , Escherichia coli/isolamento & purificação , Staphylococcus aureus/isolamento & purificação , Streptococcus agalactiae/isolamento & purificação , Streptococcus pneumoniae/isolamento & purificação , Infecções Bacterianas/microbiologia , Pré-Escolar , Feminino , Hospitais Universitários , Humanos , Hospedeiro Imunocomprometido , Lactente , Masculino , República da Coreia , Estudos RetrospectivosRESUMO
BACKGROUND: This prospective study was performed to evaluate serotype distribution, multilocus sequence typing, and antibiotic susceptibility of Streptococcus pneumoniae identified in Korean children with acute otitis media (AOM) after the introduction of a 7-valent pneumococcal conjugate vaccine (PCV7). METHODS: Nasopharyngeal aspirates were collected from children diagnosed with AOM in seven hospitals in Korea. The bacteria identified in these samples and the serotypes, sequence types (STs), and antibiotic susceptibilities of S. pneumoniae isolates were evaluated. RESULTS: A total of 390 children were enrolled, and bacteria were identified in 376 (96.4%) children. S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis were identified in 155 (39.7%), 127 (32.6%) and 86 (22.1%) children, respectively. Serotype 19A (22.4%) was the most common S. pneumoniae serotype, with serogroups 11 (14.7%) and 15 (13.5%) following. ST320 (23.5%) was the most common ST; ST166 (17.0%) and ST83 (8.5%) followed. The overall susceptibility rates of S. pneumoniae to oral penicillin V and amoxicillin/clavulanate were 2.6% and 53.2%, respectively. The susceptibility rate to cefditoren was 91.0%; however, the rates for other cephalosporins were less than 10.0%. Compared with other serogroups, S. pneumoniae serogroups 19, 11, and 15 showed significantly lower susceptibility rates to all the antibiotics tested. CONCLUSION: S. pneumoniae serotype 19A, serogroups 11 and 15 were the major nasopharyngeal-colonizing bacteria in Korean children with AOM after the introduction of PCV7. These relatively prevalent serotype/serogroups showed lower antibiotic susceptibility rates.
Assuntos
Doença Aguda/epidemiologia , Nasofaringe/microbiologia , Otite Média/microbiologia , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/microbiologia , Streptococcus pneumoniae/isolamento & purificação , Antibacterianos/imunologia , Criança , Pré-Escolar , Haemophilus influenzae/isolamento & purificação , Humanos , Lactente , Recém-Nascido , Testes de Sensibilidade Microbiana/métodos , Moraxella catarrhalis/isolamento & purificação , Nasofaringe/imunologia , Otite Média/imunologia , Infecções Pneumocócicas/imunologia , Vacinas Pneumocócicas/imunologia , Prevalência , Estudos Prospectivos , República da Coreia/epidemiologia , Sorogrupo , Sorotipagem/métodos , Streptococcus pneumoniae/imunologia , Vacinas Conjugadas/imunologiaRESUMO
This study was performed to measure early changes in the serotype distribution of pneumococci isolated from children with invasive disease during the 3-year period following the introduction of 10- and 13-valent pneumococcal conjugate vaccines (PCVs) in Korea. From January 2011 to December 2013 at 25 hospitals located throughout Korea, pneumococci were isolated among children who had invasive pneumococcal disease (IPD). Serotypes were determined using the Quellung reaction, and the change in serotype distribution was analyzed. Seventy-five cases of IPD were included. Eighty percent of patients were aged 3-59 months, and 32% had a comorbidity that increased the risk of pneumococcal infection. The most common serotypes were 19A (32.0%), 10A (8.0%), and 15C (6.7%). The PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, and 6A) accounted for 14.7% of the total isolates and the PCV13 minus PCV7 types (1, 3, 5, 7F and 19A) accounted for 32.0% of the total isolates. Serotype 19A was the only serotype in the PCV13 minus PCV7 group. The proportion of serotype 19A showed decreasing tendency from 37.5% in 2011 to 22.2% in 2013 (P = 0.309), while the proportion of non-PCV13 types showed increasing tendency from 45.8% in 2011 to 72.2% in 2013 (P = 0.108). Shortly after the introduction of extended-valent PCVs in Korea, serotype 19A continued to be the most common serotype causing IPD in children. Subsequently, the proportion of 19A decreased, and non-vaccine serotypes emerged as an important cause of IPD. The impact of extended-valent vaccines must be continuously monitored.
Assuntos
Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/imunologia , Streptococcus pneumoniae/classificação , Vacinas Conjugadas/imunologia , Adolescente , Bacteriemia/complicações , Bacteriemia/diagnóstico , Criança , Pré-Escolar , Feminino , Hospitais , Humanos , Lactente , Masculino , Infecções Pneumocócicas/microbiologia , República da Coreia , Sorotipagem , Streptococcus pneumoniae/isolamento & purificaçãoRESUMO
Rotavirus (RV) is one of the most important viral etiologic agents of acute gastroenteritis (AGE) in children. Although effective RV vaccines (RVVs) are now used worldwide, novel genotypes and outbreaks resulting from rare genotype combinations have emerged. This study documented RV genotypes in a Korean population of children with AGE 5 yr after the introduction of RVV and assessed potential genotype differences based on vaccination status or vaccine type. Children less than 5-yr-old diagnosed with AGE between October 2012 and September 2013 admitted to 9 medical institutions from 8 provinces in Korea were prospectively enrolled. Stool samples were tested for RV by enzyme immunoassay and genotyped by multiplex reverse-transcription polymerase chain reaction. In 346 patients, 114 (32.9%) were RV-positive. Among them, 87 (76.3%) patients were infected with RV alone. Eighty-six of 114 RV-positive stool samples were successfully genotyped, and their combinations of genotypes were G1P[8] (36, 41.9%), G2P[4] (12, 14.0%), and G3P[8] (6, 7.0%). RV was detected in 27.8% of patients in the vaccinated group and 39.8% in the unvaccinated group (P=0.035). Vaccination history was available for 67 of 86 cases with successfully genotyped RV-positive stool samples; RotaTeq (20, 29.9%), Rotarix (7, 10.4%), unvaccinated (40, 59.7%). The incidence of RV AGE is lower in the RV-vaccinated group compared to the unvaccinated group with no evidence of substitution with unusual genotype combinations.
Assuntos
Vacinação em Massa , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/imunologia , Rotavirus/classificação , Rotavirus/genética , Pré-Escolar , Fezes/virologia , Gastroenterite/imunologia , Gastroenterite/prevenção & controle , Gastroenterite/virologia , Genótipo , Humanos , Lactente , RNA Viral/genética , República da Coreia , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Rotavirus/isolamento & purificação , Infecções por Rotavirus/imunologia , Infecções por Rotavirus/virologia , Vacinas Atenuadas/imunologiaRESUMO
This seroepidemiologic study was performed to evaluate the immune status against tetanus in Korean adolescents and adults and to provide evidence to develop strategies for tetanus prevention. Between July 2012 and December 2012, serum samples were collected from adults and adolescents 11 years of age and older, and serum anti-tetanus IgG titers were determined using a commercial ELISA kit. Subjects were divided into six age groups: 11-20 years, 21-30 years, 31-40 years, 41-50 years, 51-60 years, and ≥61 years. The mean anti-tetanus IgG titers and tetanus seroprevalence of the age groups were compared. A total of 1193 adults and adolescents were enrolled. Mean anti-tetanus IgG titer and tetanus seroprevalence of all subjects were 1.20 ± 3.58 IU/mL and 56.4%, respectively. The mean anti-tetanus IgG titer decreased with an increase in age (p < 0.001). Tetanus seroprevalence increased from 92.0% in the 11-20 year age group to 95.7% in the 21-30 year age group, and then decreased with a further increase in age (p < 0.001). These results reflected an appropriate Td booster vaccine coverage at 11-12 years of age. However, the tetanus seroprevalence of adults older than 41 years was as low as the levels in previous studies: therefore, adults should be more encouraged to acquire decennial Td booster vaccinations recommended by the National Immunization Program.
Assuntos
Tétano/epidemiologia , Adolescente , Adulto , Anticorpos Antibacterianos/sangue , Anticorpos Antibacterianos/imunologia , Criança , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Masculino , Pessoa de Meia-Idade , República da Coreia/epidemiologia , Estudos Soroepidemiológicos , Tétano/sangue , Tétano/imunologia , Tétano/prevenção & controle , Adulto JovemRESUMO
This study was conducted to evaluate age-specific seroprevalence of pertussis in Korea and to formulate a strategy to prevent and reduce the incidence of pertussis. Residual serum samples of healthy adolescents and adults 11 yr of age or older were collected between July 2012 and December 2012, and anti-pertussis toxin (PT) IgG titers were measured using a commercial ELISA kit. We compared the mean anti-PT IgG titers and seroprevalence of pertussis of the six age groups: 11-20, 21-30, 31-40, 41-50, 51-60, and ≥ 61 yr. A total of 1,192 subjects were enrolled. The mean anti-PT IgG titer and pertussis seroprevalence were 35.53 ± 62.91 EU/mL and 41.4%, respectively. The mean anti-PT IgG titers and seroprevalence were not significantly different between the age groups. However, the seroprevalence in individuals 51 yr of age or older was significantly higher than in individuals younger than 51 yr (46.5% vs 39.1%, P = 0.017). Based on these results, a new pertussis prevention strategy is necessary for older adults.
Assuntos
Anticorpos Antibacterianos/sangue , Bordetella pertussis/imunologia , Imunoglobulina G/sangue , Toxina Pertussis/imunologia , Coqueluche/epidemiologia , Adolescente , Adulto , Envelhecimento , Criança , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Imunoglobulina G/imunologia , Incidência , Masculino , Pessoa de Meia-Idade , Toxina Pertussis/sangue , Vacina contra Coqueluche/imunologia , República da Coreia/epidemiologia , Estudos Soroepidemiológicos , Vacinação , Coqueluche/sangue , Adulto JovemRESUMO
UNLABELLED: Rotavirus gastroenteritis is the leading cause of severe acute gastroenteritis in children worldwide and is associated with high hospitalization and mortality rates in children younger than 5 years of age. Vaccination is necessary to prevent rotavirus infection. Two live attenuated and orally administered rotavirus vaccines became commercially available in Korea. The aim of this study is to describe epidemiological changes in rotavirus gastroenteritis after the introduction of rotavirus vaccines in Korea. The medical records of 11,199 children younger than 5 years of age and hospitalized for acute gastroenteritis from August 2007 to July 2010 in eight Korean hospitals were reviewed. Rotavirus was detected in stool samples obtained from 2,959 children (26.42 %). The authors evaluated the percentage of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in eight hospitals located in different geographical areas and analyzed epidemiological changes in rotavirus gastroenteritis according to age, geographical area, and season. According to the findings, the percentage of rotavirus gastroenteritis showed a decrease in children eligible for vaccination during the study period. After introduction of the vaccine, reduced rates of rotavirus detection were observed in all of the geographical areas, and the greatest reduction was observed in Seoul. In Seoul, there was a marked delay of the rotavirus season. CONCLUSION: Epidemiologic changes in Korea after the introduction of rotavirus vaccine are consistent with changes observed in other countries.
Assuntos
Gastroenterite/epidemiologia , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus , Fatores Etários , Pré-Escolar , Feminino , Gastroenterite/virologia , Hospitalização/estatística & dados numéricos , Humanos , Lactente , Masculino , República da Coreia/epidemiologia , Estudos Retrospectivos , Infecções por Rotavirus/prevenção & controle , Estações do AnoRESUMO
This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (≥ 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, the geometric mean titer (GMT) against diphtheria was significantly higher in Group GC1107-T5.0 (6.53) and GC1107-T7.5 (6.11) than in the control group (3.96). The GMT against tetanus was 18.6 in Group GC1107-T5.0, 19.94 in GC1107-T7.5 and 19.01 in the control group after the vaccination. In this study, the rates of local adverse reactions were 67.3% and 59.1% in GC1107-T5.0 and GC1107-7.5, respectively. No significant differences in the number of adverse reactions, prevalence and degree of severity of the solicited and unsolicited adverse reactions were observed among the three groups. Thus, both newly developed Td vaccines appear to be safe and show good immunogenicity. GC1107-T5.0, which contains relatively small amounts of tetanus toxoid, has been selected for a phase III clinical trial.
Assuntos
Vacina contra Difteria e Tétano/imunologia , Difteria/prevenção & controle , Tétano/prevenção & controle , Anticorpos Antibacterianos/sangue , Artralgia/etiologia , Criança , Vacina contra Difteria e Tétano/efeitos adversos , Método Duplo-Cego , Feminino , Cefaleia/etiologia , Humanos , Masculino , Dor/etiologia , Resultado do Tratamento , VacinaçãoRESUMO
Korean manufacturers have developed a new varicella vaccine, NBP608. This phase 3, randomized, double-blind, multicenter study aimed to compare the immunogenicity and safety of NBP608 in healthy children to those of VarivaxTM (control). Children aged 12 months to 12 years were randomized in a ratio of 1:1 to receive either NBP608 or the control vaccine. Serum samples were obtained before vaccination and within six to eight weeks after vaccination. In total, 499 participants (NBP608, n = 251; control, n = 248) were enrolled. The seroconversion rate (SCR) measured using a FAMA assay was 99.53% in the NBP608 group, and the lower limit of the 95% confidence interval (95% LCL) for the SCR difference (NBP608 minus the control) was 0.52%. This 95% LCL for the difference was higher than the specified non-inferiority margin of -15%. In an assessment using gpELISA, the SCR was 99.53% in the NBP608 group, and the 95% LCL for the SCR difference was 6.5%, which was higher than the specified non-inferiority margin of -15%. There were no significant differences between the NBP608 and control group with respect to the proportions of participants who demonstrated local and systemic solicited AEs. This study indicated that NBP608 had a clinically acceptable safety profile and was not immunologically inferior to VarivaxTM.
RESUMO
OBJECTIVES: Invasive bacterial infection (IBI) causes a significant burden in infants. In this study, we analyzed changes in epidemiology of IBI among infants in Korea. METHODS: A retrospective multicenter-based surveillance for IBIs in infants <3 months of age was performed during 2006-2020. Cases were classified as an early-onset disease (EOD) (0-6 days) or late-onset disease (LOD) (7-89 days). The temporal trend change in proportion of pathogens was analyzed. RESULTS: Among 1545 cases, the median age was 28 days (IQR: 12, 53) and EOD accounted for 17.7%. Among pathogens, S. agalactiae (40.4%), E. coli (38.5%), and S. aureus (17.8%) were the most common and attributed for 96.7%. Among EOD (n = 274), S. agalactiae (45.6%), S. aureus (31.4%), E. coli (17.2%) and L. monocytogenes (2.9%) were most common. Among LOD (n = 1274), E. coli (43.1%), S. agalactiae (39.3%), S. aureus (14.9%) and S. pneumoniae (1.3%) were most common. In the trend analysis, the proportion of S. aureus (r s = -0.850, P < 0.01) decreased significantly, while that of S. agalactiae increased (r s = 0.781, P < 0.01). CONCLUSION: During 2006-2020, among IBI in infants <3 months of age, S. agalactiae, E. coli, and S. aureus were most common and an increasing trend of S. agalactiae was observed.
Assuntos
Infecções Bacterianas , Infecções Estreptocócicas , Lactente , Humanos , Adulto , Streptococcus agalactiae , Staphylococcus aureus , Escherichia coli , Infecções Bacterianas/epidemiologia , Infecções Bacterianas/microbiologia , Bactérias , Estudos Retrospectivos , Streptococcus pneumoniae , Infecções Estreptocócicas/epidemiologiaRESUMO
We report results of a randomized, double-blinded, active-controlled, phase III study conducted to evaluate the immunogenicity and safety of a new trivalent inactivated split-virus influenza vaccine (GC501) manufactured by the Green Cross Corporation in Korea. A total of 283 healthy children aged 6 months to < 18 yr were randomized to receive either GC501 or control. Of the GC501 recipients, seroconversion occurred in 48.5% for A/H1N1, 67.7% for A/H3N2 and 52% for influenza B. The proportion of subjects who had post-vaccination hemagglutination-inhibition titers of 1:40 or greater was 90.7% for A/H1N1, 86.8% for A/H3N2 and 82.4% for influenza B in the GC501 recipients. No serious adverse events related to vaccination, or withdrawals because of adverse events were reported. The majority of solicited adverse events were mild in intensity. GC501 vaccine has good tolerability and favorable immunogenicity in children aged 6 months to < 18 yr. The addition of one more brand of influenza vaccine may allow for better global accessibility of vaccine for epidemics or future pandemics.
Assuntos
Anticorpos Antivirais/sangue , Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H3N2/imunologia , Vírus da Influenza B/imunologia , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Adolescente , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Lactente , Masculino , República da Coreia , Vacinação , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologiaRESUMO
This study aims to identify the clinical characteristics for diagnosing streptococcal pharyngitis. The correlation between eighteen clinical manifestations and rapid antigen detection test results was analyzed. Among 205 patients, five clinical manifestations, pharyngeal hemorrhage (odds ratio [OR] = 11.85), palatal hemorrhage (OR = 9.32), tonsillar swelling (OR = 4.37), rash (OR = 3.02), and enlarged cervical nodes (OR = 1.91), were significantly correlated with group A Streptococcus (GAS) pharyngitis. Traditional indicators such as fever, pharyngeal redness, acute onset, headache, rhinorrhea, cough, tonsillar exudate, and cervical tenderness were not statistically related to GAS pharyngitis. Therefore, physicians should be cautious in using these traditional indicators.
RESUMO
Immunization is the most effective preventive strategy against varicella. While the Oka strain is commonly used for varicella vaccination worldwide, Korea widely uses the MAV/06 strain. A new live attenuated MAV/06 strain varicella vaccine (MG1111), which uses the new cell line Medical Research Council-5 for better viral propagation, was developed. MG1111 was approved by Korean health authorities. Here, we report the results of phase III, randomized, double-blind, multicenter study conducted in Korea and Thailand, which compared the immunogenicity and safety profiles of MG1111 versus the control vaccine, VarivaxTM. In total, 515 healthy children (12 month-12 years) were randomized 1:1 to receive either the MG1111 or control vaccine (MG1111: 258, Control: 257). The seroconversion rate (SCR) and geometric mean titer (GMT) were measured using the fluorescent antibody to membrane antigen (FAMA) test. The MG1111 group achieved a SCR of 97.9% (95% CI: 95.2-99.3) after vaccination. The lower limit of 95% CI for SCR difference (MG1111-VarivaxTM) was -4.0%, which was higher than the specified non-inferiority margin of -10%. Further, the GMT of the MG1111 increased from 2.0 to 74.2 (95% CI: 65.0-84.8) and the lower limits of the 95% CI for post-vaccination GMT ratios (MG1111/VarivaxTM) were 0.55 higher than the specified parameter of 0.5. Therefore, the MG1111 group was not statistically inferior to the control vaccine group in terms of SCR and GMT. Furthermore, the MG1111 and control vaccine groups were not significantly different in the percentage of participants showing adverse events-solicited, local, or systemic during 43-day period of observation and serious adverse events during 6 month of observation. The present results indicate that MG1111was not immunologically inferior to VarivaxTM, and safety profiles of MG1111 are similar to those of VarivaxTM.
Assuntos
Vacina contra Varicela , Varicela , Anticorpos Antivirais , Vacina contra Varicela/efeitos adversos , Criança , Método Duplo-Cego , Humanos , Imunogenicidade da Vacina , República da Coreia , TailândiaRESUMO
The inactivated trivalent influenza vaccine (TIV) offers limited protection when two influenza B lineages co-circulate or when there is a vaccine mismatch (i.e., discordance in the predominant circulating B strain and WHO-recommended B strain). Inactivated quadrivalent influenza vaccine (QIV) may reduce the burden of influenza. Here, we report the results of a phase 3 clinical trial that evaluated the immunogenicity and safety of a novel QIV, GC3110A, in Korean children aged 6-35 months, which has been approved and is currently in use in Korea. The study involved two parts. In Part 1, the safety of GC3110A was evaluated in 10 subjects. After none of the subjects reported grade 3 adverse events (AEs), we proceeded to Part 2. Part 2 was a randomized, double-blind, multicenter phase 3 trial wherein we compared the immunogenicity and safety of GC3110A with those of a licensed control TIV. Immunogenicity was evaluated by measuring hemagglutination inhibition titers. The 200 participants enrolled in Part 2 were randomized in a 4:1 ratio to receive GC3110A or control TIV. The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) and secondary (i.e., the lower limit of 95% CI of the seroprotection rate exceeds 70% for four strains) immunogenicity endpoints. There was no significant between-group difference in the seroconversion rate, seroprotection rate, and geometric mean titer for the shared strains. However, the study vaccine group demonstrated significantly higher immunity for the additional strain B/Yamagata. In the safety analysis, there was no significant between-group difference in the proportion of participants with solicited local AEs, solicited systemic AEs, and unsolicited AEs. In conclusion, the results indicate that GC3110A has comparable immunogenicity and safety to those of TIV. Clinical Trial Registry Number: NCT03285997.
Assuntos
Vacinas contra Influenza , Influenza Humana , Anticorpos Antivirais , Criança , Pré-Escolar , Método Duplo-Cego , Testes de Inibição da Hemaglutinação , Humanos , Imunogenicidade da Vacina , Lactente , Vírus da Influenza B , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , República da Coreia , Vacinas de Produtos Inativados/efeitos adversos , VírionRESUMO
The enhanced inactivated poliovirus vaccine was first introduced in 2002, and several inactivated poliovirus vaccines are licensed in Korea. Reliable data by a prospective study on the immunogenicity and safety of the inactivated poliovirus vaccines in Korean infants are required. Normal healthy infants aged 6-12 weeks received three doses of the vaccine (IPVAX™, Imovax Polio™ or Poliorix™) in intervals of 2 months. Neutralizing antibody (NTAb) titers were measured before and 4-6 weeks after three-dose primary vaccination. Immunogenicity was evaluated by seroconversion rates and geometric mean titers obtained by analyzing NTAb titers. Local and systemic adverse events were recorded during 7 days after each vaccination. A total of 150 infants were included: 40 in IPVAX™, 52 in Imovax Polio™, and 58 in Poliorix™. The seroconversion rates for the group vaccinated with IPVAX™ were 100% in types 1, 2 and 3, while those of Imovax Polio™ were 98.1%, 96.2%, 96.2% and those of Poliorix™ were 98.3%, 100%, 100%, respectively. In all groups, injection site redness and irritability were the most common local and systemic adverse events. Neither serious adverse events nor adverse events above grade 2 were reported throughout the study. The currently used inactivated poliovirus vaccines was demonstrated to be safe and immunogenic in healthy Korean infants.