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1.
Bioanalysis ; 16(4): 191-201, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38315628

RESUMO

Monitoring serotype-specific IgG levels against pneumococci is crucial for assessing immunity, vaccine efficacy, and evaluating vaccination programs. The WHO ELISA for pneumococci is a standardized assay ensuring consistency in testing and comparability of results across laboratories. It involves a rigorous testing process to confirm accurate, precise and reliable detection of antibodies. We validated the protocol for 13 pneumococcal serotypes by assessing its specificity, reproducibility (coefficient of variation ≤15%), repeatability (coefficient of variation ≤20%), accuracy, lower limit of quantification, stability, and robustness. We found these parameters were within acceptable ranges and showed excellent performance. Our findings imply that the method employed is appropriate for evaluating 13 valent pneumococcal conjugate vaccine which is introduced in the national immunization program by comparing pre-and post-vaccination IgG response.


Assuntos
Anticorpos Antibacterianos , Streptococcus pneumoniae , Vacina Pneumocócica Conjugada Heptavalente , Reprodutibilidade dos Testes , Ensaio de Imunoadsorção Enzimática/métodos , Imunoglobulina G , Organização Mundial da Saúde
2.
Acta Paediatr ; 113(4): 764-770, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38217260

RESUMO

AIM: The pneumococcal conjugate vaccine, which covered seven serotypes of Streptococcus pneumoniae (PCV7), was introduced in Stockholm, Sweden, in 2007. It was replaced by a 13-valent vaccine (PCV13) in 2011. We previously reported a decreased incidence of pneumonia and sinusitis among young children 4 years after the introduction of the PCV7. This study followed the incidence of pneumonia, sinusitis, mastoiditis and meningitis for four more years. METHODS: We studied validated hospital registry data covering children up to 17 years of age, who were hospitalised in the Stockholm region from 2003 to 2016, when the child population peaked at 485 687. All 11 115 cases diagnosed with pneumonia, coded as bacterial pneumonia, sinusitis, mastoiditis, bacterial meningitis or empyema, were identified. The controls had viral pneumonia or pyelonephritis. RESULTS: The incidence rates for children under 2 years of age hospitalised for sinusitis, mastoiditis and meningitis decreased significantly by 61%-79% during the eight-year post-vaccination period. Hospitalisations for bacterial pneumonia decreased by 19%-25% in the same age group. These changes were probably due to both the vaccines and changes in diagnosis routines. CONCLUSION: The effect of vaccination on children under 2 years of age was sustained 8 years after the introduction of the pneumococcal conjugate vaccines.


Assuntos
Mastoidite , Meningite , Infecções Pneumocócicas , Pneumonia Bacteriana , Pneumonia Viral , Sinusite , Criança , Humanos , Lactente , Pré-Escolar , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas , Vacina Pneumocócica Conjugada Heptavalente , Vacinas Conjugadas , Suécia/epidemiologia , Mastoidite/epidemiologia
3.
Pediatrics ; 153(1)2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38087952

RESUMO

OBJECTIVES: We sought to describe the evolving epidemiology of invasive pneumococcal disease (IPD) among children in Massachusetts, United States, over the last 2 decades during which sequential 7-valent pneumococcal conjugate vaccines (PCV7) and 13-valent PCVs (PCV13) were implemented. METHODS: Cases of IPD in children aged <18 years were detected between 2002 and 2021 through an enhanced population-based, statewide surveillance system. Streptococcus pneumoniae isolates from normally sterile sites were serotyped and evaluated for antimicrobial susceptibility. IPD incidence rates and rate ratios with 95% confidence intervals (CIs) were calculated. RESULTS: We identified 1347 IPD cases. Incidence of IPD in children aged <18 years declined 72% over 2 decades between 2002 and 2021 (incidence rate ratios 0.28, 95% CI 0.18-0.45). IPD rates continued to decline after replacement of PCV7 with PCV13 (incidence rate ratios 0.25, 95% CI 0.16-0.39, late PCV7 era [2010] versus late PCV13 era [2021]). During the coronavirus disease 2019 pandemic years, 2020 to 2021, the rate of IPD among children aged <18 years reached 1.6 per 100 000, the lowest incidence observed over the 20 years. In PCV13 era, approximately one-third of the IPD cases in children aged >5 years had at least 1 underlying condition (98, 30.3%). Serotypes 19A and 7F contributed 342 (48.9%) of all cases before implementation of PCV13 (2002-2010). Serotype 3 (31, 8.6%), and non-PCV13 serotypes 15B/C (39, 10.8%), 33F (29, 8.0%), 23B (21, 0.8%), and 35B (17, 4.7%) were responsible for 37.8% of cases in PCV13 era (2011-2021). Penicillin nonsusceptibility continued to decline (9.8% vs 5.3% in pre-/late PCV13 era, P = .003), however has become more common among non-PCV13 serotypes compared with vaccine serotypes (14.8% vs 1.4%, P < .001). CONCLUSIONS: Robust ongoing surveillance networks are critical for identifying emerging serotypes and development of next-generation vaccine formulations.


Assuntos
Infecções Pneumocócicas , Criança , Humanos , Lactente , Vacinas Conjugadas , Vacina Pneumocócica Conjugada Heptavalente/uso terapêutico , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Streptococcus pneumoniae , Vacinas Pneumocócicas , Sorogrupo , Incidência
4.
Expert Rev Vaccines ; 23(1): 60-68, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38073483

RESUMO

BACKGROUND: Next-generation, higher-valency pneumococcal conjugate vaccines (PCVs), 15-valent PCV V114 and 20-valent PCV (PCV20), have been assessed by comparing their immune responses across serotypes shared with the 13-valent PCV (PCV13). Without efficacy or real-world vaccine effectiveness (VE) it becomes important to relate IgG titers to VE to aid in the interpretation of the immune response elicited by V114 and PCV20. METHODS: We estimated the protective antibody concentrations for each serotype in 7-valent PCV (PCV7) and PCV13 which were then used to predict the serotype-specific VE for each PCV7 and PCV13 non PCV7 serotype present in V114 and PCV20. RESULTS: The predicted effectiveness of V114 was comparable to PCV7 and PCV13 for 11 of the 13 shared serotypes (1, 4, 5, 6B, 7F, 9 V, 14, 18C, 19A, 19F, and 23F), with improved effectiveness against serotype 3 and decreased effectiveness against serotype 6A. PCV20 had predicted effectiveness comparable to PCV7 and PCV13 for 7 of the 13 shared serotypes (5, 6A, 7F, 9 V, 18C, 19F, and 23F), with decreased effectiveness against the remaining serotypes (1, 3, 4, 6B, 14, and 19A). CONCLUSIONS: Prediction of serotype-specific VE values suggests that V114 retains greater effectiveness than PCV20 toward most serotypes present in PCV7 and PCV13.


Pediatric pneumococcal conjugate vaccines (PCVs) first became available in 2000, when the seven-valent PCV (PCV7) was approved. Since then, PCV7 has been replaced by higher-valency vaccines, including the ten-valent (PCV10) and thirteen-valent (PCV13) vaccines and, more recently, fifteen- and twenty-valent vaccines (V114 and PCV20, respectively). The increase in valency provides broader serotype coverage against invasive pneumococcal disease (IPD) in children. However, IPD due to serotypes contained in PCV7 and PCV13 continue to be observed. In the current study, we used a previously published method to estimate the vaccine effectiveness of V114 and PCV20 in a US and Puerto Rican pediatric population that is recommended to receive a 3 + 1 dosing schedule.


Assuntos
Infecções Pneumocócicas , Vacinas Pneumocócicas , Criança , Humanos , Lactente , Sorogrupo , Vacina Pneumocócica Conjugada Heptavalente , Streptococcus pneumoniae , Infecções Pneumocócicas/prevenção & controle , Anticorpos Antibacterianos , Vacinas Conjugadas
5.
Blood Adv ; 7(21): 6751-6761, 2023 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-37698500

RESUMO

Children with sickle cell disease (SCD) are at increased risk of invasive pneumococcal disease (IPD). Over 25 years, the Georgia Emerging Infections Program/Centers for Disease Control and Prevention Active Bacterial Core Surveillance network identified 104 IPD episodes among 3707 children with hemoglobin SS (HbSS) or HbSC aged <10 years, representing 6% of IPD in Black or African American children residing in Metropolitan Atlanta (reference population). Children with IPD and HbSS/SC were older than those with IPD in the reference population (P < .001). From 1994-1999 to 2010-2018, IPD declined by 87% in children with HbSS aged 0 to 4 years, and by 80% in those aged 5 to 9 years. However, IPD incidence rate ratios when comparing children with SCD with the reference population increased from 20.2 to 29.2 over these periods. Among children with HbSS and IPD, death declined from 14% to 3% after 2002, and meningitis declined from 16% to 8%. Penicillin resistance was more prevalent in children with SCD before 7-valent pneumococcal conjugate vaccine (PCV7) licensure. After 2010, all IPD serotypes were not included in the 13-valent PCV (PCV13). Within 3 years of vaccination, the effectiveness of the 23-valent pneumococcal polysaccharide vaccine (PPSV23) against non-PCV13 serotypes included in PPSV23 plus 15A/15C was 92% (95% confidence interval, 40.8- 99.0, P = .014; indirect-cohort effect adjusted for age and hydroxyurea). PPSV23 would cover 62% of non-PCV13 serotype IPD in children with SCD, whereas PCV15, PCV20, and PCV21/V116 (in development) could cover 16%, 51%, and 92%, respectively. Although less frequent, IPD remains a life-threatening risk in children with SCD. Effective vaccines with broader coverage could benefit these children.


Assuntos
Anemia Falciforme , Infecções Pneumocócicas , Humanos , Criança , Vacina Pneumocócica Conjugada Heptavalente , Vacinas Conjugadas , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Infecções Pneumocócicas/microbiologia , Sorogrupo , Anemia Falciforme/complicações , Anemia Falciforme/epidemiologia , Hemoglobina Falciforme
6.
Vaccine ; 41(38): 5486-5489, 2023 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-37524629

RESUMO

In the province of Quebec, Canada, a 2 + 1 dose pneumococcal conjugate vaccine (PCV) program for children was implemented in 2004. PCV7 was replaced by PCV10 in 2009, by PCV13 in 2011 and by PCV10 in 2018, without catch-up in all instances. The objective was to estimate PCV13 effectiveness to prevent serotype 3 invasive pneumococcal disease in children aged less than 5 years, using 2010-2018 mandatory notification and laboratory surveillance data, an indirect cohort design and multivariate logistic regression models. A total of 29 cases of serotype 3 and 290 non-vaccine serotype cases as controls were analysed. Overall vaccine effectiveness (≥1 dose) was estimated at 59% [-39% to 88%]. During the first year after the last dose effectivness was 88% [47% to 97%] whereas no protection was observed thereafter. There was no trend towards increased effectiveness with the number of doses. PCV13 protection against serotype 3 IPD seems to be short-lived.


Assuntos
Infecções Pneumocócicas , Streptococcus pneumoniae , Humanos , Criança , Lactente , Quebeque/epidemiologia , Vacinas Conjugadas , Sorogrupo , Vacina Pneumocócica Conjugada Heptavalente , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas , Canadá
7.
Vaccine ; 41(29): 4313-4318, 2023 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-37286407

RESUMO

BACKGROUND: The pneumococcal conjugate vaccine (PCV) was introduced to children in Japan in February 2010 for PCV7 and February 2013 for PCV13. This study aimed to investigate the changes in child pneumonia hospitalization in Japan, before and after the introduction of PCV. METHODS: We utilized the JMDC Claims Database, an insurance claims database in Japan, with a cumulative population of approximately 10.6 million as of 2022. We extracted data of approximately 3.16 million children below 15 years of age from January 2006 to December 2019, and evaluated the number of pneumonia hospitalizations per 1,000 persons per year. The primary analysis was a comparison of three categories according to PCVs: before PCV7, before PCV13, and after PCV13 (2006-2009, 2010-2012, and 2013-2019). The secondary analysis was an interrupted time series (ITS) analysis, assessing the slope change in pneumonia hospitalizations per month, with PCV introduction as an intervening factor. RESULTS: The cases of pneumonia hospitalizations during the study period was 19,920 (0.6 %); 25 % of these were 0-1 years, 48 % were 2-4 years, 18 % were 5-9 years, and 9 % were 10-14 years. Pneumonia hospitalizations per 1000 population was 6.10 before PCV7 and 4.03 after PCV13, representing a 34 % decrease (p < 0.001). The reduction by age group was -30.1 % in 0-1 years, -20.3 % in 2-4 years, -41.7 % in 5-9 years, and -52.9 % in 10-14 years, significant reduction in all groups. ITS analysis showed a further reduction of -0.17 % per month after the introduction of PCV13 than that before PCV7 (p = 0.006). CONCLUSION: Our study estimated 4-6 pneumonia hospitalizations per 1000 pediatric population in Japan, with a 34 % decrease after the introduction of PCV. This study examined the nationwide effectiveness of PCV, further studies are needed in all age groups.


Assuntos
Infecções Pneumocócicas , Pneumonia , Criança , Humanos , Lactente , Recém-Nascido , Vacinas Pneumocócicas/uso terapêutico , Vacina Pneumocócica Conjugada Heptavalente/uso terapêutico , Vacinas Conjugadas/uso terapêutico , Japão/epidemiologia , Pneumonia/epidemiologia , Pneumonia/prevenção & controle , Hospitalização , Infecções Pneumocócicas/prevenção & controle , Incidência
8.
Euro Surveill ; 28(25)2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37347413

RESUMO

BackgroundPneumococcal conjugated vaccine (PCV)7 and PCV13 programmes started in Israel from July 2009 and November 2010 respectively, with a 2+1 schedule (one dose at 2 months old, one at 4 months old, and a booster dose at 12 months old). Thereafter, invasive pneumococcal disease (IPD) rates substantially declined in children. Uptake of all three doses in < 2-year-olds since 2012 is > 90%. For still incompletely vaccinated infants (≤ 12 months old), how well the PCV 2+1 programme shields from IPD is not fully resolved.AimTo assess the adequacy of protection conferred by the 2+1 schedule PCV vaccination programme, particularly among incompletely-vaccinated infants.MethodsThis was a population-based, prospective, nationwide active IPD surveillance study in Israel, 2004-2019, in children < 24 months old. We estimated annual incidence rates (IR) of overall IPD, IPD caused by PCV13 serotypes (VT13), and non-PCV13 serotypes (NVT13). Annual IPD IRs were stratified by age: < 4 months (receiving ≤ 1 dose), 4-6 months (immediately post dose 2), 7-12 months (a few months post dose 2), and 13-23 months (post dose 3). Late-PCV (2004-2008) to pre-PCV13 (2016-2019) mean annual IR ratios (IRRs) were calculated.Results2,569 IPD episodes were recorded. VT13 decreased > 90% in all age groups, while NVT13 seemed to increase. All-IPD rates declined in all age groups by 56-70%. The 2+1 schedule impact on 7-12-month-old infants (pre-booster) was similar to that on 13-23-month-old children (post booster), with PCV13 IPD reductions of 97% and 98%, respectively.ConclusionsIndirect (herd) protection of infants, including < 4 month-olds with ≤ 1 PCV dose, was achieved by the 2+1 PCV schedule programme which thus seems adequate.


Assuntos
Infecções Pneumocócicas , Vacinas Pneumocócicas , Criança , Pré-Escolar , Humanos , Lactente , Vacina Pneumocócica Conjugada Heptavalente , Incidência , Israel/epidemiologia , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/efeitos adversos , Estudos Prospectivos , Vacinas Conjugadas
9.
Pediatr Infect Dis J ; 42(8): 723-729, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37235761

RESUMO

BACKGROUND: We aim to estimate the magnitude of the reduction in pneumococcal pneumonia and meningitis mortality after the mass introduction of pneumococcal conjugate vaccine (PCV)7 and PCV13 in children in the United States. METHODS: We assessed the trends in mortality rates from pneumococcal pneumonia and meningitis, in the United States between 1994 and 2017. We fitted an interrupted time-series negative binomial regression model (adjusted by trend, seasonality, PCV7/PCV13 coverage, and H. influenzae type b vaccine coverage) to estimate the counterfactual rates without vaccination. We reported a percent reduction in mortality estimates relative to the projected no-vaccination scenario, using the formula 1 minus the incidence risk ratio, with 95% confidence intervals (CIs). RESULTS: Between 1994 and 1999 (the prevaccination period), the all-cause pneumonia mortality rate for 0-1-month-old children was 2.55 per 100,00 pop., whereas for 2-11 months-old children, this rate was 0.82 deaths per 100,000 pop. During the PCV7-period in 0-59-month-old children in the United States, the adjusted reduction of all-cause pneumonia was 13% (95% CI: 4-21) and 19% (95% CI: 0-33) of all-cause meningitis For PCV13, the reductions in this age group were 21% (95% CI: 4-35) for all-cause pneumonia mortality and 22% (95% CI: -19 to 48) for all-cause meningitis mortality. PCV13 had greater reductions of all-cause pneumonia than PCV13 in 6-11-month-old infants. CONCLUSIONS: The universal introduction of PCV7, and later PCV13, for children 0-59 months old in the United States was associated with decreases in mortality due to all-cause pneumonia.


Assuntos
Infecções Pneumocócicas , Pneumonia Pneumocócica , Criança , Lactente , Humanos , Estados Unidos/epidemiologia , Recém-Nascido , Pré-Escolar , Pneumonia Pneumocócica/epidemiologia , Pneumonia Pneumocócica/prevenção & controle , Infecções Pneumocócicas/epidemiologia , Vacinas Pneumocócicas , Vacina Pneumocócica Conjugada Heptavalente , Vacinação , Incidência , Vacinas Conjugadas
10.
Vaccine ; 41(5): 1142-1152, 2023 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-36621410

RESUMO

BACKGROUND: Pneumococcal disease (PD) remains a major health concern with considerable morbidity and mortality in children. Currently licensed pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and additional serotypes 22F and 33F. This pivotal phase 3 study compared safety and immunogenicity of V114 and PCV13. METHODS: 1720 healthy infants were randomized 1:1 to receive a 4-dose regimen of V114 or PCV13 concomitantly with other routine pediatric vaccines. Safety was evaluated after each dose as proportion of participants with adverse events (AEs). Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured at 1-month post-dose 3 (PD3), pre-dose 4, and 1-month post-dose 4 (PD4). IgG response rates, geometric mean concentrations (GMCs), and opsonophagocytic activity (OPA) were compared between vaccination groups. RESULTS: The proportion, maximum intensity, and duration of injection-site, systemic, and serious AEs were generally comparable between V114 and PCV13 groups. In comparison to PCV13, V114 met non-inferiority criteria for all 15 serotypes based on IgG response rates at PD3. V114 met non-inferiority criteria by IgG GMCs for all serotypes at PD3 and PD4, except for serotype 6A at PD3. V114-induced antibodies had bactericidal activity as assessed by OPA. Further, V114 met superiority criteria for shared serotype 3 and unique serotypes 22F and 33F compared to PCV13 by serotype-specific IgG GMCs at both PD3 and PD4. Immunogenicity of concomitantly administered routine pediatric vaccines was comparable in V114 and PCV13 groups. CONCLUSIONS: In healthy infants, V114 displays acceptable safety and tolerability profiles and generates comparable immune responses to PCV13. V114 also met superiority criteria for serotypes 3, 22F, and 33F. These results support use of V114 for prevention of PD as part of routine infant vaccination schedules. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03893448; EudraCT: 2018-004109-21.


Assuntos
Anticorpos Antibacterianos , Infecções Pneumocócicas , Humanos , Lactente , Criança , Vacinas Conjugadas , Imunoglobulina G , Streptococcus pneumoniae , Vacina Pneumocócica Conjugada Heptavalente , Vacinas Pneumocócicas , Método Duplo-Cego
11.
Med Microbiol Immunol ; 212(1): 93-102, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36595027

RESUMO

Measurement of anti-pneumococcal capsular polysaccharides (anti-PnPs) IgG titers is an important tool in the immunologic assessment of patients with suspected immunodeficiency disorders (ID) to reduce the morbi-mortality and minimize severe infections. Retrospectively, we studied the relationship among anti-PnPs IgG response to 3 doses of Prevenar®13, levels of immune system components, leukocyte populations, and clinical data in children with ID. Serum samples were collected at least 4 weeks post vaccination. Subsequently, multi-serotype enzyme-linked immunosorbent assay (ELISA) was performed. Eighty-seven children (under 12 years) were enrolled. Primary immunodeficiency disorder (PID) was the most common disorder (45) followed by possible immunodeficiency disorder (POID) (19), secondary immunodeficiency disorder (SID) (15), and mixed immunodeficiency disorder (MID) (8). The median age was 3 (1.50-5.33) years, 65% of patients were male. Deficient production of anti-PnPs IgG (titer ≤ 50 mg/L) was detected in 47 patients (54%), especially in the MID group, all of them under immunosuppressive therapy. In PCV13 responders, the mean of leukocyte population levels was higher with statistically significance differences in CD4 + /CD8 + T lymphocytes (p = 0.372, p = 0.014) and CD56 + /CD16 + NK (p = 0.016). Patients with previous bone marrow transplantation were the worst PCV13 responders. Pneumococcal IgG antibody titers (post-vaccination) along with clinical and analytical markers represented.


Assuntos
Formação de Anticorpos , Vacinas Pneumocócicas , Pré-Escolar , Feminino , Humanos , Masculino , Anticorpos Antibacterianos , Vacina Pneumocócica Conjugada Heptavalente , Imunoglobulina G , Estudos Retrospectivos , Streptococcus pneumoniae , Lactente
12.
Acta Clin Belg ; 78(1): 78-86, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35171752

RESUMO

OBJECTIVES: Currently existing pneumococcal vaccines have contributed to a major reduction in pneumococcal disease. However, there remains an unmet need for vaccine coverage of serotypes not included in PCV13 to further reduce the burden of disease. The objective of this review is to assess the potential impact of implementation of the investigational 20-valent pneumococcal conjugate vaccine (PCV20) in the childhood and adult immunization programme in Belgium and Europe. METHODS: A literature search was conducted to identify publications and surveillance reports concerning the effectiveness and safety of pneumococcal vaccines, epidemiological data on pneumococcal disease or serotype distribution dynamics after introduction of systematic vaccination. RESULTS: Serotypes included in PCV20 currently account for the majority of pneumococcal disease in Belgium and Europe. In Belgium, PCV20-serotypes accounted for 71.4% of invasive pneumococcal disease (IPD) cases across all age groups in 2019, of which 39.2% were caused by PCV20-non-PCV13-serotypes. In Europe, these seven serotypes accounted for 37,6% of IPD cases in 2018.  PCV20 has proven to be well tolerated in vaccine-naïve adults and elicits a substantial immune response against all serotypes included. CONCLUSION: Due to serotype replacement following the introduction of PCV7 and PCV13, a considerable proportion of pneumococcal disease is currently caused by PCV20-serotypes. PCV20 has the potential of preventing more pneumococcal disease in children and the adult population at risk than the existing conjugate vaccines. The available evidence on safety and immunogenicity of PCV20 is promising, but further research is needed to provide data about vaccine effectiveness, immune response duration and replacement phenomenon after introduction of PCV20.


Assuntos
Infecções Pneumocócicas , Streptococcus pneumoniae , Criança , Adulto , Humanos , Lactente , Vacina Pneumocócica Conjugada Heptavalente , Vacinas Conjugadas , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas
13.
Artigo em Inglês | MEDLINE | ID: mdl-35907773

RESUMO

OBJECTIVES: To study the spatio-temporal distribution of cases of invasive pneumococcal disease (IPD) due to serotypes resistant to erythromycin and its relationship with community consumption of macrolides and childhood vaccination coverage. METHODS: We selected IPD cases in adults over 59 years old, residents in the Community of Madrid (MC), notified in the period 2007-2016. The variables studied were obtained from the Vaccination Information Systems and the Pharmaceutical Service. The cut-off point (minimum inhibitory erythromycin concentration > 0.5 mg/L) of the EUCAST classification was used to define erythromycin resistant serotypes. We used JointPoint to estimate the incidence trends by erythromycin resistant serotypes included in the 13-valent vaccine (STPCV13) and not included in it (STnoPCV13). The association of these incidences with the community consumption of macrolides and vaccination coverage was made using Poisson models. Statistical scanning was used for the detection of temporal-spaces clusters of cases. RESULTS: 1936 cases were identified, of which 427 erythromycin resistant serotypes were identified. The incidence of all cases due to resistant serotypes was decreasing (AAPC: -5,40%). During the period studied, the incidence of cases due to erythromycin resistant STPCV13 was decreasing with an annual percentage change (APC): -13.8 and was inversely associated with childhood vaccination coverage (IRR 0.641), while that of cases due to erythromycin resistant STnoPCV13 was ascending (APC): 4.5; and was not associated with coverage. 1 cluster was detected by STnoPCV13 and none by STPCV13 after the date of inclusion of the 13-valent in the childhood vaccination calendar. CONCLUSIONS: The decrease in IPD due to resistant STPCV13 was associated with an increase in childhood vaccination coverage. The presence of clusters due to STnoPCV13 after the date of inclusion of the 13-valent vaccine in the childhood vaccination calendar indicates serotypes replacement. The increase in cases of resistant STnoPCV13 could be related to the replacement of vaccine serotypes in nasopharyngeal colonization, facilitated by the consumption of macrolides still at high levels in MC.


Assuntos
Infecções Pneumocócicas , Streptococcus pneumoniae , Adulto , Humanos , Pessoa de Meia-Idade , Sorogrupo , Vacinas Pneumocócicas , Vacina Pneumocócica Conjugada Heptavalente , Sorotipagem , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Antibacterianos/farmacologia , Eritromicina/farmacologia , Macrolídeos/farmacologia
14.
Expert Rev Vaccines ; 22(1): 118-138, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36565291

RESUMO

INTRODUCTION: Despite the introduction of effective pneumococcal conjugate vaccines (PCV), Streptococcus pneumoniae remains a major cause of acute otitis media (AOM) worldwide. New, higher valency vaccines that offer broader serotype coverage have been recently developed and others are in development. However, given the capsular serotypes expressed by pneumococci causing AOM, it is unclear to what extent differing or higher valency PCVs will provide additional protection. AREAS COVERED: We conducted a systematic literature search of the MEDLINE database to identify articles published from January 2016 to September 2021 in 4 low and middle income and 10 high-income countries. We searched PubMed with terms: (Streptococcus pneumoniae) OR pneumococcal AND serotype AND (conjugate vaccine). We evaluated serotype distribution and the actual or projected coverage of pneumococcal serotypes by PCV10 (GlaxoSmithKline), PCV13 (Pfizer), PCV10SII (Serum Institute of India) PCV15 (Merck) and PCV20 (Pfizer). EXPERT OPINION: Our review highlights the important epidemiological differences in serotype distribution and coverage by existing and higher valency vaccines to protect against AOM in children. These data provide support for further evaluation of serotype-independent vaccines for optimal control of pneumococcal AOM disease worldwide.


Assuntos
Otite Média , Infecções Pneumocócicas , Criança , Humanos , Lactente , Streptococcus pneumoniae , Sorogrupo , Vacinas Conjugadas , Vacina Pneumocócica Conjugada Heptavalente , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas , Otite Média/epidemiologia , Otite Média/prevenção & controle
15.
Vaccine ; 41(3): 657-665, 2023 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-36522265

RESUMO

BACKGROUND: Pneumococcal disease (PD) remains a major health concern globally. In children, pneumococcal conjugate vaccines (PCVs) provide protection against PD from most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and public health important serotypes 22F and 33F. This phase 3 study evaluated safety and immunogenicity of mixed PCV13/V114 regimens using a 3 + 1 dosing schedule when changing from PCV13 to V114 at doses 2, 3, or 4. METHODS: 900 healthy infants were randomized equally to 5 intervention groups. PCVs were administered in a 3-dose infant series at 2, 4, and 6 months of age followed by a toddler dose at 12-15 months along with concomitant routine vaccines. Safety was evaluated as the proportion of participants with adverse events (AEs). Immunoglobulin G (IgG) responses to the 15 serotypes in V114 were measured at 30 days post-dose 3 and 30 days post-dose 4 (PD4). RESULTS: Frequencies of injection-site and systemic AEs were generally comparable across all intervention groups. At 30 days PD4 (primary endpoint), IgG geometric mean concentrations (GMCs) for the 13 shared serotypes were generally comparable between mixed V114/PCV13 and 4-dose regimens of PCV13 or V114. In mixed regimens at 30 days PD4, a toddler dose of V114 was sufficient to achieve IgG GMCs comparable to a 4-dose regimen of V114 for serotype 22F, while at least one infant dose was needed in addition to the toddler dose to achieve IgG GMCs comparable to a 4-dose regimen of V114 for serotype 33F. CONCLUSIONS: V114 was well tolerated with a generally comparable safety profile to PCV13. For 13 shared serotypes, both mixed regimens and the V114 4-dose regimen induced generally comparable antibody responses to 4-dose regimen with PCV13. Study results support interchangeability of V114 with PCV13 in infants. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03620162; EudraCT: 2018-001151-12.


Assuntos
Infecções Pneumocócicas , Vacinas Pneumocócicas , Humanos , Lactente , Vacina Pneumocócica Conjugada Heptavalente , Vacinas Conjugadas , Método Duplo-Cego , Anticorpos Antibacterianos , Imunoglobulina G
16.
Vaccine ; 41(2): 452-459, 2023 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-36470684

RESUMO

AIM: Little data is available on pneumococcal serotypes and their antimicrobial resistance in the pneumococcal conjugate vaccination era in young children with acute otitis media (AOM). Here such data is provided from Slovakia, acountry with sequential introduction and parallel-use of the three commercially available pneumococcal conjugate vaccines (PCVs; PCV7; PCV13; PCV10). METHODS: This observational study takes advantage of the fact that tympanocentesis is the standard of care in children with AOM in Slovakia. Over the 12 year observation period, participating pediatric ENT specialists sent samples taken during tympanocentesis from children with AOM to their local MEDIRIX laboratories for identification of bacteria. Pneumcoccal isolates were serotyped and tested for antimicrobial resistance. Incidence data could be calculated from 1 region. RESULTS: Study participation and completeness of typing increased over time. Based on testing of 1,131 isolates over 12 years, PCV7-serotypes rapidly waned after PCV7 introduction in 2009 and had virtually disappeared in 2014. The maximum fraction of PCV10-only isolates (1, 5, 7F) was 2.7 % (2009) whereas the additional 3 PCV-serotypes (3, 6A, 19A) in PCV13 represented the largest proportion of pneumococcal AOM cases as of 2010. This finding remained unchanged during the period of highest PCV10-market share (2012-2017) and even until the end of the observation period (2019). The fraction of untypeable pneumococci (<6 %) and non-PCV13-serotypes (16-34 %) increased 2012-2017, but decreased again thereafter. Serotype 19A evolved as the most relevant (multidrug-) resistant pneumococcal serotype, again particularly during the time with high sales of PCV10 (2012-2017). Incidence data from the Bratislava region document a huge impact of PCV use (77 % vaccine uptake: mainly PCV13) on AOM in children < 6 years. Serotypes 19A and 3 remain the only relevant pneumococcal serotypes in young Slovakian children with AOM. CONCLUSIONS: As AOM is one of the most common bacterial infections in children < 6 years, the observed benefits of PCVs in reducing vaccine serotypes have been tremendous. With sequential / parallel-use of PCVs, serotypes 3 and (MDR-) 19A today make the largest proportion (about 2/3) of pneumococcal AOM in Slovakia. This data will help to further guide the choice of pneumococcal conjugate vaccines for pediatricians and parents.


Assuntos
Anti-Infecciosos , Otite Média , Infecções Pneumocócicas , Humanos , Criança , Lactente , Pré-Escolar , Streptococcus pneumoniae , Eslováquia/epidemiologia , Vacinas Conjugadas/uso terapêutico , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Infecções Pneumocócicas/microbiologia , Vacina Pneumocócica Conjugada Heptavalente/uso terapêutico , Vacinas Pneumocócicas , Otite Média/epidemiologia , Otite Média/prevenção & controle , Otite Média/microbiologia , Sorogrupo
17.
Expert Rev Vaccines ; 21(12): 1905-1921, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36342411

RESUMO

BACKGROUND: The impact of pneumococcal conjugate vaccines (PCVs) on the burden of invasive pneumococcal disease (IPD) and serotype distribution was examined across age groups from data collected by the Lebanese Inter-Hospital Pneumococcal Surveillance Program. METHODS: Between 2005 and 2020, 593 invasive Streptococcus pneumoniae isolates were collected from 79 hospitals throughout Lebanon. Serotypes and antimicrobial resistance (AMR) profiles were identified, and trends compared over 3 eras: PCV7, post-PCV7/ pre-PCV13, and PCV13 eras. RESULTS: The prevalence of PCV7 serotypes decreased significantly from 43.6% in the PCV7 era to 17.8% during the PCV13 era (p<0.001). PCV13-only serotypes remained stable in the PCV13 compared to the post-PCV7 eras, especially serotypes 1 and 3, whereas non-vaccine types (NVT) increased throughout the study period, especially 24 and 16F. The mortality rate increased substantially from 12.5% (PCV7 era) to 24.8% (PCV13 era). A significant decrease in AMR was observed across the three study eras. CONCLUSION: PCVs substantially impacted IPD and AMR in vaccinated and unvaccinated populations despite an increase in mortality driven by NVT. Broadening the recommendation of vaccination to include older age-groups, using higher valency vaccines, and implementing stringent antimicrobial stewardship are likely to further impact the burden of IPD.


Assuntos
Infecções Pneumocócicas , Humanos , Lactente , Sorogrupo , Vacina Pneumocócica Conjugada Heptavalente , Líbano/epidemiologia , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas , Streptococcus pneumoniae , Vacinas Conjugadas , Vacinação , Incidência
18.
BMC Public Health ; 22(1): 1677, 2022 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-36064378

RESUMO

BACKGROUND: Invasive pneumococcal disease (IPD) is a major cause of pediatric morbidity and mortality. Pneumococcal conjugate vaccines (PCVs) were introduced in the US in 2000 (PCV7) and 2010 (PCV13). This study estimated the annual incidence rates (IRs) and time trends of IPD to quantify the burden of disease in children before and after the introduction of PCV7 and PCV13 in the US. METHODS: IPD episodes were identified in the IBM MarketScan Commercial and Medicaid Databases using claims with International Classification of Diseases 9/10th Revision, Clinical Modification codes. Annual IRs were calculated as the number of IPD episodes/100,000 person-years (PYs) for children < 18 years and by age group (< 2, 2-4, and 5-17 years). National estimates of annual IPD IRs were extrapolated using Census Bureau data. Interrupted time series (ITS) analyses were conducted to assess immediate and gradual changes in IPD IRs before and after introduction of PCV7 and PCV13. RESULTS: In commercially insured children, IPD IRs decreased from 9.4 to 2.8 episodes/100,000 PY between the pre-PCV7 (1998-1999) and late PCV13 period (2014-2018) overall, and from 65.6 to 11.6 episodes/100,000 PY in children < 2 years. In the Medicaid population, IPD IRs decreased from 11.3 to 4.2 episodes/100,000 PY between the early PCV7 (2001-2005) and late PCV13 period overall, and from 42.6 to 12.8 episodes/100,000 PY in children < 2 years. The trends of IRs for meningitis, bacteremia, and bacteremic pneumonia followed the patterns of overall IPD episodes. The ITS analyses indicated significant decreases in the early PCV7 period, increases in the late PCV7 and decreases in the early PCV13 period in commercially insured children overall. However, increases were also observed in the late PCV13 period in children < 2 years. The percentage of cases with underlying risk factors increased in both populations. CONCLUSIONS: IRs of IPD decreased from 1998 to 2018, following introduction of PCV7 and PCV13, with larger declines during the early PCV7 and early PCV13 periods, and among younger children. However, the residual burden of IPD remains substantial. The impact of future PCVs on IPD IRs will depend on the proportion of vaccine-type serotypes and vaccine effectiveness in children with underlying conditions.


Assuntos
Bacteriemia , Seguro , Infecções Pneumocócicas , Bacteriemia/epidemiologia , Criança , Vacina Pneumocócica Conjugada Heptavalente , Humanos , Incidência , Lactente , Medicaid , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/uso terapêutico , Sorogrupo , Estados Unidos/epidemiologia , Vacinas Conjugadas
19.
Expert Rev Vaccines ; 21(10): 1515-1521, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35997125

RESUMO

BACKGROUND: The potential impact of new pneumococcal conjugate vaccines (PCVs) is assessed by using immune responses to predict their effectiveness against invasive pneumococcal disease (IPD). This analysis predicted the serotype-specific effectiveness against IPD of a new 15-valent PCV (V114) for the serotypes shared with a 13-valent PCV (PCV13), in a US pediatric population given a 3 + 1 dosing regimen. METHODS: Beginning with the known serotype-specific antibody concentrations after vaccination with placebo, 7-valent PCV (PCV7) and PCV13, reverse cumulative distribution curves were used, along with published serotype-specific vaccine effectiveness of PCV7 and PCV13, to derive a protective antibody concentration (Cp) for each PCV13 serotype in V114. Serotype-specific effectiveness was predicted using the Cp estimates and the respective serotype-specific antibody concentrations of placebo and V114 recipients in recent pediatric clinical trials. RESULTS: Predicted serotype-specific V114 effectiveness values ranged from 86% to 99% for PCV7 serotypes and from 59% to 97% for (non-PCV7) PCV13 serotypes. CONCLUSIONS: V114 serotype-specific effectiveness against IPD in a US pediatric population was predicted to be largely comparable to that of PCV7 and PCV13 for shared serotypes, with models suggesting likelihood of high overall benefit gained from increased serotype 3 effectiveness, and additional protection against serotypes 22 F and 33 F.


Assuntos
Infecções Pneumocócicas , Vacinas Pneumocócicas , Anticorpos , Criança , Vacina Pneumocócica Conjugada Heptavalente , Humanos , Lactente , Infecções Pneumocócicas/epidemiologia , Sorogrupo , Streptococcus pneumoniae , Vacinas Conjugadas
20.
Mikrobiyol Bul ; 56(3): 466-479, 2022 Jul.
Artigo em Turco | MEDLINE | ID: mdl-35960238

RESUMO

The aim of this single-center retrospective study was to determine the changes in the burden of allcause pneumonia, bacterial pneumonia and empyema in children aged 0-18 years after the availability of 7-valent pneumococcal conjugated vaccine (PCV7) and 13-valent pneumococcal conjugated vaccine (PCV13) in our country. Children aged 0-18 years who were hospitalized with the diagnosis of pneumonia and treated in Ankara between January 1, 2006 and December 30, 2019 were included in the study. The burden of disease according to the years was calculated as follows: after determining the number of patients with all-cause pneumonia, bacterial pneumonia and the empyema who were admitted to the pediatric infectious diseases service, we divided those numbers to admission numbers to all outpatient clinics in that year as the ratio in 100 000. The years 2006-2007 were accepted as pre-vaccine period, 2009-2010 as PCV7 period and 2012-2019 as PCV13 period. As 2008 and 2011 were the years when PCV7 and PCV13 vaccines implemented into the routine vaccination schedule, they were accepted as transition years and the patient data from these years were not used. All of the patients data were obtained from the patient files. There was a significant decrease in the disease burden of all-cause pneumonia in 0-18 years age and 0-24 months age group after PCV13 period compared to PCV7 period (p<0.001 and p<0.001). A statistically significant decrease was found in all-cause pneumonia among children older than 60 months after PCV13 period compared to PCV7 period and pre-vaccine period (p<0.05 and p<0.01, respectively). When pre-PCV13 (PCV7 and pre-vaccine periods together) and post-PCV13 periods were compared; in 0-18 years age, 0-24 months age and 24-60 months age groups, there was a significant decrease in the burden of disease due to all-cause pneumonia after PCV13 (p<0.001, p<0.001 and p<0.05) period. When the bacterial pneumonia disease burden in PCV13 period was evaluated, bacterial pneumonia disease burden in 0-18 years and 0-24 months age group was found to be significantly lower than in both pre-vaccine and PCV7 periods (p<0.001 and p<0.001). After PCV13 vaccine, the disease burden due to bacterial pneumonia was found to be significantly lower in 0-18 years age, 0-24 months age and older than 60 months age groups compared to pre-PCV13 period (p<0.001, p<0.001 and p<0.01). When PCV7 and PCV13 periods were compared in 0-18 years age group, a significant decrease was found in hospitalizations due to empyema after PCV13 (p<0.05). In conclusion, PCV7 and PCV13 led to a significant reduction in the incidence of all-cause pneumonia and bacterial pneumonia in children.


Assuntos
Empiema , Infecções Pneumocócicas , Pneumonia Bacteriana , Pneumonia Pneumocócica , Adolescente , Criança , Pré-Escolar , Empiema/epidemiologia , Empiema/prevenção & controle , Vacina Pneumocócica Conjugada Heptavalente , Humanos , Incidência , Lactente , Recém-Nascido , Infecções Pneumocócicas/epidemiologia , Vacinas Pneumocócicas , Pneumonia Pneumocócica/epidemiologia , Pneumonia Pneumocócica/prevenção & controle , Estudos Retrospectivos , Streptococcus pneumoniae
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