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A physician has to perform a benefit-risk assessment each time acyclovir is prescribed "off label" for children. A group of Polish infectious disease experts was created to develop evidence-based guidelines on the use of acyclovir in the treatment and prevention of varicella zoster and herpes simplex infections. In primary varicella zoster virus infections, oral acyclovir treatment is recommended in children over 12 years of age and should be considered in younger children who fall into one of the groups at risk of severe varicella. Intravenous acyclovir therapy in varicella is recommended in patients with immune deficiencies, newborns and in complicated cases. When there is a justified need for prevention of varicella, oral acyclovir prophylaxis may be considered if immunoglobulin cannot be administered, and if it is too late for vaccination. Oral acyclovir treatment of herpes zoster may be beneficial to otherwise healthy patients with a rash in places other than the trunk and in patients over 50 years of age. In immunocompetent patients with herpes simplex infections, indications for treatment with oral acyclovir include primary (genital herpes, skin herpes in children with atopic dermatitis, ocular herpes simplex, severe gingivostomatitis, paronychia and pharyngitis) and recurrent infections. Intravenous acyclovir should be administered for herpes infections in neonates, immunocompromised patients and patients who develop complications including neurological.
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Aciclovir/administração & dosagem , Herpes Simples/tratamento farmacológico , Herpes Simples/prevenção & controle , Herpes Zoster/tratamento farmacológico , Herpes Zoster/prevenção & controle , Herpesvirus Humano 3/efeitos dos fármacos , Simplexvirus/efeitos dos fármacos , Antivirais/administração & dosagem , Criança , Pré-Escolar , Consenso , Humanos , Hospedeiro Imunocomprometido/efeitos dos fármacos , Lactente , PolôniaRESUMO
This study analyzed data for 1098 children: 575 diagnosed with COVID-19 between January and June 2022 (early Omicron) and 523 hospitalized from July 2022 to April 2023 (late Omicron). New Omicron subvariants lead to similar recovery rates without deaths and acute respiratory distress syndrome in children as BA.1 and BA.2, however, they more often cause fever and croup. Children suffering from comorbidities, presenting with pulmonary lesions and older, may be prone to a more severe consequences of COVID-19 in terms of the currently dominating Omicron subvariants.
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BACKGROUND: Approximately 3.5 million children and adolescents worldwide are chronically infected with HCV. This study uses pharmacokinetic modeling to identify pediatric doses of elbasvir/grazoprevir (EBR/GZR) that achieve plasma concentrations similar to those seen in adults receiving the approved fixed-dose combination regimen of EBR/GZR. PATIENTS AND METHODS: We conducted a nonrandomized, single-arm, multicenter, open-label phase 2b trial in children and adolescents aged 3 to <18 years with chronic HCV genotype 1 or 4 infection (NCT03379506). Pharmacokinetic data were used to bridge efficacy and safety data from adults to children in a stepwise (oldest to youngest) manner. A total of 57 participants were enrolled: cohort 1 (aged 12 to <18 y), n=22; cohort 2 (aged 7 to <12 y), n=17; and cohort 3 (aged 3 to <7 y), n=18. RESULTS: Steady-state plasma exposures were achieved by week 4 for EBR and GZR in all cohorts and daily dosing achieved geometric mean steady-state area under the concentration-time curve at 0-24 hours that fell within comparability bounds established for adults. All participants achieved sustained virologic response 12 weeks after completing treatment (ie, undetectable HCV RNA 12 wk following completion of treatment). Headache (n=4), fatigue (n=4), and nausea (n=2) were the most common treatment-related adverse events (all mild or moderate); no participant discontinued because of an adverse event. CONCLUSIONS: Pediatric EBR/GZR pharmacokinetic models were successfully developed based on complex adult population pharmacokinetic models. At appropriate age-related doses, EBR/GZR is safe and effective in pediatric and adolescent participants with HCV infection.
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Antivirais , Hepatite C , Adulto , Adolescente , Humanos , Criança , Antivirais/efeitos adversos , Hepacivirus/genética , Quinoxalinas/efeitos adversos , Genótipo , Hepatite C/tratamento farmacológicoRESUMO
This study aimed to analyze the differences in severity and clinical characteristics of COVID-19 in infants hospitalized in Poland in 2021, when the dominance of variants of concern (VOCs) alpha and delta was reported, compared to 2020, when original (wild) SARS-CoV-2 was dominant (III-IV vs. I-II waves of the pandemic, respectively). In addition, the influence of the presence of comorbidities on the clinical course of COVID-19 in infants was studied. This multicenter study, based on the pediatric part of the national SARSTer database (SARSTer-PED), included 940 infants with COVID-19 diagnosed between March 1, 2020, and December 31, 2021, from 13 Polish inpatient centers. An electronic questionnaire, which addressed epidemiological and clinical data, was used. The number of hospitalized infants was significantly higher in 2021 than in 2020 (651 vs. 289, respectively). The analysis showed similar lengths of infant hospitalization in 2020 and 2021, but significantly more children were hospitalized for more than 7 days in 2020 (p < 0.009). In both analyzed periods, the most common route of infection for infants was household contact. There was an increase in the percentage of comorbidities, especially prematurity, in children hospitalized in 2021 compared to 2020. Among the clinical manifestations, fever was predominant among children hospitalized in 2021 and 2020. Cough, runny nose, and loss of appetite were significantly more frequently observed in 2021 (p < 0.0001). Severe and critical conditions were significantly more common among children with comorbidities. More infants were hospitalized during the period of VOCs dominance, especially the delta variant, compared to the period of wild strain dominance, even though indications for hospitalization did not include asymptomatic patients during that period. The course of COVID-19 was mostly mild, characterized mainly by fever and respiratory symptoms. Comorbidities, particularly from the cardiovascular system and prematurity, were associated with a more severe course of the disease in infants.
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BACKGROUND: This study aimed to analyze the differences in the epidemiologic and clinical characteristics of coronavirus disease 2019 (COVID-19) in children hospitalized in 2021, when the severe acute respiratory syndrome coronavirus 2 variants B.1.1.7 (alpha) and B.1.617.2 (delta) dominated, compared with 2020. METHODS: In this multicenter study based on the pediatric part of the national SARSTer register (SARSTer-PED), we included 2771 children (0-18 years) with COVID-19 diagnosed between March 1, 2020, and December 31, 2021, from 14 Polish inpatient centers. An electronic questionnaire, which addressed epidemiologic and clinical data, was used. RESULTS: Children hospitalized in 2021 were younger compared with those reported in 2020 (mean 4.1 vs. 6.8 years, P = 0 .01). Underlying comorbidities were reported in 22% of the patients. The clinical course was usually mild (70%). A significant difference in the clinical course assessment between 2020 and 2021 was found, with more asymptomatic patients in 2020 and more severely ill children in 2021. In total, 5% of patients were severely or critically ill, including <3% of the participants in 2020 and 7% in 2021. The calculated mortality rate was 0.1% in general and 0.2% in 2021. CONCLUSION: Infections with severe acute respiratory syndrome coronavirus 2 variants alpha and delta lead to a more severe course of COVID-19 with more pronounced clinical presentation and higher fatality rates than infection with an original strain. Most of the children requiring hospitalization due to COVID-19 do not have underlying comorbidities.
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COVID-19 , Criança , Humanos , COVID-19/epidemiologia , SARS-CoV-2 , Hospitalização , Progressão da DoençaRESUMO
BACKGROUND: Although COVID-19 is associated with a mild course in children, a certain proportion requires admission to hospital due to SARS-CoV-2 infection and coexisting diseases. The prospective multicenter study aimed to analyze clinical factors influencing the length of the hospital stay (LoHS) in children with COVID-19. METHODS: The study included 1283 children from 14 paediatric infectious diseases departments with diagnosed SARS-CoV-2 infection. Children were assessed in respective centres regarding indications for admission to hospital and clinical condition. History data, clinical findings, laboratory parameters, treatment, and outcome, were collected in the paediatric SARSTer register. The group of children with a hospital stays longer than seven days was compared to the remaining patients. Parameters with a statistically significant difference were included in further logistic regression analysis. RESULTS: One thousand one hundred and ten children were admitted to the hospital, 763 children were hospitalized >24 h and 173 children >7 days. 268 children had comorbidities. Two hundred and eleven children had an additional diagnosis with coinfections present in 135 children (11%). Factors increasing the risk of higher LoHS included pneumonia [odds ratio-OR 3.028; 95% confidence interval-CI (1.878-4.884)], gastrointestinal symptoms [OR = 1.556; 95%CI (1.049-2.322)], or rash [OR = 2.318; 95%CI (1.216-4.418)] in initial clinical findings. Comorbidities [OR = 2.433; 95%CI (1.662-3.563)], an additional diagnosis [OR = 2.594; 95%CI (1.679-4.007)] and the necessity of the empirical antibiotic treatment [OR = 2.834; 95%CI (2.834-6.713)] were further factors related to higher LoHS. CONCLUSIONS: The clinical course of COVID-19 was mild to moderate in most children. Factors increasing the risk of higher LoHS included pneumonia, gastrointestinal symptoms, comorbidities, an additional diagnosis, and the empirical antibiotic treatment.
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COVID-19 , Coinfecção , Criança , Coinfecção/epidemiologia , Hospitais , Humanos , Tempo de Internação , Polônia/epidemiologia , Estudos Prospectivos , SARS-CoV-2RESUMO
High influenza morbidity due to new antigenic strain AH1N1 was announced in Mexico in spring 2009. Influenza pandemic caused by the virus AH1N1/2009 spread around the world. Two pandemic waves were noted in most European countries: the first one was due to summer months migration, the second wave started in the beginning of common influenza season. We present features of both waves in children from the district of Lodz. We describe mild clinical course in 14 children who came from holiday in Spain with influenza and who were hospitalized and treated with osltamimivir due to unpredictable course of new influenza. We also present 22 influenza cases of the autumn pandemic wave, when children with severe complications of influenza and children from high risk groups were hospitalized and treated with antivirals. Experience that we have gained during 2009 influenza pandemic indicates that International Influenza Control System is very efficient, however more flexibility is required in application of treatment and prophylaxis procedures with new influenza strains. Applied methods of control should mostly depend on the virulence of pandemic strain.
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Surtos de Doenças/estatística & dados numéricos , Vírus da Influenza A Subtipo H1N1/isolamento & purificação , Influenza Humana/diagnóstico , Influenza Humana/epidemiologia , Admissão do Paciente/estatística & dados numéricos , Adolescente , Antivirais/uso terapêutico , Criança , Feminino , Férias e Feriados , Hospitalização , Humanos , Influenza Humana/tratamento farmacológico , Masculino , Polônia/epidemiologia , Fatores de Risco , Espanha , ViagemRESUMO
The meningococcal serogroup B (MenB) protein vaccine, 4CMenB, combined with MenA, MenC, MenW and MenY polysaccharide-protein conjugates for a pentavalent MenABCWY vaccine, can potentially protect against most causative agents of invasive meningococcal disease worldwide. Two phase 2b, randomized, multicenter studies were conducted (NCT02212457, NCT02946385) to assess the immunogenicity and safety of the MenABCWY vaccine as well as antibody persistence and response to a booster dose 2 years after the last vaccination, compared to 4CMenB vaccination. Participants (10 - 18 years), randomized (3:3:2:2:2:2), received the 4-component 4CMenB vaccine according to a 0-2 month (M) schedule or MenABCWY according to a 0-2, 0-6, 0-2-6, 0-1, or 0-11 M schedule. All participants received 5 injections (at M0, M1, M2, M6 and M12) with either the study vaccines or placebo/hepatitis A vaccine. Follow-on participants (4CMenB-0-2, MenABCWY-0-2, MenABCWY-0-6 and MenABCWY-0-2-6 groups) received one dose of either 4CMenB (4CMenB-0-2 group) or MenABCWY and newly enrolled, age-matched, meningococcal vaccine-naïve adolescents (randomized 1:1) received 2 doses (0-2 M) of either 4CMenB or MenABCWY. MenABCWY vaccination was immunogenic against MenB test strains. Non-inferiority for all 4 components of the 4CMenB vaccine could not be demonstrated for the 0-2 M schedule. Antibodies persisted up to 2 years post-MenABCWY vaccination and a booster dose induced an anamnestic response as higher titers were observed in follow-on participants compared to the first-dose response in vaccine-naïve participants. MenABCWY had a clinically-acceptable safety profile, not different from that of 4CMenB.
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Infecções Meningocócicas , Vacinas Meningocócicas , Neisseria meningitidis Sorogrupo B , Adolescente , Anticorpos Antibacterianos , Humanos , Imunogenicidade da Vacina , Infecções Meningocócicas/prevenção & controle , Vacinas Meningocócicas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
This prospective multicenter cohort study aimed to analyze the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in children. The study, based on the pediatric part of the Polish SARSTer register, included 1283 children (0 to 18 years) who were diagnosed with COVID-19 between 1 March 2020 and 31 December 2020. Household contact was reported in 56% of cases, more frequently in younger children. Fever was the most common symptom (46%). The youngest children (0-5 years) more frequently presented with fever, rhinitis and diarrhea. Teenagers more often complained of headache, sore throat, anosmia/ageusia and weakness. One fifth of patients were reported to be asymptomatic. Pneumonia was diagnosed in 12% of patients, more frequently in younger children. During the second wave patients were younger than during the first wave (median age 53 vs. 102 months, p < 0.0001) and required longer hospitalization (p < 0.0001). Significantly fewer asymptomatic patients were noted and pneumonia as well as gastrointestinal symptoms were more common. The epidemiological characteristics of pediatric patients and the clinical presentation of COVID-19 are age-related. Younger children were more frequently infected by close relatives, more often suffered from pneumonia and gastrointestinal symptoms and required hospitalization. Clinical courses differed significantly during the first two waves of the pandemic.
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BACKGROUND/AIMS: To establish if serum IL-18 concentration depends on presence of HCV-RNA in serum or in peripheral blood mononuclear cells. To relate serum levels of IL-18 to histological parameters of chronic hepatitis C. METHODOLOGY: IL-18 serum concentration was measured by ELISA in 92 patients with chronic hepatitis C (43 serum HCV-RNA positive and 49 serum HCV-RNA negative after treatment). In 13 patients from the latter group HCV-RNA persisted in peripheral blood mononuclear cells, while in 34 it was negative. Thirty-five healthy individuals were the control. RESULTS: IL-18 level was higher in 92 patients than in the control (77+/-31pg/mL us. 58+/-34pg/mL; p=0.002). Significant difference was found between the control and HCV-RNA positive (80+/-29pg/mL, p=0.002), HCV-RNA negative (75+/-32pg/mL, p=0.019), patients who eliminated HCV-RNA from serum and from PBMC (85+/-36pg/mL, p=0.002). IL-18 concentration was higher in serum HCV-RNA positive than in serum HCV-RNA negative patients (p=0.019) and it was related to histological inflammatory activity (p=0.008). CONCLUSIONS: Serum IL-18 concentration is related to presence of HCV-RNA in serum, in PBMC and liver inflammation. Increased level of this cytokine in patients with undetectable HCV-RNA may result from occluded persistence of the virus in the liver.
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Hepacivirus/genética , Interleucina-18/sangue , Leucócitos Mononucleares/química , RNA Viral/sangue , Adolescente , Adulto , Criança , Feminino , Humanos , Fígado/patologia , MasculinoRESUMO
BACKGROUND: Premature infants have lower short-term immune responses to vaccination than term infants, but patterns of antibody persistence in preterm infants over longer periods are not well established. This study assessed the persistence of antibody response to the 13-valent pneumococcal conjugate vaccine (PCV13) in formerly preterm versus term infants. METHODS: In total, 100 preterm and 100 term infants received PCV13 with routine vaccines at ages 2, 3, 4 and 12 months. Serotype-specific anticapsular immunoglobulin G (IgG)-binding antibodies and opsonophagocytic activity were determined 1 and 2 years after the last PCV13 dose. RESULTS: At 1 and 2 years after the last vaccination (toddler dose), IgG geometric mean concentrations (GMCs) for all serotypes had declined from levels measured 1 month after the toddler dose but remained above pretoddler dose levels. IgG GMCs were significantly lower in preterm than term subjects for a majority of serotypes at both follow-up time points. IgG GMCs increased in both groups for some serotypes from the 1-year to 2-year follow-up, whereas others declined. Opsonophagocytic activity results supported the IgG results. CONCLUSIONS: The routine (3 + 1) vaccination schedule is likely to offer long-term protection against invasive pneumococcal disease in preterm infants and should be initiated regardless of gestational age or weight at birth, without delay of the toddler dose.
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Anticorpos Antibacterianos/sangue , Imunoglobulina G/sangue , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/imunologia , Streptococcus pneumoniae/imunologia , Feminino , Seguimentos , Humanos , Esquemas de Imunização , Lactente , Recém-Nascido Prematuro , Masculino , Infecções Pneumocócicas/imunologia , Vacinas Pneumocócicas/administração & dosagem , VacinaçãoRESUMO
OBJECTIVE: Prophylactic antipyretic use during pediatric vaccination is common. This study assessed whether paracetamol or ibuprofen prophylaxis interfere with immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13) given concomitantly with the combined DTaP/HBV/IPV/Hib vaccine. METHODS: Subjects received prophylactic paracetamol or ibuprofen at 0, 6-8, and 12-16 h after vaccination, or 6-8 and 12-16 h after vaccination at 2, 3, 4, and 12months of age. At 5 and 13months, immune responses were evaluated versus responses in controls who received no prophylaxis. RESULTS: After the infant series, paracetamol recipients had lower levels of circulating serotype-specific pneumococcal anticapsular immunoglobulin G than controls, reaching significance (P<0.0125) for 5 serotypes (serotypes 3, 4, 5, 6B, and 23F) when paracetamol was started at vaccination. Opsonophagocytic activity assay (OPA) results were similar between groups. Ibuprofen did not affect pneumococcal responses, but significantly (P<0.0125) reduced antibody responses to pertussis filamentous hemagglutinin and tetanus antigens after the infant series when started at vaccination. No differences were observed for any group after the toddler dose. CONCLUSIONS: Prophylactic antipyretics affect immune responses to vaccines; these effects vary depending on the vaccine, antipyretic agent, and time of administration. In infants, paracetamol may interfere with immune responses to pneumococcal antigens, and ibuprofen may reduce responses to pertussis and tetanus antigens. The use of antipyretics for fever prophylaxis during infant vaccination merits careful consideration. ClinicalTrials.gov identifier: NCT01392378https://clinicaltrials.gov/ct2/show/NCT01392378?term=NCT01392378&rank=1.
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Acetaminofen/administração & dosagem , Antipiréticos/administração & dosagem , Quimioprevenção/métodos , Febre/prevenção & controle , Ibuprofeno/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/imunologia , Anticorpos Antibacterianos/sangue , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Interações Medicamentosas , Feminino , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas contra Hepatite B/efeitos adversos , Humanos , Lactente , Masculino , Proteínas Opsonizantes/sangue , Fagocitose , Vacinas Pneumocócicas/administração & dosagem , Vacina Antipólio de Vírus Inativado/efeitos adversos , Vacinas Combinadas/efeitos adversosRESUMO
THE AIM: To estimate the incidence of MRSA strains in hospitalized children, the analysis of antibiotic treatment necessity and its effectiveness. RESULTS: In 54 cases biological material obtained from hospitalized children revealed the culture of S. aureus, 22% of them were MRSA strains. Micro-organisms were cultured from throat swabs, faeces, purulent skin lesions, blood, cerebrospinal fluid. Antibiotic treatment was applied in 3 cases. Vancomycin (Edicin) was used as the first-choice option. Symptoms of drug intolerance was observed in all three cases after the first or the second dose, must have been immediately withdrawn. CONCLUSIONS: MRSA strains are common in children population, they are not only nosocomial strains. Infections caused by S. aureus MRSA may result in life-threatening diseases. The generic formula of Vancomycin, that is used in Poland may cause serious side effects, which restricts narrow range of therapeutic options to eradicate MRSA strains.
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Resistência a Meticilina , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/microbiologia , Staphylococcus aureus/classificação , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Criança , Humanos , Polônia , Especificidade da Espécie , Infecções Estafilocócicas/diagnóstico , Resultado do Tratamento , Vancomicina/administração & dosagem , Vancomicina/efeitos adversosRESUMO
THE AIM: To follow persistence of HCV-RNA in PBMC in patients with chronic hepatitis C (CHC). To estimate the influence of this phenomenon on the cellular immune response of peripheral blood lymphocytes. MATERIAL AND METHODS: 8 HCV-RNA in PBMC positive children, with undetectable serum HCV-RNA after antiviral treatment, have been examined every 2-3 years. The amount of IFN-gamma, IL-12 and IL-18 secreted by PBMC obtained from the children after stimulation with phytohemagglutinin (PHA) was measured. RESULTS: Spontaneous elimination of HCV-RNA from PBMC in 2 to 6 years after treatment was found in all children. In two children HCV-RNA detectable both in serum and in PBMC, without recurrence of hepatitis, was found in single examination. PBMC containing HCV-RNA secreted more IFN-gamma than PBMC lacking it (1221 +/- 458 pg/ml vs. 651 +/- 147 pg/ml; p=0.009, similar correlation was revealed with the regard of IL-12: 21.8 +/- 12.3 pg/ml vs. 5,6 +/- 3,3 pg/ml respectively; p=0.009. Production and release of IL-18 were not correlated with HCV-RNA persistence (p=0.12). CONCLUSION: Patients with CHC and persistence of HCV-RNA in PBMC require longitudinal follow-up in the respect of possible reseroconversion. PBMC containing HCV-RNA reveal enhanced cellular immune response, which most probably effects in spontaneous elimination of the virus.
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Hepacivirus/imunologia , Hepacivirus/isolamento & purificação , Antígenos da Hepatite C/isolamento & purificação , Hepatite C Crônica/imunologia , Hepatite C Crônica/virologia , Leucócitos Mononucleares/virologia , RNA Viral/sangue , Adolescente , Antivirais/uso terapêutico , Criança , Esquema de Medicação , Quimioterapia Combinada , Feminino , Antígenos da Hepatite C/efeitos dos fármacos , Antígenos da Hepatite C/imunologia , Hepatite C Crônica/tratamento farmacológico , Humanos , Leucócitos Mononucleares/efeitos dos fármacos , Masculino , RNA Viral/efeitos dos fármacos , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Resultado do Tratamento , Carga ViralRESUMO
INTRODUCTION: Rotavirus (RV) infection is the most common cause of gastroenteritis in children. This paper identifies the most common genotypes of rotaviruses isolated from children hospitalized with gastroenteritis and attempts to determine any relationship between infection with a certain rotavirus genotype. MATERIAL AND METHODS: The investigated group consisted of 68 consecutive children with rotavirus gastroenteritis (confirmed by an agglutination test). Rotavirus genotype was determined in stool samples obtained from each child. RESULTS: The P[9]VP4 genotype was observed in 41/61 positive samples (over 67.2%) that were permanently associated with the G3 VP7 genotype. Moreover, G3 was determined as the most commonly isolated G type (77.94%). As well as the P[9]G3 type, G3 was also found in the P[4] type (5 cases). Twenty-six out of 61 (42.6%) children in whom rotavirus genotype was determined were co-infected with pathogenic bacteria. No statistical correlation was observed between rotavirus P[9]G3 gastroenteritis and digestive tract co-infection with pathogenic bacteria (p > 0.05). Elevated ALT activity was found in 34/59 (57.6%) cases of rotavirus gastroenteritis. Elevated ALT serum level was found to correlate with P[9]G3 rotavirus genotype but concomitant infections did not. CONCLUSIONS: The most common genotype of rotaviruses observed in our group of children, P[9]G3, has rarely been described. Co-infection of the digestive tract with pathogenic bacteria and elevated serum ALT concentrations were found to be the most frequent phenomena. A correlation between P[9]G3 rotavirus genotype and elevated serum ALT level was found, but no significant relationship was identified between concomitant infections and P[9]G3 genotype.
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BACKGROUND: Polysorbate 80 (P80), a nonionic detergent used to solubilize proteins, is used in both oral and injectable medications including vaccines. Development studies with 13-valent pneumococcal conjugate vaccine (PCV13) showed that adding P80 resulted in a more robust manufacturing process. Before adding P80 to the formulation of PCV13, we investigated the immunogenicity and safety of PCV13 with and without P80. METHODS: Phase 3, parallel-group, randomized, active-controlled, double-blind multicenter trial was conducted at 15 sites in Poland. Healthy infants were randomized (1:1) to receive PCV13+P80 or PCV13 without P80 given at ages 2, 3, 4 and 12 months concomitantly with DTaP-IPV-Hib at 2, 3 and 4 months; hepatitis B at 2 months and measles, mumps, and rubella at 12 months. Serotype-specific antipneumococcal immune responses were evaluated using antipolysaccharide capsular immunoglobulin (Ig)G responses and opsonophagocytic activity (OPA) assay. Safety data were also collected. RESULTS: The 2 treatment groups were demographically similar. Following the infant immunization series, anticapsular IgG antibody geometric mean concentrations and OPA geometric mean titers for each serotype were within 2-fold between the 2 groups. Formal noninferiority criteria for comparison of proportion of responders (subjects with IgG titers ≥0.35 µg/mL) were met for 11 of the 13 serotypes. Overall population responses were highly similar. Anticapsular IgG responses were also within 2-fold following the toddler dose. Safety profiles were similar between the 2 groups. CONCLUSIONS: Addition of P80 to PCV13 did not adversely affect PCV13 immunogenicity or safety when compared with vaccine formulated without P80.
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Excipientes/administração & dosagem , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/imunologia , Polissorbatos/administração & dosagem , Tensoativos/administração & dosagem , Anticorpos Antibacterianos/sangue , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Voluntários Saudáveis , Humanos , Imunoglobulina G/sangue , Lactente , Masculino , Proteínas Opsonizantes/sangue , Fagocitose , Vacinas Pneumocócicas/administração & dosagem , PolôniaRESUMO
OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants. METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine). RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 µg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups. CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.
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Anticorpos Antibacterianos/sangue , Imunoglobulina G/sangue , Doenças do Prematuro/imunologia , Doenças do Prematuro/prevenção & controle , Vacinas Pneumocócicas/administração & dosagem , Vacinas Pneumocócicas/imunologia , Streptococcus pneumoniae/imunologia , Formação de Anticorpos/imunologia , Especificidade de Anticorpos/imunologia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Injeções Intramusculares , Masculino , Vacinas Pneumocócicas/efeitos adversos , Polônia , EspanhaRESUMO
One and 6 months after vaccination with hepatitis A virus vaccine (HAVRIX 720 Junior), immunologic responses (anti-hepatitis A virus >/=20 mIU/ml) in children with chronic hepatitis C infection seroprotection were 92% (23/25) and 75% (9/12) in children with chronic hepatitis B infection 87% (21/24) and 88% (15/17) and in healthy children 91% (20/22) at both times. A booster dose induced seroprotection in all children.
Assuntos
Anticorpos Anti-Hepatite A/imunologia , Vacinas contra Hepatite A/imunologia , Hepatite A/imunologia , Cirrose Hepática/imunologia , Adolescente , Estudos de Casos e Controles , Criança , Pré-Escolar , Doença Crônica , Estudos de Coortes , Feminino , Hepatite A/complicações , Hepatite A/prevenção & controle , Vacinas contra Hepatite A/administração & dosagem , Anticorpos Anti-Hepatite B/imunologia , Hepatite B Crônica/imunologia , Hepatite B Crônica/prevenção & controle , Anticorpos Anti-Hepatite C/imunologia , Hepatite C Crônica/imunologia , Hepatite C Crônica/prevenção & controle , Humanos , Cirrose Hepática/complicações , Masculino , Prognóstico , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Medição de Risco , Sensibilidade e Especificidade , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/imunologiaRESUMO
HGV was discovered in 1995. It belongs to Flaviviruses and it is found worldwide. At first it was though to cause chronic hepatitis, in fact its pathogenicity is up till now unclear. The aim of this work was to estimate the prevalence of anti-HGV antibodies among children suffering from chronic hepatitis B (CHB), chronic hepatitis C (CHC) and chronic hepatitis B + C (CHB + C) and to compare it with the prevalence in healthy children in the district of Lodz, Poland, and to assess the influence of HGV infection on biochemical and histological parameters of chronic liver disease. PATIENTS AND METHODS. 153 children with chronic hepatitis B and C and 22 healthy children have been investigated. The presence of anti-HGV was assessed by ELISA. In children with chronic hepatitis prior the entrance to the study HCV-RNA, HBsAg, HBeAg, and if HBeAg-negative also HBV-DNA were assessed. Thick needle percutaneous liver biopsy was performed in each case. RESULTS. Of 153 children with chronic hepatitis, 17 (11%) were anti-HGV positive. Anti-HGV positivity was found in 3 (3%) of 94 children with CHB, 12 (25%) of 48 children with CHC, and 2 (18%) of 11 children with CHB + C. Anti-HGV were not found in any of 22 healthy children. Previous HGV infection was associated with CHC (p = 0.0001), history of hospitalization (p = 0.002) or blood transfusion (p = 0.0006) as compared with children with CHB. Serum albumin or gamma globulin concentration as well as ALT level or degree of inflammation and fibrosis in liver biopsy specimen were not correlated with previous HGV infection.
Assuntos
Infecções por Flaviviridae/epidemiologia , Vírus GB C/isolamento & purificação , Hepatite B Crônica/complicações , Hepatite C Crônica/complicações , Hepatite Viral Humana/epidemiologia , Adolescente , Biópsia , Criança , Pré-Escolar , Ensaio de Imunoadsorção Enzimática , Feminino , Infecções por Flaviviridae/diagnóstico , Infecções por Flaviviridae/virologia , Vírus GB C/imunologia , Anticorpos Anti-Hepatite/sangue , Hepatite Viral Humana/diagnóstico , Hepatite Viral Humana/virologia , Humanos , Hepatopatias/imunologia , Hepatopatias/virologia , Masculino , Polônia/epidemiologia , Prevalência , Estudos Soroepidemiológicos , Reação TransfusionalRESUMO
Programmes of vaccination against hepatitis B were introduced in Poland for the first time in 1989. The paper presents the influence of these programmes on the decrease of hepatitis B incidence in the last twelve years. We have described the methods of estimating the efficacy of hepatitis B vaccination and presented the causes of weak anti-HBV response depending on the vaccine that was used and the features of the population that was vaccinated. Special vaccination schemes were established to achieve optimal response in chronically ill or immunosuppressed patients. We have cited the latest opinions concerning booster doses in healthy people and in patients at high risk of HBV infection.