RESUMO
The impact of bacterial conjugate vaccines on acute otitis media (AOM) is affected by several factors including population characteristics, bacterial etiology and vaccine conjugation method, carrier, and coverage. This study estimated the baseline etiology, distribution, and antibiotic susceptibility of bacterial serotypes that causes AOM in children aged <5 years in a public setting in Santiago, Chile.Children aged ≥3 months and <5 years referred to the physician for treatment of AOM episodes (with an onset of symptoms <72âh) were enrolled between September 2009 and September 2010. Middle ear fluid (MEF) was collected by tympanocentesis or by otorrhea for identification and serotyping of bacteria. Antibacterial susceptibility was tested using E-test (etrack: 112671).Of 160 children (mean age 27.10â±â15.83 months) with AOM episodes, 164 MEF samples (1 episode each from 156 children; 2 episodes each from 4 children) were collected. Nearly 30% of AOM episodes occurred in children aged 12 to 23 months. Streptococcus pneumoniae (41.7% [58/139]) and Haemophilus influenzae (40.3% [56/139]) were predominant among the cultures that showed bacterial growth (85% [139/164]). All Streptococcus pneumoniae positive episodes were serotyped, 19F (21%) and 14 (17%) were the predominant serotypes; all Haemophilus influenzae strains were nontypeable. Streptococcus pneumoniae were resistant to penicillin (5%) and erythromycin (33%); Haemophilus influenzae were resistant to ampicillin (14%) and cefuroxime and cefotaxime (2% each).AOM in Chilean children is predominantly caused by Streptococcus pneumoniae and nontypeable Haemophilus influenzae. Use of a broad spectrum vaccine against these pathogens might aid the reduction of AOM in Chile.
Assuntos
Farmacorresistência Bacteriana , Haemophilus influenzae/classificação , Otite Média/microbiologia , Streptococcus pneumoniae/classificação , Pré-Escolar , Chile/epidemiologia , Feminino , Infecções por Haemophilus/epidemiologia , Humanos , Lactente , Masculino , Otite Média/epidemiologia , Infecções Pneumocócicas/epidemiologia , Estudos Prospectivos , Estações do Ano , SorotipagemRESUMO
BACKGROUND: Rotavirus diarrhea is one of the most important vaccine-preventable causes of severe diarrhea in children worldwide. There are two live-attenuated virus vaccines licensed, Rotarix (RV1) a monovalent vaccine by GlaxoSmithKline and a pentavalent vaccine, RotaTeq(RV5), by Merck & Co., with similar results. This study aim was to evaluate the cost-effectiveness of the utilization of RV1 compared with RV5 in Argentina. METHODS: A deterministic Markov model based on the lifetime follow up of a static cohort was used. Quality Adjusted Life Years (QALYs) as a measure of results, the perspective of the health care system and a 5% discount rate for health benefits and costs has been used. A review of the literature to obtain epidemiologic and resources utilization of rotavirus diarrhea was performed. The sources used to estimate epidemiologic parameters were the National Health Surveillance System, the national mortality statistics and national database of hospital discharges records. Costs were obtained from different health subsectors and are expressed in local currency. RESULTS: Both vaccination alternatives were less costly and more effective than the strategy without vaccination (total costs $ 69,700,645 and 2575 total QALYs lost). When comparing RV1 vs. RV5, RV1 was less expensive ($ 60,174,508 vs. $ 67,545,991 total costs) and more effective (1105 vs. 1213 total QALYs lost) than RV5, RV1 being therefore a dominating strategy. Probabilistic sensitivity analysis showed results to be robust with a 100% probability of being cost-effective at a WTP threshold of 1 GDP per capita when comparing the RV1 vs. no vaccination. CONCLUSION: Both RV1 and RV5 schedules dominate the no vaccination strategy and RV5 was dominated by RV1. This information is a valuable input regarding the incorporation of this kind of vaccines into the national vaccination programs.
Assuntos
Programas de Imunização/economia , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/economia , Argentina/epidemiologia , Pré-Escolar , Análise Custo-Benefício , Diarreia/epidemiologia , Diarreia/virologia , Humanos , Lactente , Cadeias de Markov , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Rotavirus , Infecções por Rotavirus/epidemiologia , Vacinas contra Rotavirus/uso terapêutico , Vacinação/economia , Vacinas Atenuadas/economia , Vacinas Atenuadas/uso terapêuticoRESUMO
Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.
Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Seringas , Adolescente , Anticorpos/análise , Antígenos/análise , Criança , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Feminino , Humanos , Imunização Secundária , Masculino , Método Simples-Cego , Resultado do Tratamento , VacinaçãoRESUMO
BACKGROUND: In Chile, significant reductions in cervical cancer incidence and mortality have been observed due to implementation of a well-organized screening program. However, it has been suggested that the inclusion of human papillomavirus (HPV) vaccination for young adolescent women may be the best prospect to further reduce the burden of cervical cancer. This cost-effectiveness study comparing two available HPV vaccines in Chile was performed to support decision making on the implementation of universal HPV vaccination. METHODS: The present analysis used an existing static Markov model to assess the effect of screening and vaccination. This analysis includes the epidemiology of low-risk HPV types allowing for the comparison between the two vaccines (HPV-16/18 AS04-adjuvanted vaccine and the HPV-6/11/16/18 vaccine), latest cross-protection data on HPV vaccines, treatment costs for cervical cancer, vaccine costs and 6% discounting per the health economic guideline for Chile. RESULTS: Projected incremental cost-utility ratio (ICUR) and incremental cost-effectiveness ratio (ICERs) for the HPV-16/18 AS04-adjuvanted vaccine was 116 United States (US) dollars per quality-adjusted life years (QALY) gained or 147 US dollars per life-years (LY) saved, while the projected ICUR/ICER for the HPV-6/11/16/18 vaccine was 541 US dollars per QALY gained or 726 US dollars per LY saved. Introduction of any HPV vaccine to the present cervical cancer prevention program of Chile is estimated to be highly cost-effective (below 1X gross domestic product [GDP] per capita, 14278 US dollars). In Chile, the addition of HPV-16/18 AS04-adjuvanted vaccine to the existing screening program dominated the addition of HPV-6/11/16/18 vaccine. In the probabilistic sensitivity analysis results show that the HPV-16/18 AS04-adjuvanted vaccine is expected to be dominant and cost-saving in 69.3% and 77.6% of the replicates respectively. CONCLUSIONS: The findings indicate that the addition of any HPV vaccine to the current cervical screening program of Chile will be advantageous. However, this cost-effectiveness model shows that the HPV-16/18 AS04-adjuvanted vaccine dominated the HPV-6/11/16/18 vaccine. Beyond the context of Chile, the data from this modelling exercise may support healthcare policy and decision-making pertaining to introduction of HPV vaccination in similar resource settings in the region.
Assuntos
Alphapapillomavirus/imunologia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Infecções por Papillomavirus/economia , Vacinas contra Papillomavirus/economia , Neoplasias do Colo do Útero/economia , Vacinação/economia , Adjuvantes Imunológicos/economia , Criança , Chile , Custos e Análise de Custo , Proteção Cruzada , Feminino , Papillomavirus Humano 11/imunologia , Papillomavirus Humano 16/imunologia , Papillomavirus Humano 18/imunologia , Papillomavirus Humano 6/imunologia , Humanos , Cadeias de Markov , Modelos Teóricos , Infecções por Papillomavirus/prevenção & controle , Infecções por Papillomavirus/virologia , Anos de Vida Ajustados por Qualidade de Vida , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/virologiaRESUMO
BACKGROUND: The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. METHODS AND FINDINGS: This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases. CONCLUSIONS: Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice. TRIAL REGISTRATION: www.ClinicalTrials.gov NCT00466947.
Assuntos
Proteínas de Bactérias/imunologia , Proteínas de Transporte/imunologia , Haemophilus influenzae/imunologia , Imunoglobulina D/imunologia , Lipoproteínas/imunologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/imunologia , Streptococcus pneumoniae/imunologia , Vacinação , Vacinas Conjugadas/imunologia , Anticorpos Antibacterianos/sangue , Pré-Escolar , Método Duplo-Cego , Infecções por Haemophilus/microbiologia , Humanos , Imunização Secundária , Lactente , Análise de Intenção de Tratamento , América Latina , Otite Média/imunologia , Otite Média/microbiologia , Otite Média/prevenção & controle , Infecções Pneumocócicas/imunologia , Infecções Pneumocócicas/microbiologia , Resultado do TratamentoRESUMO
INTRODUCTION: Acute gastroenteritis is a common disease in children. Rotavirus is the major etiologic agent. OBJECTIVES: To describe the epidemiological and clinical characteristics of acute gastroenteritis according to their etiology (rotavirus or other) in children younger than 5 years old in a private institution in the City of Buenos Aires. SECONDARY OBJECTIVE: to analyze related costs. MATERIAL AND METHODS: Cross sectional, descriptive, observational study conducted during one year in children younger than 5 years old with gastroenteritis. The presence of rotavirus was diagnosed with the VIKIA® Rota-Adeno test. Demographic, clinical and immunization data were collected. A univariate data analysis was performed. RESULTS: A total of 275 patients were included; 18.5% of them were R+. Rotavirus was more common in children younger than 2 years old and in the period between March and June. The cases of rotavirus gastroenteritis were more severe, required more hospitalizations (OR 2.07; 95% CI 1.17-7.13), and resulted in higher costs. In the sample studied, the immunization outcome measure reduced the risk of rotavirus infection. CONCLUSIONS: Acute gastroenteritis caused by rotavirus were different from other etiologies in that they had a seasonal peak and in relation to the median age of patients, the severity of the condition, the association with hospitalization and the increase in costs.
Assuntos
Gastroenterite/diagnóstico , Gastroenterite/epidemiologia , Infecções por Rotavirus , Doença Aguda , Argentina , Pré-Escolar , Estudos Transversais , Gastroenterite/virologia , Hospitalização , Hospitais Privados , Humanos , Lactente , Saúde da População UrbanaRESUMO
Introducción. La gastroenteritis aguda es una enfermedad frecuente en pediatría. Rotavirus es el principal agente etiológico. Objetivos. Describir las características epidemiológicas y clínicas de las gastroenteritis agudas según su etiología por rotavirus u otra en niños menores de 5 años en una institución privada de Buenos Aires. Objetivo secundario: evaluar los costos. Material y métodos. Estudio transversal, descriptivo, observacional, de un año de duración, en niños menores de 5 años con gastroenteritis. El rotavirus fue diagnosticado mediante la prueba VIKIA« Rota-Adeno. Se recolectaron datos demográficos, clínicos y de vacunación. Se realizó el análisis univariado de los datos. Resultados. Se incluyeron 275 pacientes; 18,5% fueron R+. Rotavirus fue más frecuente en los menores de 2 años y entre marzo y junio. Las gastroenteritis por rotavirus fueron más graves, requirieron más internaciones (OR 2,07; IC 95% 1,17 a 7,13) y provocaron más costos. En la muestra estudiada la variable vacunación redujo el riesgo de infección por rotavirus. Conclusiones. Las gastroenteritis agudas por rotavirus se diferenciaron de otras etiologías por tener un pico estacional, y por la mediana de edad, la gravedad, la asociación con internación y el aumento de los costos.(AU)
Introduction. Acute gastroenteritis is a common disease in children. Rotavirus is the major etiologic agent. Objectives. To describe the epidemiological and clinical characteristics of acute gastroenteritis according to their etiology (rotavirus or other) in children younger than 5 years old in a private institution in the City of Buenos Aires. Secondary objective: to analyze related costs. Material and Methods. Cross sectional, descriptive, observational study conducted during one year in children younger than 5 years old with gastroenteritis. The presence of rotavirus was diagnosed with the VIKIA« Rota-Adeno test. Demographic, clinical and immunization data were collected. A univariate data analysis was performed. Results. A total of 275 patients were included; 18.5% of them were R+. Rotavirus was more common in children younger than 2 years old and in the period between March and June. The cases of rotavirus gastroenteritis were more severe, required more hospitalizations (OR 2.07; 95% CI 1.17-7.13), and resulted in higher costs. In the sample studied, the immunization outcome measure reduced the risk of rotavirus infection. Conclusions. Acute gastroenteritis caused by rotavirus were different from other etiologies in that they had a seasonal peak and in relation to the median age of patients, the severity of the condition, the association with hospitalization and the increase in costs.(AU)
Assuntos
Pré-Escolar , Humanos , Lactente , Gastroenterite/diagnóstico , Gastroenterite/epidemiologia , Infecções por Rotavirus , Doença Aguda , Argentina , Estudos Transversais , Gastroenterite/virologia , Hospitalização , Hospitais Privados , Saúde da População UrbanaRESUMO
Introducción. La gastroenteritis aguda es una enfermedad frecuente en pediatría. Rotavirus es el principal agente etiológico. Objetivos. Describir las características epidemiológicas y clínicas de las gastroenteritis agudas según su etiología por rotavirus u otra en niños menores de 5 años en una institución privada de Buenos Aires. Objetivo secundario: evaluar los costos. Material y métodos. Estudio transversal, descriptivo, observacional, de un año de duración, en niños menores de 5 años con gastroenteritis. El rotavirus fue diagnosticado mediante la prueba VIKIA® Rota-Adeno. Se recolectaron datos demográficos, clínicos y de vacunación. Se realizó el análisis univariado de los datos. Resultados. Se incluyeron 275 pacientes; 18,5% fueron R+. Rotavirus fue más frecuente en los menores de 2 años y entre marzo y junio. Las gastroenteritis por rotavirus fueron más graves, requirieron más internaciones (OR 2,07; IC 95% 1,17 a 7,13) y provocaron más costos. En la muestra estudiada la variable vacunación redujo el riesgo de infección por rotavirus. Conclusiones. Las gastroenteritis agudas por rotavirus se diferenciaron de otras etiologías por tener un pico estacional, y por la mediana de edad, la gravedad, la asociación con internación y el aumento de los costos.
Introduction. Acute gastroenteritis is a common disease in children. Rotavirus is the major etiologic agent. Objectives. To describe the epidemiological and clinical characteristics of acute gastroenteritis according to their etiology (rotavirus or other) in children younger than 5 years old in a private institution in the City of Buenos Aires. Secondary objective: to analyze related costs. Material and Methods. Cross sectional, descriptive, observational study conducted during one year in children younger than 5 years old with gastroenteritis. The presence of rotavirus was diagnosed with the VIKIA® Rota-Adeno test. Demographic, clinical and immunization data were collected. A univariate data analysis was performed. Results. A total of 275 patients were included; 18.5% of them were R+. Rotavirus was more common in children younger than 2 years old and in the period between March and June. The cases of rotavirus gastroenteritis were more severe, required more hospitalizations (OR 2.07; 95% CI 1.17-7.13), and resulted in higher costs. In the sample studied, the immunization outcome measure reduced the risk of rotavirus infection. Conclusions. Acute gastroenteritis caused by rotavirus were different from other etiologies in that they had a seasonal peak and in relation to the median age of patients, the severity of the condition, the association with hospitalization and the increase in costs.
Assuntos
Pré-Escolar , Humanos , Lactente , Gastroenterite/diagnóstico , Gastroenterite/epidemiologia , Infecções por Rotavirus , Doença Aguda , Argentina , Estudos Transversais , Gastroenterite/virologia , Hospitalização , Hospitais Privados , Saúde da População UrbanaRESUMO
INTRODUCTION: Acute gastroenteritis is a common disease in children. Rotavirus is the major etiologic agent. OBJECTIVES: To describe the epidemiological and clinical characteristics of acute gastroenteritis according to their etiology (rotavirus or other) in children younger than 5 years old in a private institution in the City of Buenos Aires. SECONDARY OBJECTIVE: to analyze related costs. MATERIAL AND METHODS: Cross sectional, descriptive, observational study conducted during one year in children younger than 5 years old with gastroenteritis. The presence of rotavirus was diagnosed with the VIKIA« Rota-Adeno test. Demographic, clinical and immunization data were collected. A univariate data analysis was performed. RESULTS: A total of 275 patients were included; 18.5
of them were R+. Rotavirus was more common in children younger than 2 years old and in the period between March and June. The cases of rotavirus gastroenteritis were more severe, required more hospitalizations (OR 2.07; 95
CI 1.17-7.13), and resulted in higher costs. In the sample studied, the immunization outcome measure reduced the risk of rotavirus infection. CONCLUSIONS: Acute gastroenteritis caused by rotavirus were different from other etiologies in that they had a seasonal peak and in relation to the median age of patients, the severity of the condition, the association with hospitalization and the increase in costs.
Assuntos
Gastroenterite/diagnóstico , Gastroenterite/epidemiologia , Infecções por Rotavirus , Doença Aguda , Argentina , Pré-Escolar , Estudos Transversais , Gastroenterite/virologia , Hospitalização , Hospitais Privados , Humanos , Lactente , Saúde da População UrbanaRESUMO
The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix™) were assessed in 240 healthy Chilean children randomized to receive 3 doses of PHiD-CV (PHiD-CV group) or hepatitis A vaccine (HAV control group) at 2-4-6 months of age. All were offered 1 HAV dose at 12 months (outside study). The PHiD-CV group received a second HAV dose at 18-21 months and PHiD-CV booster at 20-23 months. The HAV control group received 2 PHiD-CV catch-up doses at 18-21 and 20-23 months. Adverse events were recorded and pneumococcal antibody responses and opsonophagocytic activity (OPA) were measured. Both PHiD-CV vaccination schedules were well tolerated and immunogenic against the pneumococcal vaccine serotypes and protein D. The reactogenicity of PHiD-CV primary, booster and catch-up doses was in line with previous PHiD-CV studies, although generally higher than with HAV. For each vaccine serotype, the percentage of subjects with antibody concentrations ≥0.2 µg/ml (GSK's 22F-inhibition ELISA) was at least 93.2% following 3 PHiD-CV primary doses and at least 97.4% post-booster; percentages with OPA titers ≥8 were at least 91.7% post-booster. After 2-dose catch-up, at least 94.3% of children had antibody concentrations ≥0.2 µg/ml against each serotype except 6B (84.3%); at least 95.2% had OPA titers ≥8 except against serotypes 1, 5 and 6B. In conclusion, the safety profiles of 2 PHiD-CV vaccination schedules (3-dose primary plus booster and 2-dose catch-up) were in line with previous studies and PHiD-CV was immunogenic for all 10 vaccine serotypes and protein D.
Assuntos
Infecções por Haemophilus/epidemiologia , Infecções por Haemophilus/prevenção & controle , Infecções Pneumocócicas/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/imunologia , Anticorpos Antibacterianos/sangue , Pré-Escolar , Chile/epidemiologia , Feminino , Humanos , Imunização Secundária/métodos , Lactente , Masculino , Vacinas Pneumocócicas/administração & dosagem , Vacinação/métodosRESUMO
OBJECTIVE: To determine the prevalence rates of the different HPV types in cervical cancer lesions in Chile to facilitate the development of prophylactic human papillomavirus (HPV) vaccines effective for that country. METHOD: Biopsy samples of 312 cervical cancer lesions were assessed for HPV type by reverse-line blotting assay. RESULTS: HPV DNA was found in 94.2% of the lesions, 67.2% harboring 1 viral type and the remainder harboring more than 1 type. HPV-16 was the most frequent type in single infections (50.5%), followed by HPV-18 (7.8%), HPV-31 (2.4%), and HPV-45 (2.0%). HPV-16 was also present in 98.7% of dual and multiple infections, its most frequent association being with HPV-18. CONCLUSIONS: HPV types 16, 18, 31, and 45, alone or combined with other types, were observed in the biopsy samples of up to 80.5% of cervical cancer lesions.
Assuntos
Adenocarcinoma/virologia , Carcinoma de Células Escamosas/virologia , Papillomavirus Humano 16/isolamento & purificação , Papillomavirus Humano 18/isolamento & purificação , Infecções por Papillomavirus/virologia , Neoplasias do Colo do Útero/virologia , Adenocarcinoma/epidemiologia , Adulto , Carcinoma de Células Escamosas/epidemiologia , Chile/epidemiologia , DNA Viral/análise , Feminino , Genótipo , Papillomavirus Humano 16/genética , Papillomavirus Humano 18/genética , Humanos , Pessoa de Meia-Idade , Infecções por Papillomavirus/epidemiologia , Prevalência , Neoplasias do Colo do Útero/epidemiologia , Adulto JovemRESUMO
A randomised trial was conducted in 285 adults not immune to hepatitis B (HB) to compare the safety and immunogenicity of a commercial aluminium-adjuvanted HB vaccine with and without an additional new adjuvant (AgB/RC-210-04 or AgB study groups, respectively). The additional adjuvant RC-529 is a fully synthetic monosaccharide mimetic of monophosphoryl lipid A. Subjects in the AgB/RC-210-04 (n=136) and AgB (n=149) groups were vaccinated intramuscularly on days 0, 30, and 180, according to the standard vaccination schedule for hepatitis B vaccines. Serum levels of anti-HBs were measured on days 30, 60, 90, 180, and 210. Standard safety assessments were made throughout the study period. The rates of seroprotection (anti-HBs > or =10.0 mIU/ml) were significantly greater for the AgB/RC-210-04 group at all time points: at day 90, the seroprotection rate, the primary endpoint of the trial, was 99% for AgB/RC-210-04 compared with 84% for AgB (p<0.0001). Similarly, geometric mean anti-HBs titres were significantly higher at all time points for the AgB/RC-210-04 group. There were more local reactions in the AgB/RC-210-04 group, however they were transient and this double-adjuvanted formulation was well tolerated. We conclude that the addition of a synthetic adjuvant to the AgB vaccine significantly enhanced the immunogenicity of the commercial vaccine AgB. The results indicate furthermore that a two-dose regime of the double-adjuvanted vaccine (schedule: 0-1 month) may be sufficient to achieve seroprotection in nearly 100% of individuals.