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1.
New Microbes New Infect ; 48: 101028, 2022 Jul.
Article in English | MEDLINE | ID: mdl-36193102

ABSTRACT

Background: Although anthrax is a rare zoonotic infection, it still causes significant mortality and morbidity. In this multicenter study, which is the largest anthrax case series ever reported, we aimed to describe the factors leading to dissemination of cutaneous anthrax. Methods: Adult patients with cutaneous anthrax from 16 referral centers were pooled. The study had a retrospective design, and included patients treated between January 1, 1990 and December 1, 2019. Probable, and confirmed cases based upon CDC anthrax 2018 case definition were included in the study. A descriptive statistical analysis was performed for all variables. Results: A total of 141 cutaneous anthrax patients were included. Of these, 105 (74%) patients had probable and 36 (26%) had confirmed diagnosis. Anthrax meningitis and bacteremia occurred in three and six patients, respectively. Sequelae were observed in three patients: cicatricial ectropion followed by ocular anthrax (n = 2) and movement restriction on the left hand after surgical intervention (n = 1). One patient had gastrointestinal anthrax. The parameters related to poor outcome (p < 0.05) were fever, anorexia, hypoxia, malaise/fatigue, cellulitis, fasciitis, lymphadenopathy, leukocytosis, high CRP and creatinine levels, longer duration of antimicrobial therapy, and combined therapy. The last two were seemingly the consequences of dissemination rather than being the reasons. The fatality rate was 1.4%. Conclusions: Rapid identification of anthrax is crucial for prompt and effective treatment. Systemic symptoms, disseminated local infection, and high inflammatory markers should alert the treating physicians for the dissemination of the disease.

2.
Nutr Metab Cardiovasc Dis ; 26(11): 1020-1025, 2016 11.
Article in English | MEDLINE | ID: mdl-27511705

ABSTRACT

BACKGROUND AND AIMS: Obesity is predictive of metabolic syndrome (metS), type 2 diabetes, cardiovascular (CV) disease and cancer. The aim of the study is to assess the risk of incident cancer connected to obesity and metS in a Mediterranean population characterized by a high prevalence of obesity. METHODS AND RESULTS: As many as 1133 subjects were enrolled in two phases and followed for 25 years (859 subjects) or 11 years (274 subjects) and incident cancer was registered in the follow-up period. Anthropometric measures and biochemical parameters were filed at baseline and evaluated as predictors of incident cancer by measuring hazards ratios (HR) using multivariate Cox parametric hazards models. Best predictive threshold for metabolic parameters and metS criteria were recalculated by ROC analysis. Fasting Blood Glucose >5.19 mmol/L [HR = 1.58 (1.0-2.4)] and the TG/HDL ratio (log10) (Males > 0.225, Females > 0.272) [HR = 2.44 (1.3-4.4)] resulted independent predictors of survival free of cancer with a clear additive effect together with age classes [45-65 years, HR = 2.47 (1.3-4.4), 65-75 years HR = 3.80 (2.0-7.1)] and male gender [HR = 2.07 (2.3-3.1)]. CONCLUSIONS: Metabolic disturbances are predictive of cancer in a 25 years follow-up of a Mediterranean population following a traditional Mediterranean diet. The high prevalence of obesity and metS and the observed underlying condition of insulin resistance expose this population to an increased risk of cardiovascular disease and cancer despite the healthy nutritional habits.


Subject(s)
Cardiovascular Diseases/epidemiology , Metabolic Syndrome/epidemiology , Neoplasms/epidemiology , Obesity/epidemiology , Aged , Area Under Curve , Biomarkers/blood , Blood Glucose/metabolism , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/prevention & control , Chi-Square Distribution , Diet, Healthy , Diet, Mediterranean , Disease-Free Survival , Female , Humans , Incidence , Insulin Resistance , Italy/epidemiology , Lipids/blood , Male , Metabolic Syndrome/blood , Metabolic Syndrome/diagnosis , Middle Aged , Multivariate Analysis , Neoplasms/diagnosis , Neoplasms/prevention & control , Obesity/diagnosis , Prevalence , Proportional Hazards Models , Protective Factors , ROC Curve , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors
3.
Lett Appl Microbiol ; 63(2): 131-8, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27261362

ABSTRACT

UNLABELLED: We isolated, identified and characterized yeast strains from grapes, and their fermented musts, sampled in the small island of Linosa, where there are no wineries and therefore the possibility of territory contamination by industrial strains is minimal. By traditional culture-dependent methods, we isolated 3805 colonies, distinguished by molecular methods in 17 different species. Five hundred and forty-four isolates were analysed for the main oenological characteristics such as fermentative vigour with and without sulphites, sugar consumption and production of alcohol, volatile acidity, hydrogen sulphide, glycerol and ß-glucosidase. This analysis identified Kluyveromyces marxianus (seldomly used in winemaking) as the most interesting candidate yeast for the production of innovative wines. SIGNIFICANCE AND IMPACT OF THE STUDY: In recent years, interest is growing for wine production by non-Saccharomyces yeasts, both in research and in the industry. This study describes the yeast population of the grapes in a small-secluded island in the Mediterranean Sea, useful site for the search of new strains. Evaluation of fundamental oenological characters identifies potential best yeasts to assay in experimental vinifications. We also describe, for the first time, 14 new colony morphologies on WL Nutrient Agar, culture medium used to monitor the yeast population dynamics.


Subject(s)
Vitis/microbiology , Wine/microbiology , Yeasts/classification , Yeasts/isolation & purification , Ethanol/analysis , Ethanol/metabolism , Fermentation/genetics , Glycerol/analysis , Glycerol/metabolism , Mediterranean Islands , Mediterranean Sea , Molecular Typing , Mycological Typing Techniques , Sulfites/analysis , Sulfites/metabolism , Wine/analysis , Yeasts/genetics
4.
Public Health ; 139: 22-26, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27340042

ABSTRACT

OBJECTIVES: Currently louse-borne relapsing fever (LBRF) is primarily found in limited endemic foci in Ethiopia, Somalia and Sudan; no case of imported LBRF has been reported in Europe in the 9 years prior to 2015. The aim of our paper is to describe a new case of imported LBRF detected in Sicily, Italy, and to review all cases reported in migrants arrived in Europe in the last 10 years. STUDY DESIGN: Mini review of all published cases of louse-borne relapsing fever in Europe in the last 10 years. METHODS: A computerized search without language restriction was conducted using PubMed combining the terms '(louse-borne relapsing fever or LBRF or recurrentis) and (refugee or Europe or migrant)' without limits. Furthermore, the 'Ahead-of-Print Articles' of the top 10 journals (ranked by Impact factor - Web of Science) of Infectious diseases and of Epidemiology were checked. RESULTS: Our search identified 26 cases of LBRF between July and October 2015 in migrants recently arrived in Europe: 8 had been described in Italy; 1 in Switzerland; 2 in the Netherlands; 15 in Germany. We describe data regarding the clinical characteristics, diagnostic methods, therapy and outcome of these patients and of the new case. CONCLUSIONS: LBRF by Borrelia recurrentis should be considered among the clinical hypotheses in migrants presenting with fever, headache, chills, sweating, arthralgia, myalgia, dizziness, nausea and vomiting.


Subject(s)
Borrelia/isolation & purification , Lice Infestations/complications , Relapsing Fever/diagnosis , Transients and Migrants , Adult , Diagnosis, Differential , Humans , Male , Sicily , Somalia/ethnology , Transients and Migrants/statistics & numerical data
5.
Ann Ig ; 27(2): 415-31, 2015.
Article in English | MEDLINE | ID: mdl-26051141

ABSTRACT

Clinical pertussis resulting from infection with B. pertussis is a significant medical and public health problem, despite the huge success of vaccination that has greatly reduced its incidence. The whole cell vaccine had an undeniable success over the last 50 years, but its acceptance was strongly inhibited by fear, only partially justified, of severe side effects, but also, in the Western world, by the difficulty to enter in combination with other vaccines: today multi-vaccine formulations are essential to maintain a high vaccination coverage. The advent of acellular vaccines was greeted with enthusiasm by the public health world: in the Nineties, several controlled vaccine trials were carried out: they demonstrated a high safety and good efficacy of new vaccines. In fact, in the Western world, the acellular vaccines completely replaced the whole cells ones. In the last years, ample evidence on the variety of protection of these vaccines linked to the presence of different antigens of Bordetella pertussis was collected. It also became clear that the protection provided, on average around 80%, leaves every year a significant cohort of vaccinated susceptible even in countries with a vaccination coverage of 95%, such as Italy. Finally, it was shown that, as for the pertussis disease, protection decreases over time, to leave a proportion of adolescents and adults unprotected. Waiting for improved pertussis vaccines, the disease control today requires a different strategy that includes a booster at 5 years for infants, but also boosters for teenagers and young adults, re-vaccination of health care personnel, and possibly of pregnant women and of those who are in contact with infants (cocooning). Finally, the quest for better vaccines inevitably tends towards pertussis acellular vaccines with at least three components, which have demonstrated superior effectiveness and have been largely in use in Italy for fifteen years.


Subject(s)
Pertussis Vaccine/administration & dosage , Vaccines, Acellular/administration & dosage , Whooping Cough/epidemiology , Adolescent , Adult , Humans , Immunization, Secondary , Infant , Italy , Pertussis Vaccine/adverse effects , Time Factors , Vaccination/trends , Vaccines, Acellular/adverse effects , Whooping Cough/prevention & control
6.
Clin Microbiol Infect ; 17(11): E12-5, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21939470

ABSTRACT

In this study 45 isolates of Acinetobacter baumannii identified from patients in intensive care units of three different hospitals and from pressure ulcers in home care patients in Palermo, Italy, during a 3-month period in 2010, were characterized. All isolates were resistant to at least three classes of antibiotics, but susceptible to colistin and tygecycline. Forty isolates were non-susceptible to carbapenems. Eighteen and two isolates, respectively, carried the bla(OXA-23-like) and the bla(OXA-58-like) genes. One strain carried the VIM-4 gene. Six major rep-PCR subtype clusters were defined, including isolates from different hospitals or home care patients. The sequence type/pulsed field gel electrophoresis group ST2/A included 33 isolates, and ST78/B the remaining 12. ST2 clone proved to be predominant, but a frequent involvement of the ST78 clone was evident.


Subject(s)
Acinetobacter Infections/microbiology , Acinetobacter baumannii/isolation & purification , Community-Acquired Infections/microbiology , Cross Infection/microbiology , Acinetobacter baumannii/drug effects , Acinetobacter baumannii/genetics , Anti-Bacterial Agents/pharmacology , Cluster Analysis , Drug Resistance, Multiple, Bacterial , Electrophoresis, Gel, Pulsed-Field , Genotype , Home Care Services , Humans , Intensive Care Units , Italy , Microbial Sensitivity Tests , Molecular Typing , Multilocus Sequence Typing , beta-Lactamases/genetics
7.
Eur J Clin Microbiol Infect Dis ; 28(5): 437-46, 2009 May.
Article in English | MEDLINE | ID: mdl-18958508

ABSTRACT

In a bacterium like Helicobacter pylori, which is characterized by a recombinant population structure, the associated presence of genes encoding virulence factors might be considered an expression of a selective advantage conferred to strains with certain genotypes and, therefore, a potentially useful tool for predicting the clinical outcome of infections. However, differences in the geographical and ethnic prevalence of the H. pylori virulence-associated genotypes can affect their clinical predictive value and need to be considered in advance. In this study we carried out such an evaluation in a group of patients living in Sicily, the largest and most populous island in the Mediterranean Sea. cagA, vacA, babA2, hopQ, oipA, sabA, and hopZ were the H. pylori virulence-associated genes assayed; their presence, expression status or allelic homologs were detected in H. pylori DNA samples and/or isolated strains, obtained by gastric biopsy from 90 Sicilian patients with chronic gastritis, inactive (n = 37), active (n = 26), or active with peptic ulcer (n = 27). Genotypes cagA (+), vacAs1, vacAm1, babA2 (+), and hopQ I, I/II were identified in 51.8, 80.4, 35.2, 47.3, and 67.7% of the different samples respectively. Only these genotypes were associated with each other and with the active form of chronic gastritis, irrespective of the presence of a peptic ulcer. In our isolates their prevalence was more similar to values observed in the north of Italy and France than to those observed in Spain or other Mediterranean countries that are closer and climatically more similar to western Sicily.


Subject(s)
Gastric Mucosa/pathology , Helicobacter Infections/microbiology , Helicobacter Infections/pathology , Helicobacter pylori/genetics , Virulence Factors/genetics , Adult , Aged , Bacterial Proteins/genetics , Biopsy , Gastric Mucosa/microbiology , Gastritis/microbiology , Gastritis/pathology , Gene Expression Profiling , Helicobacter pylori/isolation & purification , Humans , Middle Aged , Sicily
8.
Vaccine ; 27(6): 803-14, 2009 Feb 05.
Article in English | MEDLINE | ID: mdl-19071179

ABSTRACT

An international meeting on Bordetella pertussis assay standardization and harmonization was held at the Centers for Disease Control and Prevention (CDC), Atlanta, GA, 19-20 July 2007. The goal of the meeting was to harmonize the immunoassays used for pertussis diagnostics and vaccine evaluation, as agreed upon by academic and government researchers, regulatory authorities, vaccine manufacturers, and the World Health Organization (WHO). The primary objectives were (1) to provide epidemiologic, laboratory, and statistical background for support of global harmonization; (2) to overview the current status of global epidemiology, pathogenesis and immunology of pertussis; (3) to develop a consensus opinion on existing gaps in understanding standardization of pertussis assays used for serodiagnosis and vaccine evaluation; and (4) to search for a multicenter process for addressing these priority gaps. Presentations and discussions by content experts addressed these objectives. A prioritized list of action items to improve standardization and harmonization of pertussis assays was identified during a group discussion at the end of the meeting. The major items included: (1) to identify a group that will organize, prepare, maintain, and distribute proficiency panels and key reagents such as reference and control sera; (2) to encourage the development and identification of one or more reference laboratories that can serve as an anchor and resource for other laboratories; (3) to define a performance-based assay method that can serve as a reference point for evaluating laboratory differences; (4) to develop guidance on quality of other reagents, e.g., pertussis toxin and other antigens, and methods to demonstrate their suitability; (5) to establish an international working group to harmonize the criteria to evaluate the results obtained on reference and proficiency panel sera; (6) to create an inventory to determine the amount of appropriate and well-characterized sera that are available globally to be used as bridging reagents for vaccine licensure; and (7) to seek specific guidance from regulatory authorities regarding the expectations and requirements for the licensure of new multicomponent pertussis vaccines.


Subject(s)
Bordetella pertussis/immunology , Clinical Laboratory Techniques/standards , Whooping Cough/diagnosis , Whooping Cough/prevention & control , Centers for Disease Control and Prevention, U.S. , Humans , United States , Whooping Cough/epidemiology , Whooping Cough/immunology
9.
Epidemiol Infect ; 136(11): 1576-84, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18198000

ABSTRACT

Humoral and cell-mediated immunity (CMI) against B. pertussis was assessed in a sample of adolescent, adult and senior subjects distributed in five different geographical areas in Italy. Most (99.1%) subjects had IgG anti-pertussis toxin (PT) antibodies exceeding the minimum detection level [> or = 2 ELISA units (EU)/ml]. There were no significant differences between the genders; 6.2% samples recorded titres > or = 100 EU/ml. CMI was positive [stimulation index (SI) > or = 5] against PT in 39.0% of all samples. This study suggests that B. pertussis continues to circulate in age groups that have been previously considered to be uninvolved in the circulation of this pathogen and that adolescent and adult pertussis boosters may be of value in these populations. Nevertheless, over the last 10 years, large increases in vaccination coverage rates have contributed to reduce the spread of the aetiological agent, especially in the immunized population.


Subject(s)
Antibodies, Bacterial/blood , Bordetella pertussis/immunology , Lymphocytes/immunology , Whooping Cough/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Antitoxins/blood , Enzyme-Linked Immunosorbent Assay , Female , Humans , Immunoglobulin G/blood , Italy/epidemiology , Male , Middle Aged , Seroepidemiologic Studies
10.
Eur J Clin Microbiol Infect Dis ; 25(8): 515-7, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16871374

ABSTRACT

Reported here is the case of a 6-week-old female infant with a severe Bordetella pertussis infection requiring supportive pressure-positive ventilation in the intensive care unit. After being discharged from the intensive care unit, she developed hemolytic anemia, thrombocytopenia and acute renal failure, which suggested a diagnosis of hemolytic uremic syndrome. The clinical outcome was favorable with no renal consequences. This case suggests there may be a direct cause-effect relationship between B. pertussis infection and hemolytic uremic syndrome.


Subject(s)
Bordetella pertussis , Hemolytic-Uremic Syndrome/etiology , Whooping Cough/complications , Female , Humans , Infant
11.
Epidemiol Infect ; 134(6): 1208-16, 2006 Dec.
Article in English | MEDLINE | ID: mdl-16690000

ABSTRACT

Studying the epidemiology of pertussis and impact of differing vaccine schedules is difficult because of differing methods of case ascertainment. The advent of internationally standardized serological diagnosis for recent infection has allowed comparison of age-specific pertussis infection among European countries and was applied in Australia at the time of a major national epidemic. In 1997 and 1998, a nationally representative serum bank using residual sera from diagnostic laboratories was established. Measurement of pertussis toxin (PT) IgG level was conducted by a reference laboratory using an enzyme-linked immunosorbent assay standardized for a number of European countries. A titre of 125 EU/ml was interpreted as indicative of recent pertussis infection. The serological data were correlated with age, gender, region and disease epidemiology in Australia. The highest prevalence of recent pertussis infection was in the 5-9 years age group, and the lowest in 1-4 and 25-64 years age groups. In the 5-14 years age group, 29.7% (5-9 years) and 14.6% (10-14 years) of the sample had serological evidence of recent infection, correlating with the pattern of epidemic notifications. The 15- to 24-year-olds had similar high titres but the same notification rate as 25- to 44-year-olds, suggesting ascertainment bias may result in under-notification in the former age group. The prevalence of high titres observed was up to 20-fold higher than some European countries during a similar time period. Although vaccination has reduced the transmission of pertussis in the youngest and most vulnerable age group, pertussis is still endemic in Australia, particularly in older children and the elderly. The Australian vaccination schedule has been changed in an attempt to address this problem, by spacing doses more widely, with the fifth dose at 15-17 years of age. Seroepidemiology for pertussis offers the potential to compare patterns of pertussis between countries and examine the impact of vaccine schedule changes independent of notification and diagnostic bias.


Subject(s)
Bordetella pertussis/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Whooping Cough/epidemiology , Adolescent , Australia/epidemiology , Child , Child, Preschool , Humans , Infant , Population Surveillance , Seroepidemiologic Studies , Whooping Cough/prevention & control
12.
Epidemiol Infect ; 133(1): 159-71, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15724723

ABSTRACT

High titres of pertussis toxin (PT) antibody have been shown to be predictive of recent infection with Bordetella pertussis. The seroprevalence of standardized anti-PT antibody was determined in six Western European countries between 1994 and 1998 and related to historical surveillance and vaccine programme data. Standardized anti-PT titres were calculated for a series of whole-cell and acellular pertussis vaccine trials. For the serological surveys, high-titre sera (> 125 units/ml) were distributed throughout all age groups in both high- (> 90%) and low-coverage (< 90%) countries. High-titre sera were more likely in infants in countries using high-titre-producing vaccines in their primary programme (Italy, 11.5%; Western Germany, 13.3%; France, 4.3%; Eastern Germany, 4.0%) compared to other countries (The Netherlands, 0.5%; Finland, 0%). Recent infection was significantly more likely in adolescents (10-19 years old) and adults in high-coverage countries (Finland, The Netherlands, France, East Germany), whereas infection was more likely in children (3-9 years old) than adolescents in low-coverage (< 90%; Italy, West Germany, United Kingdom) countries. The impact and role of programmatic changes introduced after these surveys aimed at protecting infants from severe disease by accelerating the primary schedule or vaccinating older children and adolescents with booster doses can be evaluated with this approach.


Subject(s)
Whooping Cough/epidemiology , Adolescent , Adult , Antibodies, Bacterial/blood , Bordetella pertussis/immunology , Chi-Square Distribution , Child , Europe/epidemiology , Female , Humans , Immunoglobulin G/blood , Incidence , Male , Pertussis Vaccine/administration & dosage , Prevalence , Seroepidemiologic Studies , Whooping Cough/prevention & control
13.
Vaccine ; 22(1): 112-20, 2003 Dec 08.
Article in English | MEDLINE | ID: mdl-14604578

ABSTRACT

A standardisation process was developed in order to compare and harmonize serological results of pertussis toxin (PT) antibody measurements performed by laboratories using different technical procedures for detection. This involved the development of a common panel, of sera by a designed reference centre, the distribution of the panel to each participating laboratory for testing with their routine methods, the comparison of the obtained results to those of the reference centre, and the calculation of standardisation equations by regressing the quantitative results against those of the reference centre. As a cut-off indicative of protection against pertussis has not yet been defined, a particular emphasis was laid upon achieving standardisation of high titre results that would allow epidemiological evaluations based on the estimation of the incidence of recent infections rather than on the traditional approach of determining the population immunity profile. A generally good agreement was achieved between the participating laboratories, all using ELISA procedures very similar in many crucial aspects, and standardisation equations were produced useful to enable inter-country comparison during the next stages of the European Sero-Epidemiology Network (ESEN) project concerning the serological surveillance of immunity to pertussis in Europe.


Subject(s)
Antibodies, Bacterial/analysis , Whooping Cough/immunology , Adolescent , Calibration , Child , Child, Preschool , Enzyme-Linked Immunosorbent Assay , Europe , Female , Humans , Italy , Male , Reference Standards , Reproducibility of Results
14.
Vaccine ; 21(17-18): 1924-31, 2003 May 16.
Article in English | MEDLINE | ID: mdl-12706678

ABSTRACT

The study of antigen specific IgG subclass distribution during disease, or during any other natural or artificial immunisation, can provide useful information on the kind of the immune response and the expected levels of protection. This is particularly true for diseases, such as pertussis in which the mechanisms underlying specific defence are still not completely understood. An investigation was therefore performed to evaluate the IgG subclass response to pertussis toxin (PT) in sera from 89 healthy vaccinated children and 131 vaccinated or unvaccinated children convalescent after a confirmed B. pertussis symptomatic infection. Antibody titres were expressed in arbitrary ELISA units/ml, and statistical analyses were performed. In unvaccinated convalescent children IgG1 and IgG3 were prevalent whereas in children immunised with two different acellular pertussis (aP) vaccines, both healthy and convalescent, IgG1, IgG2 and IgG4 antibodies were mainly produced. Maintenance of the same anti-PT antibody response pattern in healthy acellular pertussis vaccine recipients and in vaccinated children who later acquire the disease is an interesting result indicative of the priming effect induced by these vaccines in the direction of a relatively higher Th2 cell-polarisation of the immune response.


Subject(s)
Antibodies, Bacterial/blood , Immunoglobulin G/blood , Immunoglobulin G/immunology , Pertussis Toxin/immunology , Pertussis Vaccine/immunology , Whooping Cough/immunology , Bordetella pertussis/immunology , Child , Enzyme-Linked Immunosorbent Assay , Humans , Immunoglobulin G/classification , Reference Values , Whooping Cough/blood
15.
Ann N Y Acad Sci ; 963: 85-90, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12095932

ABSTRACT

The incidence of breast cancer in the city of Palermo and its Province was investigated. The cancer rate was higher in the city of Palermo (100.8/100,000/year), a great southern urban area, than in the 81 municipalities of the Province (79.2/100,000/year). Rates were also compared with those in other geographic areas of Italy, showing a smaller than expected negative north-south gradient in incidence, especially in the young age group, as shown by the cumulative risk observed in the 0-54-year-old group. These findings confirm the role of recent life style changes in the cancer risk distribution.


Subject(s)
Breast Neoplasms/epidemiology , Registries , Adult , Age Distribution , Aged , Breast Neoplasms/therapy , Female , Humans , Incidence , Italy/epidemiology , Middle Aged
16.
Pediatrics ; 108(5): E81, 2001 Nov.
Article in English | MEDLINE | ID: mdl-11694665

ABSTRACT

BACKGROUND: In 1992-1993, a randomized, double-blind, placebo-controlled clinical trial of two 3-component acellular pertussis vaccines was started in 4 of Italy's 20 regions. During the trial, the children had been randomized to receive 3 doses of 1 of 2 acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DT) or of a DT vaccine only, at 2, 4, and 6 months of age. Both diphtheria-tetanus-acellular pertussis (DTaP) vaccines, 1 manufactured by SmithKline Beecham (DTaP SB; Infanrix) and 1 manufactured by Chiron Biocine (DTaP CB; Triacelluvax), contain pertussis toxin (PT), filamentous hemagglutinin, and pertactin. The results of the first period of follow-up, which ended in 1994 (stage 1), showed that both vaccines had a protective efficacy of 84% in the first 2 years of life; when the trial's follow-up was extended under partial blinding until the participating children had reached 33 months of age (stage 2 of the follow-up), these high levels of efficacy had persisted. Therefore, the objective of this study was to estimate the persistence of protection from 3 to 6 years of age of the 2 3-component DTaP vaccines administered as primary immunization in infancy. METHODS: An unblinded prospective longitudinal study of vaccinated and unvaccinated children in 4 Italian regions, with active surveillance of cough, was conducted by study nurses, and Bordetella pertussis infections were confirmed laboratory. The present study (stage 3) included those children who completed stage 2 of the follow-up and were still under active surveillance as of October 1, 1995, accounting for 4217 children who had received DTaP SB (representing 94% of the vaccine's recipients in the initial phase of the trial), 4215 who had received DTaP CB (95% of the original recipients), and 266 who had received DT only (18% of the original recipients). Because the parents of most of the original DT placebo group accepted pertussis vaccination during stage 2 in 1995, an additional 856 children were recruited in the DT group at the initiation of stage 3. These additional children were identified from the census list of children born in the same period and living in the same areas as the trial participants but who had been vaccinated in infancy with DT only. Eligible children were included in stage 3 if they had no history of either pertussis or pertussis vaccination and if a serum sample obtained at the time of enrollment had undetectable immunoglobulin G (IgG) against PT. Parental consent to participate in the study was obtained. Active surveillance for pertussis was conducted in the field by 72 study nurses through monthly contact with each family in the study. A cough episode that lasted >/=7 days was considered to be a laboratory-confirmed infection by Bordetella pertussis if at least 1 of the following 5 criteria (listed in hierarchic order) was met: 1) B pertussis was obtained from nasopharyngeal culture (culture-confirmed infection); 2) the enzyme-linked immunosorbent assay (ELISA) IgG or IgA titer against PT in the convalescent-phase serum sample increased by at least 100% compared with the acute-phase sample; 3) the PT-neutralizing titers in Chinese hamster ovary assay in the convalescent-phase sample increased by at least 4-fold compared with the acute-phase sample; 4) the ELISA IgG or IgA titer against filamentous hemagglutinin in the convalescent-phase sample increased by at least 100% and the culture or the polymerase chain reaction assay on the nasopharyngeal aspirate was negative for B parapertussis; and 5) the ELISA IgG PT titer in 1 of the 2 serum samples exceeded the geometric mean titer computed on convalescent sera of the children with a culture-confirmed B pertussis infection in each study group. Incidence of laboratory-confirmed B pertussis infection, using case definitions that varied in terms of duration and type of cough, was computed and the proportion of cases prevented among DTaP recipients in comparison with DT recipients was calculated. RESULTS: A total of 391 laboratory-confirmed infections were identified in the 3-year follow-up period (138 DTaP SB, 126 DTaP CB, 127 DT recipients, respectively). The mean duration of cough in children with laboratory-confirmed infection was 48, 47, and 70 days for the DTaP SB, DTaP CB, and DT recipients, respectively; the mean duration of spasmodic cough was 15, 13, and 23 days, respectively. When using the primary case definition (ie, laboratory-confirmed B pertussis infection and >/=14 days of spasmodic cough or >/=21 days of any cough), the efficacy was 78% for the DTaP SB vaccine (95% confidence interval [CI]: 71%-83%) and 81% for the DTaP CB vaccine (95% CI: 74%-85%). When using the case definition based on a more severe clinical presentation (>/=21 days of spasmodic cough), the vaccine efficacy was 86% (95% CI: 79%-91%) for both vaccines. When using the case definition based on milder clinical presentation (any cough for >/=7 days), the efficacy was 76% (95% CI: 69%-81%) for the DTaP SB vaccine and 78% (95% CI: 72%-83%) for the DTaP CB vaccine. CONCLUSIONS: The persistence of protection through 6 years of age suggests that the fourth DTaP dose could be postponed until preschool age in children who received 3-component acellular pertussis vaccines in infancy, provided that immunity to diphtheria and tetanus is maintained. Additional booster doses could be administered at older ages to reduce reactogenicity induced by multiple administrations and to optimize the control of pertussis in adolescents and young adults.


Subject(s)
Bordetella pertussis/immunology , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Whooping Cough/immunology , Age Factors , Antibodies, Bacterial/blood , Bordetella pertussis/isolation & purification , Child , Child, Preschool , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Double-Blind Method , Female , Follow-Up Studies , Humans , Immunization Schedule , Immunoglobulin A/blood , Immunoglobulin G/blood , Incidence , Italy/epidemiology , Male , Population Surveillance , Whooping Cough/epidemiology , Whooping Cough/prevention & control
17.
Infect Immun ; 69(7): 4516-20, 2001 Jul.
Article in English | MEDLINE | ID: mdl-11401994

ABSTRACT

The aim of this study was to compare pertussis-specific humoral and cellular immunity in children 5 years after a primary vaccination with a combined diphtheria, tetanus, tricomponent acellular pertussis, and hepatitis B vaccine (DTaP-HBV; InfanrixHepB; SmithKline Beecham) with immunity after natural infection. The subjects were 38 children aged 5 to 6 years who received DTaP-HBV at 3, 5, and 11 months of life and 21 subjects of similar ages and sex who acquired pertussis in the first year of life. Immunoglobulin G (IgG) antibody titers against Bordetella pertussis antigens, peripheral blood mononuclear cell-specific proliferation, and the secretion of cytokines were evaluated. After 5 years, only a small proportion of vaccinated and infected children had significant specific concentrations of IgG in serum against all three B. pertussis antigens, and T-cell responses persisted in a minority of subjects. A preferential type 1 cytokine response with the secretion of gamma interferon was observed in the pertussis group, whereas a type 2 skewed response was observed in the vaccinated children; however, the quantitative differences in the cytokines produced by DTaP-HBV and natural infection were minimal. In conclusion, our results show that the immune responses induced by primary pertussis vaccination are qualitatively and quantitatively similar to those seen in children who recovered from natural infection and highlight the need for booster immunization with pertussis vaccines in order to maintain adequate levels of a specific immune response to B. pertussis.


Subject(s)
Bordetella pertussis/immunology , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/immunology , Whooping Cough/immunology , Antibodies, Bacterial/blood , Cell Division , Child , Child, Preschool , Female , Humans , Interferon-gamma/biosynthesis , Interleukin-2/biosynthesis , Interleukin-4/biosynthesis , Interleukin-5/biosynthesis , Lymphocytes/cytology , Lymphocytes/immunology , Male , Single-Blind Method , Time Factors , Vaccination , Vaccines, Combined/immunology , Whooping Cough/blood , Whooping Cough/prevention & control
18.
Pediatrics ; 107(2): E25, 2001 Feb.
Article in English | MEDLINE | ID: mdl-11158499

ABSTRACT

OBJECTIVES: To determine the reactogenicity and immunogenicity of a fourth dose of 2 three-component acellular pertussis vaccines combined with diphtheria-tetanus-acellular pertussis (DTaP) when administered at preschool age to children primed in infancy with 3 doses of the same DTaP and who had received a diphtheria-tetanus (DT) dose at the age of 12 months. SETTING: Local health units of 4 Italian regions. STUDY DESIGN: Three thousand five hundred twenty-two children, who had been randomized in the first year of life to be immunized with a DTaP vaccine by either SmithKline Beecham or Chiron Biocine, were offered a booster of the same vaccine or, if refusing, a DT vaccine at the age of 5 to 6 years. Families of children were aware of the vaccine administered. The occurrence of adverse events was compared between the children who received a DTaP booster and those boosted with a DT only. Antibody titers to pertussis vaccine components (pertussis toxin, filamentous hemoagglutinin, and pertactin) were determined on 558 paired sera taken before and 30 days after the DTaP booster administration. RESULTS: Four episodes of temperature >/=39.5 degrees C, 2 in each DTaP group, were recorded. Fever >/=38 degrees C occurred infrequently in both DTaP and DT recipients (DTaP range: 2.5%-2.8%; DT range: 0%-4.8%), as did irritability (DTaP range: 10.1%-11.7%; DT range: 7.4%-12.6%). The frequency of local reactions was significantly higher for DTaP recipients (range: 44.0%-52.8%), with respect to DT recipients (range: 29.5%-44.4%). Extensive local reactions were observed in 1.2% of DTaP recipients and in.5% of DT recipients. Both DTaP vaccines induced high antibody titers against pertussis toxin, filamentous hemoagglutinin, and pertactin, with an increase of >10 times the prebooster geometric mean titers. CONCLUSIONS: A booster dose of DTaP at preschool age in children primed with the same acellular pertussis vaccine is safe and immunogenic. However, the frequency of local reactions is higher compared with that following primary immunization and with that following booster with DT only, and parents should be informed of the potential for these reactions to occur.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Immunization, Secondary/adverse effects , Child , Child, Preschool , Diphtheria-Tetanus Vaccine/adverse effects , Diphtheria-Tetanus Vaccine/immunology , Female , Humans , Injections , Italy , Male , Prospective Studies
19.
Acta Otorhinolaryngol Ital ; 20(2): 121-4, 2000 Apr.
Article in Italian | MEDLINE | ID: mdl-10992604

ABSTRACT

The authors report a case of congenital central hypoventilation syndrome (CCHS) studied from the otoneurological point of view. Emphasis is placed on the numerous alterations in the electronystagmograph and auditory potentials. The results obtained confirm the hypothesis that such patients are subject to CNS alterations, suggesting that the disease pathogenesis derives from an alteration in the mechanism of central chemoreceptor stimuli integration.


Subject(s)
Sleep Apnea, Central/congenital , Sleep Apnea, Central/diagnosis , Chemoreceptor Cells/physiology , Child , Electronystagmography/methods , Evoked Potentials, Auditory/physiology , Evoked Potentials, Auditory, Brain Stem/physiology , Hearing Loss, Conductive/diagnosis , Humans , Male , Saccades/physiology , Severity of Illness Index
20.
Vaccine ; 17(15-16): 2030-5, 1999 Apr 09.
Article in English | MEDLINE | ID: mdl-10217603

ABSTRACT

The reactogenicity of a three-dose catch-up acellular pertussis (aP) immunization of children at 21-40 months of age was evaluated. Vaccination was well-tolerated: fever > or = 38 degrees C was reported after 5% of administered doses and local reactions after 14-15%. The onset of adverse events was not associated with age at vaccination, interval between doses or previous presence of antibodies against pertussis, whereas injection in sites other than the buttock and presence of the same symptom after a previous dose were associated with higher reactogenicity. Because of the good safety profile of primary aP immunization in children > 1 year of age, catch-up vaccination campaigns could be considered in areas where pertussis whole-cell vaccination uptake has been low and where the number of susceptible children should be reduced to control pertussis circulation.


Subject(s)
Immunization Schedule , Pertussis Vaccine/administration & dosage , Pertussis Vaccine/adverse effects , Aging , Antibodies, Bacterial/blood , Antibodies, Bacterial/immunology , Bordetella pertussis/immunology , Child, Preschool , Dose-Response Relationship, Immunologic , Female , Humans , Immunoglobulin G/blood , Immunoglobulin G/immunology , Infant , Male , Pertussis Vaccine/immunology , Vaccination
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