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1.
ESMO Open ; 7(2): 100457, 2022 04.
Article En | MEDLINE | ID: mdl-35366489

BACKGROUND: Cancer-related fatigue (CRF) is common in patients with advanced solid tumors and several risk factors are described. The possible role of depression is reported by clinicians despite the association with CRF being unclear. MATERIAL AND METHODS: In this monocentric, cross-sectional, prospective study we recruited patients with advanced solid tumors who were hospitalized at Fondazione IRCCS Istituto Nazionale dei Tumori of Milan. The primary objective was to assess the correlation between CRF and depression. Secondary objectives were the estimation of CRF and depression prevalence and the identification of associated clinical risk factors. CRF and depression were evaluated through the Functional Assessment of Cancer Therapy-Fatigue subscale and the Zung Self Depression Scale (ZSDS) questionnaires. The Cochran-Armitage trend test was used to demonstrate the primary hypothesis. Univariate and multivariate logistic regression models were used to investigate the impact of clinical variables. RESULTS: A total of 136 patients were enrolled. The primary analysis found a linear correlation (P < 0.0001) between CRF and depression. The prevalence of CRF and of moderate to severe depressive symptoms was 43.5% and 29.2%, respectively. In univariate analysis, patients with poor Eastern Cooperative Oncology Group performance status (ECOG PS), anemia, distress, pain, and receiving oncological treatment were at a significantly higher risk for CRF, whereas poor ECOG PS, pain, and distress were risk factors for depression. In multivariate analysis, high levels of ZSDS were confirmed to be correlated to CRF: odds ratio of 3.86 [95% confidence interval (CI) 0.98-15.20) and 11.20 (95% CI 2.35-53.36) for ZSDS of 50-59 and 60-100, respectively (P value for trend 0.002). Moreover, the ECOG PS score was confirmed to be significantly associated with CRF (OR 7.20; 95% CI 1.73-29.96; P = 0.007). CONCLUSIONS: Our data suggest a strong correlation between CRF and depression in patients with advanced solid tumors. Further investigations are needed to better understand this relationship and if depressive disorder therapeutic strategies could also impact on CRF.


Depression , Neoplasms , Cross-Sectional Studies , Depression/epidemiology , Depression/etiology , Fatigue/epidemiology , Fatigue/etiology , Humans , Neoplasms/complications , Neoplasms/epidemiology , Pain/complications , Prospective Studies , Quality of Life
2.
Eur J Paediatr Dent ; 18(2): 158-162, 2017 Jun.
Article En | MEDLINE | ID: mdl-28598189

AIM: The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) is a valid tool aiming to evaluate the self-reported influence of dental aesthetics on quality of life. This questionnaire was developed in English for young adults, and later translated and validated with an Italian population. A new version of the questionnaire was recently introduced to be used in adolescents (11-17 years- old), but it had not been translated in Italian yet. Hence, the purpose of this study was to translate, cross-culturally adapt and validate the PIDAQ for adolescents, for its use among Italian subjects. METHODS: To develop the Italian PIDAQ, the original version was translated, back-translated, cross-culturally adapted and pre-tested. Afterwards, the Italian PIDAQ was administered to a convenience sample of 677 subjects, aged 11-17 years, together with two other written questionnaires: the Aesthetic Component of the Index of Orthodontic Treatment Need (IOTN-AC) and the Perception of Occlusion Scale (POS), which are instruments dedicated to assess the self-reported degree of malocclusion. A one-way ANOVA was performed to assess the difference between groups, within each PIDAQ factor, according to POS and IOTN-AC scores. The correlation between PIDAQ factors and POS/IOTN-AC scores was measured as Spearman's rank correlation. The internal consistency was assessed as Cronbach's alpha coef?cient (α), and the test-retest reproducibility as Intra-Class Correlation Coef?cient (ICC). RESULTS: The one-way ANOVA showed that all the factors of the self- reported impact of dental aesthetics on quality of life significantly increased as the degree of malocclusion worsened (P<0.001). Furthermore, all the factors showed statistically significant correlations with both IOTN-AC and POS scores. The α ranged between 0.79 and 0.90, and the ICC ranged between 0.93-0.97. CONCLUSION: The Italian adolescent PIDAQ showed good reliability and validity. The psychometric properties of this version of the questionnaire support its use for the assessment of the psychosocial impact of dental aesthetics among Italian adolescents.


Esthetics, Dental/psychology , Quality of Life , Surveys and Questionnaires , Adolescent , Cross-Cultural Comparison , Female , Humans , Index of Orthodontic Treatment Need , Italy , Male , Psychometrics , Self Report , Translating
3.
Minerva Pediatr ; 66(5): 381-414, 2014 Oct.
Article It | MEDLINE | ID: mdl-25253187

Obesity in childhood is associated with the presence of complications that can undermine health immediately or in the long term. Several conditions, such as pulmonary or orthopedic complications are strictly associated with the severity of overweight, since they are directly associated to the mechanic stress of fat tissue on the airways or on the bones. Other conditions, such as metabolic or liver complications, although increasing with the extent of overweight, are associated with insulin resistance, which can be modulated by different other factors (ethnicity, genetics, fat distribution) and can occur in overweight children as well. No less important are psychological correlates, such as depression and stigma, which can seriously affect the health related quality of life. Pediatric services for the care of childhood obesity need to be able to screen overweight and obese children for the presence of physical and psychological complications, which can be still reversed by weight loss. This article provides pediatricians a comprehensive update on the main complications in obese children and adolescents and their treatment.


Cardiovascular Diseases/etiology , Depression/etiology , Health Status , Insulin Resistance , Musculoskeletal Diseases/etiology , Obesity/complications , Respiratory Tract Diseases/etiology , Adolescent , Behavior Therapy , Body Mass Index , Cardiovascular Diseases/epidemiology , Child , Counseling , Depression/epidemiology , Diabetes Complications/epidemiology , Humans , Italy/epidemiology , Life Style , Musculoskeletal Diseases/epidemiology , Obesity/epidemiology , Obesity/therapy , Overweight/complications , Prevalence , Respiratory Tract Diseases/epidemiology , Risk Factors , Weight Loss
4.
Minerva Pediatr ; 64(4): 413-31, 2012 Aug.
Article It | MEDLINE | ID: mdl-22728613

Obesity is a complex public health issue. Recent data indicate the increasing prevalence and severity of obesity in children. Severe obesity is a real chronic condition for the difficulties of long-term clinical treatment, the high drop-out rate, the large burden of health and psychological problems and the high probability of persistence in adulthood. A staged approach for weight management is recommended. The establishment of permanent healthy lifestyle habits aimed at healthy eating, increasing physical activity and reducing sedentary behavior is the first outcome, because of the long-term health benefits of these behaviors. Improvement in medical conditions is also an important sign of long-term health benefits. Rapid weight loss is not pursued, for the implications on growth ad pubertal development and the risk of inducing eating disorders. Children and adolescents with severe obesity should be referred to a pediatric weight management center that has access to a multidisciplinary team with expertise in childhood obesity. This article provides pediatricians a comprehensive and evidence based update on treatment recommendations of severe obesity in children and adolescents.


Behavior Therapy , Diet, Reducing , Exercise , Obesity, Morbid/therapy , Weight Loss , Adolescent , Behavior Therapy/methods , Body Mass Index , Child , Evidence-Based Medicine , Humans , Italy/epidemiology , Life Style , Obesity, Morbid/diagnosis , Obesity, Morbid/epidemiology , Prevalence , Severity of Illness Index , Treatment Outcome
5.
Br J Ophthalmol ; 90(11): 1354-6, 2006 Nov.
Article En | MEDLINE | ID: mdl-16899529

BACKGROUND: The early microbiological diagnosis of corneal infections may prevent the condition from worsening. AIM: To study the potential interferences of oxybuprocain and fluorescein solutions used by ophthalmologists on the performances of the real-time polymerase chain reaction (PCR) carried out as routine test for diagnosis of keratitis. METHODS: Quantified suspensions of Herpes simplex virus (HSV1), Varicella zoster virus (VZV), Cytomegalovirus (CMV) and Acanthamoeba with and without oxybuprocain or fluorescein added before DNA extraction were tested by real-time PCR. RESULTS: The capacities of the real-time PCR to detect HSV, VZV, CMV and Acanthamoeba were reduced by oxybuprocain and fluorescein. Both products diluted to 1/16 reduced the PCR detection capacities for more than 2 logs (DNA copies/sample). CONCLUSIONS: The simultaneous introduction of fluorescein or topical anaesthetics into the tubes containing the specimens to be tested by PCR may lead to false negative results. Because corneal specimens for microbiological diagnosis of keratitis are obtained after topical administration of anaesthetics and corneal staining with fluorescein, ophthalmologists should be aware to rinse the eye surface intensively with appropriate eye solutions to minimise the risks of misdiagnosis.


Anesthetics, Local/pharmacology , Eye Infections, Viral/diagnosis , Fluorescein/pharmacology , Fluorescent Dyes/pharmacology , Keratitis/diagnosis , Reverse Transcriptase Polymerase Chain Reaction , Acanthamoeba/genetics , Acanthamoeba Keratitis/diagnosis , Animals , Cytomegalovirus/genetics , DNA, Protozoan/analysis , DNA, Viral/analysis , Eye Infections, Viral/microbiology , Herpesviridae/genetics , Herpesvirus 1, Human/genetics , Herpesvirus 3, Human/genetics , Humans , Keratitis/microbiology , Keratitis, Herpetic/diagnosis , Procaine/analogs & derivatives , Procaine/pharmacology , Sensitivity and Specificity
6.
G Ital Med Lav Ergon ; 27(3): 303-7, 2005.
Article It | MEDLINE | ID: mdl-16240580

Asphalt is a mixture of mineral matter and bitumen, its fumes contain about 1% of Polycyclic Aromatic Hydrocarbons (PAH), some of which are carcinogens. In the PPTP-POPA Study of Lombardy Region, a group of 100 asphalt workers (exposed to bitumen fumes and diesel exhausts) and a group of 47 ground construction operators (exposed only to diesel exhausts) were investigated to assess PAH exposure in Italy, by means of environmental-air monitoring (the 16 most relevant, according to the American Environmental Protection Agency, EPA) and biological monitoring (urinary 1-hydroxypyrene excretion). Our results show that PAH exposure in these workers is not higher than that observed in traffic policemen working in urban areas. Since dermal exposure has been suggested as a major determinant of the total PAH dose absorbed by road pavers from bitumen fumes, we assessed skin contamination by organic aromatic compounds and by sixteen PAH: in both groups, six pads were applied to each subject in different parts of the body, during the workshift. The results show that the dermal contamination in road pavers is higher than in ground construction operators and that cutaneous dose rate is higher than respiratory dose rate, whereas the amount of absorption the ratio is inverted.


Environmental Monitoring , Hydrocarbons/adverse effects , Inhalation Exposure , Occupational Exposure , Polycyclic Aromatic Hydrocarbons/adverse effects , Vehicle Emissions/adverse effects , Adult , Chromatography, High Pressure Liquid , Humans , Hydrocarbons/administration & dosage , Italy , Male , Polycyclic Aromatic Hydrocarbons/administration & dosage , Pyrenes/analysis , Skin/drug effects
7.
J Fr Ophtalmol ; 27(3): 239-48, 2004 Mar.
Article Fr | MEDLINE | ID: mdl-15039625

PURPOSE: To study acute-angle-closure glaucoma (AACG) biometry using Orbscan and echography. MATERIAL AND METHODS: We prospectively studied 200 normal eyes of 100 patients (including eyes with ametropia), 50 eyes of 25 patients before peripherial YAG laser iridotomy, 25 phakic eyes of 25 patients with a history of acute-angle-closure glaucoma (AACG) in the fellow eye. Both plane and polynomial modes of reconstruction of the iridocorneal angle measurement were analyzed. Biometric measurements of the three groups were compared. Biometric measurements (i.e., iridocorneal angle, anterior chamber depth, axial length, and lens thickness) and subjective spherical equivalent were correlated with the etiological classification. RESULTS: Age, sex, iridocorneal angle, anterior chamber depth, lens thickness, axial length and subjective spherical equivalent were significantly different in the three groups (p<0.002). The polynomial iridocorneal angle measurement was 43.4 degrees in the normal group, 36.5 degrees in the iridotomy group, and 28.4 degrees in the AACG group (p<0.001). Iridocorneal angle measurement correlated with the other biometric measurements (rs>0.51; p<0.001) and with the etiological classification (rs< or =0.68; p<0.001). The anterior chamber depth measurement obtained by Orbscan or echography was the best parameter for predicting ACCG (rs=0.77; p<0.001). CONCLUSION: The anterior chamber depth and polynimial iridocorneal angle obtained using the Orbscan device appears to be useful in predicting acute-angle-closure glaucoma.


Glaucoma, Angle-Closure/diagnostic imaging , Glaucoma, Angle-Closure/pathology , Acute Disease , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Ultrasonography
8.
Biotechnol Prog ; 18(5): 975-85, 2002.
Article En | MEDLINE | ID: mdl-12363348

The effect of methanol on the kinetically controlled synthesis of cephalexin by free and immobilized penicillin G acylase (PGA) was investigated. Catalytic and hydrophobic membranes were obtained by chemical grafting, activation, and PGA immobilization on hydrophobic nylon supports. Butyl methacrylate (BMA) was used as graft monomer. Increasing concentrations of methanol were found to cause a greater deleterious effect on the activity of free than on that of the immobilized enzyme. Methanol, however, improved the kinetic stability of cephalexin synthesized by free PGA, resulting in higher maximum yields. By contrast, immobilized PGA reached 100% yields even in the absence of the cosolvent. Cephalexin synthesis by the catalytic membrane was also performed in a non-isothermal bioreactor. Under these conditions, a 94% increase of the synthetic activity and complete conversion of the limiting substrate to cephalexin were obtained. The addition of methanol reduced the non-isothermal activity increase. The physical cause responsible for the non-isothermal behavior of the hydrophobic catalytic membrane was identified in the process of thermodialysis.


Cephalexin/chemical synthesis , Membranes, Artificial , Methanol/chemistry , Penicillin Amidase/chemistry , Temperature , Water/chemistry , Anti-Bacterial Agents/chemical synthesis , Bioreactors , Catalysis , Cephalosporins/chemistry , Enzyme Activation , Enzymes, Immobilized/chemistry , Escherichia coli/enzymology , Hydrophobic and Hydrophilic Interactions , Methacrylates/chemistry , Nylons , Penicillin Amidase/metabolism , Propylene Glycols/chemistry , Sensitivity and Specificity
9.
Biotechnol Bioeng ; 79(3): 334-46, 2002 Aug 05.
Article En | MEDLINE | ID: mdl-12115422

A new hydrophobic and catalytic membrane was prepared by immobilizing Penicillin G acylase (PGA, EC.3.5.1.11) from E. coli on a nylon membrane, chemically grafted with butylmethacrylate (BMA). Hexamethylenediamine (HMDA) and glutaraldehyde (Glu) were used as a spacer and coupling agent, respectively. PGA was used for the enzymatic synthesis of cephalexin, using D(-)-phenylglycine methyl ester (PGME) and 7-amino-3-deacetoxycephalosporanic acid (7-ADCA) as substrates. Several factors affecting this reaction, such as pH, temperature, and concentrations of substrates were investigated. The results indicated good enzyme-binding efficiency of the pre-treated membrane, and an increased stability of the immobilized PGA towards pH and temperature. Calculation of the activation energies showed that cephalexin production by the immobilized biocatalyst was limited by diffusion, resulting in a decrease of enzyme activity and substrate affinity. Temperature gradients were employed as a way to reduce the effects of diffusion limitation. Cephalexin was found to linearly increase with the applied temperature gradient. A temperature difference of about 3 degrees C across the catalytic membrane resulted into a cephalexin synthesis increase of 100% with a 50% reduction of the production times. The advantage of using non-isothermal bioreactors in biotechnological processes, including pharmaceutical applications, is also discussed.


Anti-Bacterial Agents/chemical synthesis , Bioreactors , Cephalexin/chemical synthesis , Membranes, Artificial , Nylons , Penicillin Amidase/chemistry , Catalysis , Cephalosporins/chemistry , Coated Materials, Biocompatible , Enzymes, Immobilized , Equipment Design , Escherichia coli/enzymology , Hydrogen-Ion Concentration , Hydrophobic and Hydrophilic Interactions , Methacrylates , Models, Chemical , Propylene Glycols/chemistry , Sensitivity and Specificity , Temperature
10.
J Fr Ophtalmol ; 25(9): 879-88, 2002 Nov.
Article Fr | MEDLINE | ID: mdl-12515931

PURPOSE: To evaluate amniotic membrane transplantation (AMT) in severe corneal epithelial diseases. METHODS: Amniotic membrane transplantation was performed in 14 eyes of 14 patients from four groups: A, five severe ocular burns; B, four cases of cicatricial keratoconjunctivitis; C, three persistent epithelial defects after penetrating keratoplasty; D, two cases of pseudophakic bullous keratopathy. Five patients underwent AMT alone; two patients underwent AMT combined with limbal transplantation; the other three patients had limbal transplantation performed before AMT. Eight patients required combined penetrating keratoplasty. Patients with corneal stable reepithelialization, no corneal neovascularization, and no recurrence of the initial pathology were considered successful. RESULTS: The mean follow-up was 7+/-3 months. All but three patients underwent corneal reepithelialization within 6 weeks of AMT, with a mean healing time of 31+/-23 days. The success rate was 75% at 6 months (Kaplan-Meier method). Three of four procedures in group B failed. In eight patients, visual acuity improved, in one it worsened, and in the last five patients it remained unchanged. Visual acuity increased by an average of 7+/-9 lines. CONCLUSION: AMT is a useful technique for ocular surface reconstruction, especially in association with limbal transplantation. It could also improve the prognosis of penetrating keratoplasty in patients with severe corneal conditions.


Amnion/transplantation , Corneal Diseases/surgery , Corneal Transplantation , Epithelium, Corneal , Eye Burns/surgery , Keratoconjunctivitis/surgery , Adolescent , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Keratoplasty, Penetrating/adverse effects , Limbus Corneae , Male , Middle Aged , Time Factors
11.
Pediatr Infect Dis J ; 17(10): 913-8, 1998 Oct.
Article En | MEDLINE | ID: mdl-9802635

AIM: To determine whether an oral tetravalent rotavirus vaccine (RV-TV) can be safely coadministered with a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine (DTP/Hib) and oral poliovirus vaccine (OPV) to healthy infants without interfering with the immune responses to any of the component antigens. METHODS: Two hundred sixty-seven infants ages 2 to 3 months were randomly assigned in a double blind fashion to receive three doses of either placebo or RV-TV, each containing 4 x 10(5) plaque-forming units, concurrently with DTP/ Hib (Tetramune) and OPV at approximately 2, 4 and 6 months of age. Infants were followed for 5 days after each dose for the occurrence of adverse events and subsequently until 3 to 6 weeks after the third dose of RV-TV or placebo. Immune responses were assessed by measuring the postvaccination serum antibody titers to each component of DTP/ Hib and OPV at 3 to 6 weeks after the third dose. RESULTS: The percentage of infants who attained protective antibody titers and the distribution of antibody titers against diphtheria toxoid, tetanus toxoid and H. influenzae type b were not statistically different between RV-TV and placebo recipients. The distribution of antibody titers against different antigens of Bordetella pertussis (agglutinins, pertussis toxoid, filamentous hemagglutinin, fimbriae antigens and the 69-kDa outer membrane protein) was compared and no significant differences were found. The percentage of infants with detectable neutralizing antibodies against the three serotypes of poliovirus and the distribution of antibody titers was not statistically different between RV-TV and placebo recipients. There were no clinically meaningful differences in postvaccination reactions between RV-TV and placebo recipients. CONCLUSIONS: Three doses of RV-TV can be safely coadministered with three doses of DTP/ Hib and OPV without diminishing an infant's serum antibody responses to each component of these vaccines. Therefore RV-TV can be given at the standard childhood visits at 2, 4 and 6 months of age.


Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Haemophilus Vaccines/administration & dosage , Poliovirus Vaccine, Oral/administration & dosage , Rotavirus Vaccines , Rotavirus/immunology , Viral Vaccines/administration & dosage , Antibodies, Bacterial/biosynthesis , Antibodies, Viral/biosynthesis , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Double-Blind Method , Female , Haemophilus Vaccines/immunology , Humans , Immunization Schedule , Infant , Male , Poliovirus Vaccine, Oral/immunology , Vaccines, Attenuated/administration & dosage , Vaccines, Attenuated/immunology , Vaccines, Combined/immunology , Viral Vaccines/immunology
12.
Pediatr Infect Dis J ; 17(5): 386-90, 1998 May.
Article En | MEDLINE | ID: mdl-9613651

BACKGROUND: The tetravalent rhesus rotavirus vaccine (RV-TV) has been administered to several thousand children in multiple settings throughout the world. It has been proved safe and efficacious, resulting in an application for licensure in 1997. However, only limited information has been reported on viral shedding after RV-TV vaccination. METHODS: Stool specimens were collected between Days 3 and 5 after administration of each of 3 doses of RV-TV to 248 subjects 6 to 12 weeks of age in 8 centers across the United States. Rotavirus antigen was measured by an enzyme-linked immunosorbent assay to determine the number of subjects who shed after each dose. The relative quantities of vaccine strains shed were then determined by plaque purification and serotype analysis. RESULTS: Rotavirus shedding was detected in 125 (50.4%) subjects, and 19 shed after more than 1 dose. Although fewer subjects shed rotavirus after Dose 2 (14.5%), shedding after Doses 1 (26.0%) and 3 (22.5%) were comparable. After plaque purification and serotyping, most viruses shed (76.2%) were identified as G3 after Dose 1, but a major shift to G2 strains was found after Doses 2 (61.3%) and 3 (69.0%). CONCLUSIONS: Sequential RV-TV administrations caused no overall significant decrease in the number of vaccinees who experienced detectable shedding. A major shift in shedding was found from the serotype G3 vaccine strain (RRV) after the first dose of vaccine to the serotype G2 reassortant after Doses 2 and 3.


Rotavirus Vaccines , Rotavirus/physiology , Viral Vaccines/administration & dosage , Virus Shedding/immunology , Humans , Infant , Polymerase Chain Reaction , Rotavirus/immunology , Rotavirus/isolation & purification , Viral Plaque Assay
13.
J Pediatr ; 131(4): 632-8, 1997 Oct.
Article En | MEDLINE | ID: mdl-9386673

OBJECTIVES: We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons. STUDY DESIGN: Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 10(5) plaque-forming units per dose), RRV-S1 (4 x 10(5) plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol. RESULTS: During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (-4, 75) for RRV-S1. CONCLUSIONS: These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.


Indians, North American , Rotavirus Infections/prevention & control , Rotavirus Vaccines , Vaccines, Attenuated/administration & dosage , Viral Vaccines/administration & dosage , Double-Blind Method , Gastroenteritis/diagnosis , Humans , Infant , Retrospective Studies , Rotavirus Infections/immunology , Severity of Illness Index , Vaccines, Attenuated/adverse effects , Viral Vaccines/adverse effects
14.
J Infect Dis ; 176(3): 570-7, 1997 Sep.
Article En | MEDLINE | ID: mdl-9291301

The correlation of antibody responses (serum rotavirus IgA and neutralizing antibody to serotype G1-G4 human rotaviruses and rhesus rotavirus [RRV]) in a reassortant rotavirus vaccine trial with protection against rotavirus infection or disease was investigated. Most subjects administered 4 x 10(5) pfu of either the serotype G1 monovalent or serotype G1-G4 tetravalent vaccine seroconverted for at least one of the six antibodies (85% and 91%, respectively). However, fewer than one-third seroconverted to any prototype G1-G4 human rotavirus. Analyses of covariance indicated that higher prevaccination neutralizing antibody titers negatively affected postvaccination titers. Significant relationships were found between several postvaccination rotavirus antibody titers and protection, and serotype-specific correlates of protection were identified between anti-Wa titers and G1 illnesses (P = .03) and between anti-RRV titers and G3 illnesses (P < .001). Overall, however, serotype-specific immunity was no more significant than heterotypic immunity, and no specific titer of any antibody analyzed was a reliable indicator of protection.


Reassortant Viruses/immunology , Rotavirus Infections/prevention & control , Rotavirus/immunology , Viral Vaccines/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , Humans , Immunity , Incidence , Infant , Rotavirus Infections/epidemiology , Vaccination
15.
Pediatr Infect Dis J ; 15(11): 1012-8, 1996 Nov.
Article En | MEDLINE | ID: mdl-8933551

OBJECTIVE: To compare the safety and immunogenicity of two dosages of tetravalent rhesus rotavirus vaccine (RRV-TV) and the effect of age at dosing. METHODS: A total of 195 infants were stratified by age into 2 groups, 6 to 12 weeks and 16 to 24 weeks, and randomly assigned to receive a single dose of placebo or RRV-TV containing either 4 x 10(5) or 4 x 10(6) plaque-forming units (pfu). Symptoms were recorded for 5 days after vaccination. Anti-rotavirus IgA and neutralizing antibody to human rotavirus serotypes G1 to G4 and RRV were measured in serum obtained pre- and postvaccination. RESULTS: Rates of fever > 38 degrees C (9%), diarrhea (6%) and vomiting (8%) were similar in all groups. IgA (69% vs. 49%, P = 0.02) and RRV (85% vs. 66%, P = 0.004) seroconversion rates were significantly higher in the 4 x 10(6) pfu vaccine group as were antibody titers to RRV (440.2 vs. 263.7, P = 0.04). Older infants demonstrated significantly higher seroconversion rates and antibody titers for IgA (71% vs. 52%, P = 0.03; and 110.6 vs. 54.8, P = 0.004) and RRV (92% vs. 66%, P = 0.05 and 498.3 vs. 205.6, P = 0.01) at either dose level than did the younger infants. There were no significant differences in seroconversion rates or antibody titers to human rotavirus types G1 to G4 between the two vaccination groups. CONCLUSIONS: RRV-TV at a dose of 4 x 10(6) pfu can be safely administered to infants 6 to 24 weeks of age. A single dose of 4 x 10(6) pfu of RRV-TV was significantly more immunogenic than a single dose of 4 x 10(5) pfu but did not improve responses to the human serotypes. Older vaccine recipients demonstrated significantly higher IgA and neutralizing antibody seroconversion rates and antibody titers than younger infants independent of dosage.


Antibodies, Viral/biosynthesis , Rotavirus Vaccines , Rotavirus/immunology , Vaccines, Attenuated/administration & dosage , Viral Vaccines/administration & dosage , Administration, Oral , Double-Blind Method , Drug Administration Schedule , Humans , Immunoglobulin A/immunology , Infant , Vaccination , Vaccines, Attenuated/immunology , Viral Vaccines/immunology
16.
J Infect Dis ; 173(2): 306-13, 1996 Feb.
Article En | MEDLINE | ID: mdl-8568290

Interference between oral poliovirus vaccine (OPV) and monovalent (RRV-S1) and tetravalent (RRV-TV) rhesus-human rotavirus vaccines was evaluated. Serum antibody responses to OPV and rotavirus vaccines and efficacy of rotavirus vaccines were compared among control and vaccine groups stratified by number of concurrent OPV and rotavirus vaccinations received. Neutralizing antibody titers to poliovirus type 1 tended to rise more steeply in placebo than RRV-TV recipients, but there were no significant differences in seroprevalence or in geometric mean titers (GMTs) of antibodies to types 1, 2, or 3 among groups. Concurrent OPV resulted in lower IgA GMTs to rotavirus in RRV-S1 but not RRV-TV recipients. Rotavirus gastroenteritis rates among rotavirus vaccines did not differ by number of concurrent OPV doses received, but the sample sizes were too small to rule out any effect. These results suggest OPV and rhesus-human rotavirus vaccines may be given at the same visit in the United States.


Antibodies, Viral/biosynthesis , Poliovirus Vaccine, Oral/administration & dosage , Rotavirus Infections/prevention & control , Rotavirus Vaccines , Vaccination , Viral Vaccines/administration & dosage , Administration, Oral , Child, Preschool , Double-Blind Method , Gastroenteritis/immunology , Gastroenteritis/prevention & control , Gastroenteritis/virology , Humans , Infant , Poliomyelitis/immunology , Poliomyelitis/prevention & control , Poliovirus/immunology , Poliovirus Vaccine, Oral/adverse effects , Poliovirus Vaccine, Oral/immunology , Retrospective Studies , Rotavirus/immunology , Rotavirus Infections/immunology , Vaccines, Attenuated/administration & dosage , Vaccines, Combined , Viral Vaccines/adverse effects , Viral Vaccines/immunology
17.
Pediatrics ; 97(1): 7-13, 1996 Jan.
Article En | MEDLINE | ID: mdl-8545227

OBJECTIVE: Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs). DESIGN: In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2, 4, and 6 months of age. Vaccines contained 4 x 10(5) plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus. RESULTS: The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea. CONCLUSION: RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.


Gastroenteritis/prevention & control , Gastroenteritis/virology , Rotavirus Vaccines , Rotavirus/immunology , Viral Vaccines/therapeutic use , Administration, Oral , Double-Blind Method , Humans , Immunization Schedule , Infant , Rotavirus/classification , Serotyping , Severity of Illness Index , Vaccines, Attenuated
18.
Minerva Gastroenterol Dietol ; 41(3): 251-4, 1995 Sep.
Article It | MEDLINE | ID: mdl-8519865

The authors describe the case of the sixty-one-year-old man admitted to hospital because of a growing jaundice that after the surgical operation proved to be caused by a compression of the PBV determined by a voluminous aneurysm of the hepatic artery. The integrity of the gastroduodenal artery made it possible to make a simple aneurysmectomy with clinic. The patient was discharged from hospital after fifteen days from the surgical operation; he was surgically healed and with normal enzymatic values. The follow-up two years after discharge confirmed a hematochemical state within normal limits.


Aneurysm , Hepatic Artery , Aneurysm/complications , Aneurysm/diagnosis , Aneurysm/surgery , Humans , Jaundice/etiology , Male , Middle Aged
19.
Acta Paediatr ; 82(3): 223-7, 1993 Mar.
Article En | MEDLINE | ID: mdl-8388275

Rhesus-human reassortant tetravalent rotavirus vaccine at a titer of 4 x 10(4) plaque forming units was evaluated for immunogenicity in 194 6-8-week-old breast-fed Turkish infants. The vaccine was administered orally as a single dose following either a meal of breast milk or 30 ml of sodium bicarbonate-buffered soy milk formula. Four-fold or greater responses in rotavirus IgA ELISA antibody were detected in 62% and 65% of the infants in the two groups, respectively (p = 0.62). In a smaller comparison group of non-breast-fed infants, an IgA response was detected in 7 of 11 (64%) cases. In all vaccinees, a serological response was detected in 72% of the initially seronegative and 47% of the initially seropositive infants (p = 0.001). We conclude that the take of rhesus-human reassortant tetravalent rotavirus vaccine in breast-fed infants is not compromised by breast feeding before vaccination. However, a higher titered preparation of the same vaccine may be required to improve overall immunogenicity in young infants, particularly in those with pre-vaccination rotavirus antibody.


Breast Feeding , Immunoglobulin A/immunology , Infant Food , Rotavirus/immunology , Vaccination , Viral Vaccines/administration & dosage , Administration, Oral , Humans , Immunoglobulin A/blood , Immunoglobulin A/drug effects , Infant , Vaccines, Attenuated , Viral Vaccines/chemistry
20.
Vaccine ; 11(7): 747-53, 1993.
Article En | MEDLINE | ID: mdl-8393606

To assess safety and immunogenicity, 213 healthy infants aged 6 weeks to 4 months were randomized to receive a single dose of placebo, a 10(4) or 10(5) p.f.u. dose of rhesus rotavirus (RRV) serotype 3, human-RRV reassortant (VP-7 serotypes 1, 2 or 4) or a 10(4) or 10(5) p.f.u. dose of tetravalent rotavirus vaccine (containing equal parts of serotype 1, 2, 3 and 4 strains). The infants were fed ad libitum before and after vaccination; no buffer was used. For 7 days after vaccination, potential vaccine side effects were monitored, and no significant differences were noted for any symptom evaluated among the single serotype, tetravalent or placebo groups. Sera, obtained before and 28 days after vaccination, were measured for antibody to rotavirus by IgG, IgA and IgM enzyme-linked immunosorbent assay in all subjects, and by neutralizing antibody to the individual serotypes by plaque reduction in placebo and tetravalent vaccinees. The serological response rates for serotypes 1, 2, 3, 4 and the tetravalent vaccine were 25, 12, 19, 11 and 22%, respectively, at 10(4) p.f.u.; 47, 50, 35, 29 and 61%, respectively, at 10(5) p.f.u.; and 37% for placebo. The tetravalent vaccine was more immunogenic at 10(5) than at 10(4) p.f.u. (p = 0.04). Grouped together, the vaccines at 10(5) p.f.u. (single serotype and tetravalent) were more immunogenic than the vaccines at 10(4) p.f.u. (38 of 85 versus 17 of 94 seroresponders; p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)


Antibodies, Viral/biosynthesis , Rotavirus Vaccines , Rotavirus/immunology , Viral Vaccines/immunology , Female , Humans , Infant , Male , Vaccines, Attenuated/adverse effects , Vaccines, Attenuated/immunology , Viral Vaccines/adverse effects
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