Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 46
Filter
1.
Methods Inf Med ; 43(2): 163-70, 2004.
Article in English | MEDLINE | ID: mdl-15136866

ABSTRACT

OBJECTIVE: To assess the quality of automated diagnoses extracted from medical care databases by the Vaccine Safety Datalink (VSD) study. METHODS: Two methods are used to assess quality of VSD diagnosis data. The first method compares common automated and abstracted diagnostic categories ("outcomes") in 1-2% simple random samples of study populations. The second method estimates positive predictive values of automated diagnosis codes used to identify potential cases of rare conditions (e.g., acute ataxia) for inclusion in nested case-control medical record abstraction studies. RESULTS: There was good agreement (64-68%) between automated and abstracted outcomes in the 1-2% simple random samples at 3 of the 4 VSD sites and poor agreement (44%) at 1 site. Overall at 3 sites, 56% of children with automated cerebella ataxia codes (ICD-9 = 334) and 22% with "lack of coordination" codes (ICD-9 = 781.3) met objective clinical criteria for acute ataxia. CONCLUSIONS: The misclassification error rates for automated screening outcomes substantially reduce the power of screening analyses and limit usefulness of screening analyses to moderate to strong vaccine-outcome associations. Medical record verification of outcomes is needed for definitive assessments.


Subject(s)
Database Management Systems/standards , Health Maintenance Organizations , Quality Control , Safety , Vaccines/adverse effects , Child, Preschool , Health Services Research , Humans , International Classification of Diseases , United States
2.
Pediatrics ; 108(6): E112, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11731639

ABSTRACT

OBJECTIVES: To evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenzae type b, and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk. METHODS: We conducted a case-control study within 4 health maintenance organizations (HMOs) that participate in the Vaccine Safety Datalink project of the Centers for Disease Control and Prevention. Study eligibility was restricted to children who met the following criteria: 1) born during 1988 through 1997; 2) HMO member since birth; 3) continuously enrolled for first 6 months of life; and 4) at least 12 months of HMO membership before diabetes incidence date (or index date for controls) unless incidence date was before 12 months of age. All 4 HMOs maintain registries of their members who have diabetes, and we used the registries to identify potential cases of diabetes. We conducted chart reviews to verify that potential cases met the World Health Organization epidemiologic case definition for type 1 diabetes mellitus (ie, a physician's diagnosis of diabetes plus treatment with daily insulin injections). We defined the incidence date of diabetes as the first date that the child received a diagnosis of diabetes. We attempted to match 3 controls to each case. Controls had the same eligibility criteria as cases and were matched to individual cases on HMO, sex, date of birth (within 7 days), and length of health plan enrollment (up to the incidence or index date). The index date for controls was defined as the incidence date of the case to which the control was matched. Chart abstraction was performed by trained chart abstractors using standardized forms. In addition to complete vaccination histories, the chart abstraction forms for both cases and controls included information on sociodemographic characteristics, selected medical conditions, history of breastfeeding, and family medical history. We used conditional logistic regression to estimate the odds ratio (OR) of diabetes associated with vaccination, with vaccine exposure defined as before the diabetes incidence date (or index date for controls). RESULTS: Two hundred fifty-two confirmed cases of diabetes and 768 matched controls met the study eligibility criteria. The OR (95% confidence interval) for the association with type 1 diabetes was 0.28 (0.07-1.06) for whole cell pertussis vaccine (predominantly in combination as diphtheria, tetanus toxoids and pertussis vaccine), 1.36 (0.70-2.63) for measles-mumps-rubella, 1.14 (0.51-2.57) for Haemophilus influenzae type b, 0.81 (0.52-1.27) for hepatitis B vaccine, 1.16 (0.72-1.89) for varicella vaccine, and 0.92 (0.53-1.57) for acellular pertussis-containing vaccines. Compared with children who had not received hepatitis B vaccine, the OR of diabetes was 0.51 (0.23-1.15) for children vaccinated at birth and 0.86 (0.54-1.35) for those first vaccinated against hepatitis B at 2 months of age or later. Race and ethnicity and family history of diabetes were independently associated with risk of type 1 diabetes, but adjustment for these factors did not materially alter the ORs for any of the vaccines. CONCLUSIONS: In this large, population-based, case-control study, we did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines. Our study adds to previous research by providing data on newer vaccines, including hepatitis B, acellular pertussis, and varicella vaccines. For the older vaccines, our results are generally in agreement with previous studies in not finding any increased risks. Ours is the first epidemiologic study to evaluate the possibility that timing of vaccination is related to risk of clinical diabetes in children. Our results on hepatitis B vaccine do not support the hypothesis; risk of type 1 diabetes was not different between infants vaccinated at birth and those who received their first vaccination later in life. The results of our study and the preponderance of epidemiologic evidence do not support an association between any of the recommended childhood vaccines and an increased risk of type 1 diabetes. Suggestions that diabetes risk in humans may be altered by changes in the timing of vaccinations also are unfounded.


Subject(s)
Diabetes Mellitus, Type 1/epidemiology , Immunization Schedule , Vaccination/statistics & numerical data , Adolescent , Bacterial Capsules , Case-Control Studies , Child , Child, Preschool , Haemophilus Vaccines/administration & dosage , Hepatitis B Vaccines/administration & dosage , Humans , Infant , Logistic Models , Polysaccharides, Bacterial/administration & dosage , Risk , Vaccination/adverse effects
3.
N Engl J Med ; 345(9): 656-61, 2001 Aug 30.
Article in English | MEDLINE | ID: mdl-11547719

ABSTRACT

BACKGROUND: The administration of the diphtheria and tetanus toxoids and whole-cell pertussis (DTP) vaccine and measles, mumps, and rubella (MMR) vaccine has been associated with adverse neurologic events, including seizures. We studied the relation between these vaccinations and the risk of a first seizure, subsequent seizures, and neurodevelopmental disability in children. METHODS: This cohort study was conducted at four large health maintenance organizations and included reviews of the medical records of children with seizures. We calculated the relative risks of febrile and nonfebrile seizures among 679,942 children after 340,386 vaccinations with DTP vaccine, 137,457 vaccinations with MMR vaccine, or no recent vaccination. Children who had febrile seizures after vaccination were followed to identify the risk of subsequent seizures and other neurologic disabilities. RESULTS: Receipt of DTP vaccine was associated with an increased risk of febrile seizures only on the day of vaccination (adjusted relative risk, 5.70; 95 percent confidence interval, 1.98 to 16.42). Receipt of MMR vaccine was associated with an increased risk of febrile seizures 8 to 14 days after vaccination (relative risk, 2.83; 95 percent confidence interval, 1.44 to 5.55). Neither vaccination was associated with an increased risk of nonfebrile seizures. Analyses of automated data alone gave results similar to the analyses of the data from medical-record reviews. The number of febrile seizures attributable to the administration of DTP and MMR vaccines was estimated to be 6 to 9 and 25 to 34 per 100,000 children, respectively. As compared with other children with febrile seizures that were not associated with vaccination, the children who had febrile seizures after vaccination were not found to be at higher risk for subsequent seizures or neurodevelopmental disabilities. CONCLUSIONS: There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.


Subject(s)
Measles-Mumps-Rubella Vaccine/adverse effects , Pertussis Vaccine/adverse effects , Seizures, Febrile/etiology , Child , Child, Preschool , Cohort Studies , Humans , Infant , Infant, Newborn , Proportional Hazards Models , Recurrence , Risk , Seizures/etiology
4.
Bull World Health Organ ; 78(2): 186-94, 2000.
Article in English | MEDLINE | ID: mdl-10743283

ABSTRACT

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field.


Subject(s)
Database Management Systems , Health Maintenance Organizations , Immunization Programs , Vaccines/standards , Centers for Disease Control and Prevention, U.S. , Health Policy , United States , Vaccines/adverse effects
6.
Am J Epidemiol ; 149(2): 186-94, 1999 Jan 15.
Article in English | MEDLINE | ID: mdl-9921964

ABSTRACT

The availability of large, population-based, automated, medical care databases provides unique opportunities for monitoring the safety of childhood vaccines. The authors assessed the quality of automated vaccination databases by comparing them with vaccinations documented in paper-based medical records at three large US West Coast health maintenance organizations (HMOs) participating in the Vaccine Safety DataLink (VSD) study, a Centers for Disease Control and Prevention collaborative study of childhood vaccine safety. The authors randomly selected 1% or 2% samples of VSD study populations (n = 1,224-2,577) for data quality analyses. Agreement between automated and abstracted vaccinations required identical triads of child identification number, vaccination date, and vaccine type. Separate analyses were conducted for each HMO and for each vaccine type administered between 1991 and 1995. Agreement was measured by three matching proportions: 1) the proportion of automated vaccinations present in the abstracted source, 2) the proportion of abstracted vaccinations present in the automated source, and 3) the proportion of vaccinations from either source present in both sources. Overall, for common childhood vaccines, proportion 1 ranged from 83% to 99%, proportion 2 ranged from 82% to 98%, and proportion 3 ranged from 70% to 97%. Lack of automated data was the most frequent type of discrepancy, followed by date mismatches and vaccine type mismatches. Vaccination exposure classification errors in the range reported here were found by mathematical modeling to only modestly bias measured medical outcome rate ratios toward the null hypothesis. The results of the data quality analyses support the usefulness of vaccination exposure data derived from these automated HMO vaccination databases.


Subject(s)
Adverse Drug Reaction Reporting Systems/standards , Child Health Services/standards , Databases, Factual/standards , Health Maintenance Organizations/standards , Medical Records/standards , Safety , Vaccination/adverse effects , Vaccination/standards , Abstracting and Indexing/standards , Bias , Centers for Disease Control and Prevention, U.S. , Humans , Infant , United States
7.
Pediatr Infect Dis J ; 17(7): 605-11, 1998 Jul.
Article in English | MEDLINE | ID: mdl-9686726

ABSTRACT

BACKGROUND: We used information from the Vaccine Safety Datalink (VSD) about approximately 1 million children enrolled in four health maintenance organizations to assess the morbidity from diarrhea and estimate the disease burden of rotavirus. METHODS: We examined trends of diarrhea-associated hospitalizations and emergency room (ER) visits among VSD children ages 1 month through 4 years during October, 1992, through September, 1994 (two rotavirus seasons) and estimated the morbidity from rotavirus on the basis of characteristic patterns of age and seasonality. RESULTS: Overall diarrhea was associated with 6.3% of hospitalizations and 4% of ER visits. During a child's first 5 years of life, we estimated that 1 in 57 was hospitalized and 1 in 21 required an ER visit because of diarrhea. Each year the number of diarrhea-associated hospitalizations and ER visits was greatest in winter among children ages 4 to 23 months and peaked in November in California and during February in Oregon and Washington. The winter seasonality of diarrhea-associated hospitalizations reflected the trends for diarrhea of presumed noninfectious and viral etiologies, which together accounted for most (92.9%) hospitalizations. CONCLUSIONS: Diarrhea is an important cause of morbidity among VSD children. The epidemiologic patterns of diarrhea-associated hospitalizations and ER visits resembled those reported previously for rotavirus diarrhea, suggesting that rotavirus may be a major contributor to the overall morbidity from diarrhea. Enhanced surveillance by screening for rotavirus in a sample of children with diarrhea will permit a more accurate assessment of the disease burden of this pathogen and the cost effectiveness of a rotavirus immunization program.


Subject(s)
Diarrhea, Infantile/epidemiology , Diarrhea, Infantile/virology , Rotavirus Infections/epidemiology , California/epidemiology , Child, Preschool , Data Collection , Health Maintenance Organizations , Hospitalization/statistics & numerical data , Humans , Infant , Infant, Newborn , Oregon/epidemiology , Retrospective Studies , Seasons , Washington/epidemiology
8.
Diabetes Care ; 21(1): 80-6, 1998 Jan.
Article in English | MEDLINE | ID: mdl-9538974

ABSTRACT

OBJECTIVE: To describe features of pediatric-onset type 2 diabetes in the Hispanic population. RESEARCH DESIGN AND METHODS: The medical records of 55 Hispanic subjects with diabetes who were treated from 1990 to 1994 in a pediatric clinic serving lower income Mexican-Americans were reviewed to assess the frequency and clinical features of type 2 diabetes. Additionally, nondiabetic siblings of several patients underwent oral glucose tolerance testing, and a survey of six high schools in the same county was performed. RESULTS: Seventeen of 55 (31%) of the diabetic children and adolescents had type 2 diabetes. An additional 4 Hispanic children with type 2 diabetes treated in other clinics were also identified, yielding a total of 21 subjects who were used to describe the characteristics of childhood type 2 diabetes. At presentation, all were obese (mean BMI 32.9 +/- 6.2 kg/m2), 62% had no ketonuria, and fasting C-peptide levels were elevated (4.28 +/- 3.43 ng/ml). Diabetes was easily controlled with diet, sulfonylureas, or low-dose insulin. No autoantibodies were present in those tested, and family histories were positive for type 2 diabetes. Compliance was poor, and 3 subjects developed diabetic complications. Of the tested siblings, 2 of 8 had impaired glucose tolerance and 5 of 8 had stimulated hyperinsulinemia, correlated with BMI (r = 0.80, P < 0.05). The school survey identified 28 diabetic adolescents, 75% more than expected (P < 0.01). The Hispanic enrollment at each school was highly correlated with the number of diabetic students (r = 0.87, P = 0.011). CONCLUSIONS: Genetic susceptibility to type 2 diabetes, when coupled with obesity, can produce type 2 diabetes in Mexican-American children. This diagnosis should be considered in young Hispanic patients, who might otherwise be assumed to have type 1 diabetes, and also when caring for overweight Hispanic youth with a family history of type 2 diabetes, in whom intervention may prevent or delay diabetes onset.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/physiopathology , Hypoglycemic Agents/therapeutic use , Mexican Americans , Adolescent , Age Factors , Bicarbonates/blood , Blood Glucose/analysis , Body Mass Index , C-Peptide/blood , California , Child , Diabetes Mellitus, Type 2/genetics , Female , Follow-Up Studies , Glucose Tolerance Test , Glycated Hemoglobin/analysis , Humans , Insulin/blood , Male , Nuclear Family , Pedigree
9.
Pediatrics ; 99(6): 765-73, 1997 Jun.
Article in English | MEDLINE | ID: mdl-9164767

ABSTRACT

OBJECTIVE: To fill the large "gaps and limitations" in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine. METHODS: Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety. RESULTS: Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310 618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR, 3.0; 95% CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95% CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95% CI, 0.7 to 1.4). CONCLUSION: Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent infrastructure for safety and other studies of vaccines.


Subject(s)
Adverse Drug Reaction Reporting Systems , Program Development , Vaccines/adverse effects , Bacterial Proteins/adverse effects , Child , Child, Preschool , Data Collection , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Haemophilus Vaccines/adverse effects , Health Maintenance Organizations , Humans , Infant , Information Systems , Measles Vaccine/adverse effects , Measles-Mumps-Rubella Vaccine , Mumps Vaccine/adverse effects , Quality Control , Risk , Rubella Vaccine/adverse effects , Seizures/chemically induced , United States , Vaccines, Combined/adverse effects
10.
Pediatr Infect Dis J ; 16(5): 500-3, 1997 May.
Article in English | MEDLINE | ID: mdl-9154545

ABSTRACT

OBJECTIVE: To assess the level of increased risk, if any, of hospitalizations for aseptic meningitis after Jeryl-Lynn mumps strain measles-mumps-rubella (MMR) vaccine in the Vaccine Safety Datalink population. STUDY DESIGN: A possible increased risk of aseptic meningitis 8 to 14 days after receipt of MMR was observed in a preliminary screening analysis of automated data from the Vaccine Safety Datalink (VSD) project Year 2 analysis. To further evaluate this association a retrospective 10-year matched case-control study was undertaken in the four health maintenance organizations (HMOs) in the VSD project. Cases ascertained from a broad scan of the automated data were validated against a standard case definition. Two controls matched on age, sex, HMO and HMO membership were assigned per case. RESULTS: The VSD project involves the cooperative collection of automated vaccination and medical outcome data from four large HMOs that currently have 500,000 children younger than 7 years of age under surveillance. Review of automated screening results from the first 2 years of data revealed a possible increased risk of aseptic meningitis 0 to 14 days after MMR with a relative risk of 3.61 (95% confidence interval, 1.0 to 13.1) although the total number of cases was small. Although the automated data had suggested a possible association of aseptic meningitis with MMR containing the Jeryl-Lynn strain of mumps, review of validated hospitalized cases during the observation period did not reveal evidence of an increased risk of aseptic meningitis after MMR containing the Jeryl-Lynn strain of mumps (odds ratio < 1.0 for all analyses). CONCLUSION: Although it is recognized that hospitalized cases represent a minority of the total cases of aseptic meningitis, it is reassuring that in this evaluation no increased risk of aseptic meningitis after MMR vaccine was found.


Subject(s)
Hospitalization/statistics & numerical data , Measles Vaccine/adverse effects , Meningitis, Aseptic/epidemiology , Meningitis, Aseptic/etiology , Mumps Vaccine/adverse effects , Rubella Vaccine/adverse effects , Case-Control Studies , Child, Preschool , Confidence Intervals , Female , Health Maintenance Organizations , Humans , Incidence , Infant , Male , Measles-Mumps-Rubella Vaccine , Registries , Retrospective Studies , Risk Factors , Statistics as Topic , United States/epidemiology , Vaccines, Combined/adverse effects
11.
HMO Pract ; 11(1): 13-7, 1997 Mar.
Article in English | MEDLINE | ID: mdl-10165549

ABSTRACT

Recognizing the potential of large databases within HMOs for the evaluation of vaccine safety, the Centers for Disease Control and Prevention (CDC) funded the Vaccine Safety Datalink project, linking outcome and vaccine exposure information at Group Health Cooperative of Puget Sound, Kaiser Permanente Northwest, Kaiser Permanente Medical Care Program Northern California, and Southern California Kaiser Permanente. Integral to the Vaccine Safety Datalink Project was the development of Immunization Tracking Systems at each site; this report describes the effort required to establish these tracking systems. Essential requirements are the methods used to insure data quality and to educate system users. Tracking systems can be a valuable means for assessing vaccine coverage, evaluating barriers to complete immunization, and studying the effectiveness of interventions design to improve immunization coverage. Finally, we report on recent efforts to link HMO Immunization Tracking Systems with developing regional tracking systems.


Subject(s)
Database Management Systems , Health Maintenance Organizations/organization & administration , Immunization Programs/organization & administration , Registries , California , Centers for Disease Control and Prevention, U.S. , Child, Preschool , Humans , Immunization Programs/standards , Immunization Programs/statistics & numerical data , Medical Records Systems, Computerized , Private Sector , Public Sector , Quality Control , United States , Washington
12.
J Infect Dis ; 174(4): 752-9, 1996 Oct.
Article in English | MEDLINE | ID: mdl-8843213

ABSTRACT

Population-based prospective surveillance of invasive pneumococcal disease was done in Southern California from 31 March 1992 to 1 April 1995; 814 cases were identified, for an incidence of 12.5/100,000 persons/year. The incidence among persons < or = 2, < or = 5, and > or = 65 years of age was 145, 72, and 32/100,000, respectively. More than 95% of cases included bacteremia; incidence of meningitis was 0.8/100,000. Among children < or = 2 years of age, 79% of isolates were obtained in the outpatient setting, compared with 16% of isolates among persons > or = 15 years of age. Eighty percent of isolates were serotypes included in heptavalent pneumococcal conjugate vaccines currently being evaluated. Children < or = 2 years of age were at highest risk of having an isolate resistant to penicillin. Among resistant isolates, high-level resistance increased from 4% to 21% over a 3-year period. Prospective epidemiologic data are needed to perform a protective efficacy trail of pneumococcal conjugate vaccines in infants, among whom most invasive pneumococcal disease is vaccine-preventable.


Subject(s)
Bacterial Vaccines/immunology , Pneumococcal Infections/prevention & control , Streptococcus pneumoniae/immunology , Adolescent , Adult , Aged , California/epidemiology , Child , Child, Preschool , Humans , Incidence , Infant , Middle Aged , Penicillin Resistance , Pneumococcal Infections/epidemiology , Prospective Studies , Research Design , Streptococcus pneumoniae/drug effects , Vaccines, Conjugate/immunology
13.
Pediatr Infect Dis J ; 15(7): 590-6, 1996 Jul.
Article in English | MEDLINE | ID: mdl-8823852

ABSTRACT

OBJECTIVES: To evaluate the relative safety and immunogenicity of the two recombinant hepatitis B vaccines licensed in the United States with doses recommended for routine immunization of low risk infants and a schedule that corresponds with routine pediatric visits. METHODS: Healthy infants were immunized at 2, 4 and 6 months of age with hepatitis B vaccine manufactured by either SmithKline Beecham (Engerix-B, 10 micrograms/dose, n = 228) or Merck and Co. (Recombivax HB, 2.5 micrograms/dose, n = 200). Adverse reactions were ascertained by parental reports and interviews and by review of medical records. Antibody concentrations to hepatitis B surface antigen (anti-HBs) were measured in sequential serum specimens by enzyme immunoassay. RESULTS: Adverse reactions were mild and the rates were not significantly different between the two groups. After the first and second doses the rates of seropositivity (> or = 10 mIU/ml) and seroprotection (> or = 10 mIU/ml) were significantly higher in infants given SmithKline Beecham vaccine (P < 0.01). After the second and third doses infants given SmithKline Beecham vaccine also had significantly higher geometric mean anti-HBs concentrations compared with those given Merck vaccine (348.0 mIU/ml vs. 66.9 and 1914.8 mIU/ml vs. 514.8 mIU/ml, respectively, P < 0.001). Nevertheless after the third dose 99% of infants in both vaccine groups achieved seroprotective antibody concentrations. CONCLUSIONS: Both recombinant hepatitis B vaccines were safe and immunogenic when administered concurrently with other pediatric vaccines at 2, 4 and 6 months of age, but earlier protective responses were observed with the SmithKline Beecham vaccine than with the Merck vaccine.


Subject(s)
Hepatitis B Vaccines/administration & dosage , Hepatitis B , Vaccines, Synthetic/administration & dosage , Consumer Product Safety , Female , Hepatitis B/immunology , Hepatitis B/prevention & control , Hepatitis B Antibodies/analysis , Hepatitis B Vaccines/adverse effects , Humans , Immunization Schedule , Infant , Male , Vaccines, Synthetic/adverse effects
14.
Vaccine ; 14(8): 811-6, 1996 Jun.
Article in English | MEDLINE | ID: mdl-8817829

ABSTRACT

A recombinant hepatitis B vaccine was administered to over 5000 infants in a prospective, randomized and blinded study. Infants were given either recombinant hepatitis B vaccine (Engerix-B, SmithKline Beecham Pharmaceuticals, 10 micrograms dose-1) or a Haemophilus influenzae type b (Hib) conjugate vaccine at 2, 4 and 6 months of age simultaneously with diphtheria-tetanus-pertussis and oral polio vaccines. Adverse reactions were ascertained by parental reports and interviews, and review of medical records. Blood specimens collected from 269 infants given hepatitis B vaccine were assayed for antibody to hepatitis B surface antigen (anti-HBs) by enzyme immunoassay. Infants given hepatitis B vaccine experienced low rates of adverse reactions that were similar or lower than the rates in infants given Hib conjugate vaccine. The geometric mean anti-HBs concentrations were 9.6 mIU ml-1 after one dose, 333 mIU ml-1 after two doses and 1812 mIU ml-1 after three doses (99% had levels > or = 10 mIU ml-1). Antibody responses to diphtheria and tetanus toxoids were unaffected by simultaneous administration of hepatitis B or Hib conjugate vaccine. Engerix-B vaccine was safe and immunogenic when given with other routine childhood immunizations at 2, 4 and 6 months of age, and should provide long-term protection against hepatitis B virus infection.


Subject(s)
Hepatitis B Vaccines/administration & dosage , Vaccines, Synthetic/administration & dosage , Antibodies, Bacterial/biosynthesis , Bacterial Vaccines/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Hepatitis B Antibodies/biosynthesis , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Humans , Infant , Poliovirus Vaccine, Inactivated/administration & dosage , Prospective Studies , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/immunology
15.
Hum Hered ; 45(3): 150-6, 1995.
Article in English | MEDLINE | ID: mdl-7615300

ABSTRACT

The gene frequencies of nine different genetic polymorphic markers [ABO, MNS and P blood groups; haptoglobin, transferrin, Gc protein, complement (C3), properdin factor B and alpha 1-antitrypsin] were determined in 94 Mexican-Americans residing in the Los Angeles, California area. Comparisons with published data on Mexican-Americans living in other areas of the United States or in Mexico itself revealed no significant differences in the gene frequencies between this and previous studies. However, data from the current study demonstrated significant differences in ABO and haptoglobin allele frequencies compared to published non-Hispanic Caucasian data. These data suggest a large degree of genetic homogeneity in the Mexican-American population residing in the United States. Additional gene marker studies will be important to test this hypothesis and further define the degree of non-Hispanic Caucasian admixture in this population.


Subject(s)
ABO Blood-Group System/genetics , Gene Frequency , Haptoglobins/genetics , Mexican Americans/genetics , White People/genetics , Blood Group Antigens/genetics , Blood Proteins/genetics , Case-Control Studies , Diabetes Mellitus, Type 1/ethnology , Genetic Markers , Humans , Los Angeles
16.
J Clin Lab Immunol ; 46(4): 143-54, 1995.
Article in English | MEDLINE | ID: mdl-8733027

ABSTRACT

Patients with inflammatory bowel disease (IBD) are known to have increased antibodies to several food and bacterial antigens. To assess selected isotype contributions in greater detail, we examined the concentrations of IgA, IgG, IgE, and IgG4 antibodies to five selected antigens, two of bacterial and three of food origin. Thirty patients with IBD and thirty matched healthy controls were studied. Most antibodies were increased in IBD patients compared to controls. Statistically significant increases were more frequent in Crohn's disease (CD) than in ulcerative colitis (UC). An unexpected finding was that IBD patients treated with sulfasalazine had statistically higher levels of most IgA antibodies than healthy controls, while steroid treated patients had lower levels. These findings suggest differing effects on the immune systems of IBD patients by each of these commonly used drugs.


Subject(s)
Antigens, Bacterial/immunology , Food/adverse effects , Immunoglobulins/analysis , Inflammatory Bowel Diseases/immunology , Adult , Aged , Animals , Caseins/immunology , Colitis, Ulcerative/immunology , Crohn Disease/immunology , Gliadin/immunology , Haemophilus influenzae/immunology , Humans , Immunoglobulins/drug effects , Inflammatory Bowel Diseases/drug therapy , Middle Aged , Multivariate Analysis , Radioimmunoassay , Serum Albumin, Bovine/immunology , Steroids/therapeutic use , Sulfasalazine/therapeutic use , Tetanus Toxoid/immunology
17.
J Infect Dis ; 170(3): 717-20, 1994 Sep.
Article in English | MEDLINE | ID: mdl-8077736

ABSTRACT

Coded serum samples collected from healthy obstetric patients at delivery were examined by ELISA for IgG antibody to the purified type III polysaccharide of group B streptococci. When 217 patients were divided into 4 groups according to age (group I =16-20 years, n = 56; group II = 21-25, n = 53; group III = 26-30, n = 54; group IV = 31-35, n = 54), antibody concentrations were significantly lower in group I than in older patients. Fewer subjects in group I had measurable antibody levels (> or = 0.05 microgram/mL) than in groups II-IV (41% vs. 76%, P < .001). The geometric mean in group I (0.09 microgram/mL) was significantly lower (P < .001) than in the older groups (0.23, 0.19, and 0.20 microgram/mL, respectively) with little or no overlap of the 95% confidence limits (1.96 SE) about the means. These findings may be relevant to the observation of a significantly greater risk of both early- and late-onset group B streptococcal disease in infants of teenage mothers.


Subject(s)
Antibodies, Bacterial/blood , Immunoglobulin G/blood , Maternal Age , Pregnancy/immunology , Streptococcus agalactiae/immunology , Adolescent , Adult , Analysis of Variance , Female , Humans , Labor, Obstetric , Polysaccharides, Bacterial/immunology , Pregnancy/blood , Pregnancy, High-Risk
18.
J Infect Dis ; 170(1): 76-81, 1994 Jul.
Article in English | MEDLINE | ID: mdl-8014524

ABSTRACT

In a prospective, randomized, double-blind efficacy trial, the immunogenicity of 10 lots of Haemophilus influenzae type b capsular polysaccharide-tetanus toxoid conjugate vaccine (PRP-T) was evaluated. More than 10,000 infants received PRP-T or hepatitis B vaccine at about 2, 4, and 6 months of age along with other childhood vaccines. In a subset of infants, geometric mean concentrations of total anticapsular antibody were 0.08, 0.79, and 5.29 micrograms/mL after the first, second, and third doses, respectively. Four lots of reconstituted lyophilized PRP-T vaccine were significantly more immunogenic than 6 lots of aqueous vaccine (P = .03). In a stepwise regression model, the most important additional factors affecting anticapsular antibody concentrations were the time between the third dose and the blood draw, race, and breast-feeding status at 6 months of age. Immune responses to diphtheria and tetanus toxoids were not significantly different for infants given PRP-T or hepatitis B vaccines along with diphtheria-tetanus toxoid-pertussis vaccine.


Subject(s)
Haemophilus Vaccines/immunology , Haemophilus influenzae/immunology , Tetanus Toxoid/immunology , Antibodies, Viral/immunology , Double-Blind Method , Female , Gestational Age , Haemophilus Vaccines/administration & dosage , Humans , Infant , Infant, Newborn , Male , Prospective Studies , Tetanus Toxoid/administration & dosage , Vaccines, Conjugate/immunology
19.
Am J Public Health ; 84(7): 1154-7, 1994 Jul.
Article in English | MEDLINE | ID: mdl-8017544

ABSTRACT

Haemophilus influenzae type b (Hib) vaccination coverage and disease incidence were measured among preschool-aged children residing in inner-city Los Angeles. Among children 1.5 to 14 months of age, vaccination coverage of at least one dose increased from 0% in 1990 to 82% (95% confidence interval [CI] = 73%, 91%) in 1992. Among children 15 to 59 months old, vaccination coverage of at least one Hib dose administered at or after age 15 months increased from 35% (95% CI = 29%, 41%) in 1990 to 63% (95% CI = 56%, 70%) in 1992. Although Hib vaccination has reduced disease incidence in this population, greater use of vaccine can result in further reductions.


Subject(s)
Haemophilus Infections/epidemiology , Haemophilus Vaccines/therapeutic use , Urban Health/statistics & numerical data , Child, Preschool , Haemophilus Infections/prevention & control , Humans , Incidence , Infant , Los Angeles/epidemiology , Poverty Areas
20.
Am J Med Genet ; 51(3): 234-9, 1994 Jul 01.
Article in English | MEDLINE | ID: mdl-8074151

ABSTRACT

The prevalence of various chronic diseases was compared in 517 individuals with alopecia areata, and 2,969 of their first degree relatives. As previous reports have suggested an increased incidence of diabetes in relatives of patients with alopecia areata, special attention was given to the prevalence of Type 1 and Type 2 diabetes in the patients and in their relatives. Several immunologic diseases were increased in alopecia probands and relatives. Thyroid disease, vitiligo, Addison disease, and pernicious anemia were more prevalent in probands and in their relatives than in the general population. Specifically, a high rate of thyroid disease was found in probands (14.7%) and in their first degree relatives (4.2%). Only one proband had Type 1 diabetes, yet there were 14 sibs with Type 1 diabetes. Thus, Type 1 diabetes was significantly more prevalent in the sibs (1.2%) than in either the probands with alopecia (0.2%), or the general population (0.12-0.25%) (P < 0.05)). In contrast, Type 2 diabetes was not more common in probands or in sibs than in the general population. These data suggest that alopecia areata protects against Type 1 diabetes in predisposed individuals. The high rate of thyroid disease suggests that screening probands and first degree relatives for thyroid disease should be considered.


Subject(s)
Alopecia Areata/genetics , Alopecia Areata/immunology , Diabetes Mellitus, Type 1/epidemiology , Diabetes Mellitus, Type 1/genetics , Addison Disease/complications , Addison Disease/epidemiology , Addison Disease/genetics , Adolescent , Adult , Aged , Alopecia Areata/complications , Alopecia Areata/epidemiology , Anemia, Pernicious/complications , Anemia, Pernicious/epidemiology , Anemia, Pernicious/genetics , Autoimmune Diseases/epidemiology , Autoimmune Diseases/genetics , Chi-Square Distribution , Child , Child, Preschool , Diabetes Mellitus, Type 1/complications , Disease Susceptibility/immunology , Family Health , Female , Humans , Infant , Male , Middle Aged , Prevalence , Risk Factors , Sex Factors , Surveys and Questionnaires , Thyroiditis, Autoimmune/complications , Thyroiditis, Autoimmune/epidemiology , Thyroiditis, Autoimmune/genetics , United States/epidemiology , Vitiligo/complications , Vitiligo/epidemiology , Vitiligo/genetics
SELECTION OF CITATIONS
SEARCH DETAIL
...