Factors influencing acceptance of influenza vaccination given in an ED.

Factors correlating with successful administration of flu vaccine in an emergency department (ED) were examined. Patients 18 years and older were screened for indications for flu immunization. Vaccine was offered to those with indications. Of 3425 patients screened, 1311 had indications, 705 of 1311 agreed to immunization, and 513 of 705 were immunized. Factors related to immunization agreement were comorbidity, interviewer, and being 50 to 64 years old with prior immunization. Immunization factors were month, comorbidity, and not being pregnant. Factors associated with suboptimal acceptance and receipt should be addressed in future efforts.

Peripheral blood gene expression profile associated with sustained virologic response after peginterferon plus ribavirin therapy for chronic hepatitis-C genotype 1.

We investigated the relationship between global gene expression in peripheral blood mononuclear cells (PBMCs) during the first 4 weeks of peginterferon alfa and ribavirin therapy and long-term eradication of hepatitis-C genotype 1 infections in 23 patients. A sustained virologic response (SVR), defined as an undetected serum HCV ribonucleic acid (RNA) at week 72, was the virologic response endpoint. PBMC RNA was prepared at week 0 and week 4 from 23 patients (17 black and 6 white Americans), and hybridized to Affymetrix GeneChip HG-U133 plus 2.0 arrays. Compared to week 0, 269 genes were differentially expressed at week 4 of treatment, including many genes regulated by alpha interferons and associated with host immunity (p<0.0001), cell signal transduction (p<0.001) and cellular protein metabolism (p<0.001). Expression of these 269 genes at week 0 and week 4 did not differ significantly between patients with and without a SVR. In contrast, SVR was associated with differential expression of 98 genes at week 4 (false discovery rate <0.01). Many of the genes have been implicated in control of HCV lifecycle and thus may play important roles in HCV clearance during peginterferon and ribavirin therapy.

Improving Predictive Accuracy in Elections.

The problem of accurately predicting vote counts in elections is considered in this article. Typically, small-sample polls are used to estimate or predict election outcomes. In this study, a machine-learning hybrid approach is proposed. This approach utilizes multiple sets of static data sources, such as voter registration data, and dynamic data sources, such as polls and donor data, to develop individualized voter scores for each member of the population. These voter scores are used to estimate expected vote counts under different turnout scenarios. The proposed technique has been tested with data collected during U.S. Senate and Louisiana gubernatorial elections. The predicted results (expected vote counts, predicted several days before the actual election) were accurate within 1%.

Recombivax-HB: perspectives past, present and future.

Hepatitis B disease has caused a heavy burden worldwide. The development of an immunogenic, efficacious and safe vaccine to combat this problem has already eased this burden to some extent. The incorporation of the vaccine into the infant and childhood immunization schedule has led to a decrease in the number of new hepatitis B cases reported each year, and there has been a significant decline in hepatocellular carcinoma in children. This implies that the future will see less hepatitis B disease as the infant and adolescent population that has been immunized ages, meaning that the disease burden should fall even further.

Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age.

BACKGROUND: Herpes zoster (HZ) incidence rises with age, especially after 50 years of age, probably due to waning varicella-zoster virus (VZV)-specific immunity. The Shingles Prevention Study [Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults, N Engl J Med 2005;352:2271-84], enrolled people >/= 60 or years of age and showed that zoster vaccine prevents HZ and postherpetic neuralgia (PHN), presumably through boosting VZV-specific immunity. This study of people >/= 50 or years of age compared the safety and tolerability of two zoster vaccine potencies. METHODS: Adults >/= 50 or years old enrolled in a randomized, double-blind, multicenter study to compare the safety and tolerability of one dose of two zoster vaccine potencies, approximately 58,000 and approximately 207,000 plaque-forming units/dose. Adverse experiences (AEs) were recorded on a standardized Vaccination Report Card for 42 days postvaccination. For assessment of injection-site AEs, clinically acceptable tolerability was predefined based on experience with PNEUMOVAX 23, a licensed vaccine recommended for use in older people. RESULTS: Six hundred and ninety-eight subjects (age 50-90 years, median 64 years) were enrolled. No serious vaccine-related AEs were reported. Similar AE rates were observed in the higher and lower potency groups (overall systemic AEs: 37.5 and 39.3%, vaccine-related systemic AEs: 10.9 and 13.2%, injection-site AEs: 63.0 and 59.8%). Rates for a combined endpoint of moderate or severe injection-site pain/tenderness/soreness and swelling were 17.2% (95% CI 13.9, 21.0) and 9.0% (95% CI 5.6, 13.4), respectively. Most combined endpoint events were reported as moderate in intensity. CONCLUSIONS: Both vaccine potencies were generally well tolerated in this study of people > or years of age. Although rates of some moderate or severe injection-site AEs were greater in the higher potency group, all rates met the prespecified criteria for clinically acceptable tolerability.

A comprehensive patient assessment and physician reminder tool for adult immunization: effect on vaccine administration.

We determined if a patient-self assessment/provider reminder tool (A/R) would increase administration of the eight vaccines that may be indicated for adults. In three family practice clinics, the A/R was completed by intervention patients and given to their provider. Control patients received an exercise reminder. On the day of the intervention, influenza, pneumococcal polysaccharide, and tetanus-diphtheria (Td) vaccines vaccine were administered significantly (P<0.01) more commonly to intervention patients in one clinic, Td in the second, and none in the third. There were no additional significant differences during one year of follow-up. A number of barriers to comprehensive vaccination were encountered.

Determining indications for adult vaccination: patient self-assessment, medical record, or both?

CONTEXT: Eight or more vaccines may be indicated for adults in the United States. Determining if any vaccines are needed requires integrating information on the patient's demographic and behavioral risk factors and health status, the health status of the patient's close contacts, and the patient's immunization history. This process can be time consuming for providers and their staff. We used patient self-assessment as a method of determining which vaccines are indicated for a patient and whether indicated vaccines had been received. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional convenience sample of 300 adults in three family practice settings. Participants completed a self-assessment tool to determine if influenza, pneumococcal, measles, mumps, and rubella (MMR), tetanus, hepatitis A and hepatitis B vaccines were indicated and previously received. A chart audit was then performed to obtain similar information. MAIN OUTCOME MEASURES: Agreement (kappa statistic [< 0.00: poor agreement; 0.00-0.20: slight; 0.21-0.40: fair; 0.41-0.60: moderate; 0.61-0.80: substantial; 0.81-1.00: almost perfect]) between the self-assessment tool and the audit for (1) indicated vaccines and (2) previous receipt of indicated vaccines indicated according to both the assessment form and the audit. RESULTS: Agreement between the self-assessment tool and chart review was substantial or better only for pneumococcal and MMR vaccines (kappa=0.65 and 0.85, respectively). For influenza vaccine, agreement improved (from kappa = 0.56 to kappa = 0.74) when indications attributable to health conditions of family members were excluded. Agreement regarding receipt of vaccines was highest for influenza vaccine (kappa = 0.70). Only 57% of patients correctly recalled tetanus vaccination that were documented in the medical record (kappa = -0.04). Kappa statistics were unreliable for hepatitis A and B vaccines because so few vaccinations had been received. CONCLUSIONS: Discrepancies in agreement regarding indications for vaccines appeared to result from absence of information in the medical record regarding high risk behaviors and family contacts. Lack of agreement regarding vaccines that had been previously been received appeared due to both poor recall and lack of documentation. Combining medical record audit with self-assessment may be the most complete assessment of vaccination status of adults, but requires reconciling disagreements. Electronic medical records and registries that contain information about risk factors and previously administered vaccines may be necessary to overcome some these problems.

Safety and immunogenicity of concomitant versus nonconcomitant administration of hepatitis B, tetanus-diphtheria, and measles-mumps-rubella vaccines in healthy eleven- to twelve-year-olds.

PURPOSE: To study safety and immunogenicity of concomitant administration of hepatitis B (HB), Tetanus-diphtheria (Td), and Measles-mumps-rubella (MMR) vaccines in healthy 11-12-year-olds. METHOD: One hundred ninety-seven healthy 11-12-year-olds from the general community were randomized in an unblinded study to concomitant vaccination with Recombivax HB brand of HB vaccine and Td and MMR vaccines or to HB given at a separate time from Td and MMR vaccination. Primary analyses were for induction of protective immunity and safety. Secondary endpoints were mean geometric antibody titers for HB and a boosting effect for Td and MMR. Differences in immunogenicity were analyzed using the one-sided Pearson's Chi-square test. RESULTS: Concomitant vaccination for HB, Td, and MMR had a significantly increased incidence of headache, red eyes, and rash compared with nonconcomitant vaccination. There was no significant difference in incidence of serious adverse events, rates of protective immunity, or in secondary endpoints. CONCLUSIONS: Concomitant HB, Td, and MMR vaccination in 11-12-year-olds is as safe and immunogenic as nonconcomitant vaccination.

Interferon-stimulated gene expression in black and white hepatitis C patients during peginterferon alfa-2a combination therapy.

BACKGROUND & AIMS: Black American patients are less likely to eradicate hepatitis C virus (HCV) infections during treatment with peginterferon (PEG-IFN) and ribavirin. We hypothesized that racial differences in IFN-stimulated antiviral gene induction during treatment might be responsible. METHODS: We examined myxovirus resistance-A (MxA), RNA-dependent protein kinase (PKR), 2'-5' oligoadenylate synthetase (2,5-OAS), and adenosine deaminase-1 (ADAR1) gene expression in the peripheral blood mononuclear cells (PBMCs) of 31 black and 11 white HCV genotype 1 patients at baseline and at weeks 4-12 during PEG-IFN alfa-2a combination treatment. The primary study end point was the early virologic response (EVR)-either an undetectable serum HCV-RNA level or a > or =2-log decrease in serum HCV-RNA level at week 12 compared with week 0. RESULTS: The EVR rate was 67.7% in blacks and 63.6% in whites. Both blacks and whites experienced a significant (200%-500%) increase in 2,5-OAS, MxA, PKR, and ADAR1 expression at treatment weeks 4-12 compared with baseline (P < .01). However, the relationship between IFN-stimulated gene expression and the EVR differed by race. White responders exhibited higher 2,5-OAS and MxA levels at week 4 than white nonresponders (P < .05). IFN-stimulated gene levels did not correlate with EVR in blacks. Black responders had much lower MxA and PKR levels at week 4 than black nonresponders (P < .05). However, black responders maintained increased 2,5-OAS, MxA, and PKR levels from weeks 4-12, whereas the levels decreased to baseline at weeks 8-12 in black nonresponders. CONCLUSIONS: The mechanisms of resistance to PEG-IFN combination therapy may be different in black and white HCV genotype 1 patients.

Acute hepatitis E infection in a visitor to Louisiana.

A man from Africa had been visiting Mississippi and Louisiana when he had development of acute hepatitis. Although hepatitis E is endemic to many parts of the world and has been associated with large outbreaks, it has remained relatively uncommon in this country. With growing foreign travel and an ever-increasing number of cases reported nationally, hepatitis E infection should be considered more frequently in the differential diagnosis of acute hepatitis.

Evaluation of The Federal Bureau of Prisons protocol for selection of which hepatitis C-infected inmates are considered for treatment.

The Federal Bureau of Prisons limits hepatitis C therapy to those inmates with certain biochemical abnormalities. To evaluate this protocol, an analysis was done on data collected on hepatitis C infected inmates in the Louisiana Department of Corrections. A quality assurance database of hepatitis C infected inmates evaluated in the Louisiana Department of Corrections was reviewed for liver biopsy and laboratory results. Patients were compared as to whether they would have been biopsied under the Federal Bureau of Prisons protocol and if there were histologic differences between those who would and those who would not have been biopsied. Of 490 inmates biopsied, 26% (129) had an alanine aminotransferase level between one and two times the upper limit of normal without other biochemical abnormalities. If treating stages 2-4, 48% of these would qualify for treatment (15% if treating stages 3-4). There was no statistical difference between this group and either the group with an alanine aminotransferase level between one and two times the upper limit of normal and with other laboratory abnormalities or the group with an alanine aminotransferase level greater than or equal to two times the upper limit of normal and without other abnormalities. In the Louisiana Department of Corrections, the Federal Bureau of Prisons protocol was neither sensitive nor specific enough at identifying those that should be considered for hepatitis C therapy.

Peginterferon alfa-2a (40 kd) and ribavirin for black American patients with chronic HCV genotype 1.

Black Americans (blacks) have a high prevalence of chronic hepatitis C virus (HCV) infection and respond poorly to therapy with interferon alfa-based regimens, but they have been underrepresented in clinical trials. The aim of this study was to assess the rate of sustained virological response (SVR) to peginterferon alfa-2a (40 kd) in combination with ribavirin in black patients chronically infected with HCV genotype 1. In a prospective, multicenter, open-label trial, 78 black and 28 white American interferon-naïve patients were enrolled to receive once weekly subcutaneous injections of 180 microg peginterferon alfa-2a plus oral ribavirin (1000 mg/d for patients weighing less than 75 kg and 1200 mg/d for patients weighing 75 kg or more) for 48 weeks. Pre- and post-treatment liver biopsies were evaluated for necroinflammation and fibrosis. SVR, defined as undetectable (<50 IU/mL) HCV RNA, was 26% in the black group and 39% in the white group. Although the SVR rate was lower in blacks than in whites, the SVR of 26% represents an improvement over previously reported SVR rates from smaller, retrospective studies of black patients. We also observed improvement in fibrosis in 25% of the black patients. No unexpected adverse events occurred. In conclusion, this prospective study evaluating responses of black patients with chronic hepatitis C to peginterferon alfa-2a/ribavirin has demonstrated that treatment can be safely offered to such individuals with reasonable antiviral and histological benefit.