Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassortant rotavirus vaccine in a new stabilizer/buffer liquid formulation

BACKGROUND: A refrigerator-stable rotavirus (RV) vaccine that withstands gastric acid is anticipated to permit more widespread use of RV vaccine. OBJECTIVE: We investigated for the first time in infants an oral, liquid formulation of G1 and G2 human bovine reassortant rotavirus vaccine (HRRV) with a new stabilizer/buffer (S/B) containing sucrose, sodium phosphate and sodium citrate. METHODS: During 1997 through 1998, 731 healthy infants approximately 2 to 4 months of age were enrolled at 19 US sites to receive 3 HRRV or placebo doses approximately 6 to 8 weeks apart in a partially double blinded study. Infants were randomized to: (1) HRRV with no S/B but with prefeeding; (2) HRRV plus 1 of 3 different concentrations/volumes of S/B; or (3) placebo. RESULTS: No serious vaccine-related adverse experiences or intussusception cases were reported. No statistically significant differences were observed between vaccine and placebo recipients for fever (> or =38.1 degrees C) 0 to 7 days after any dose, irritability, vomiting or diarrhea incidence 0 to 42 days after any dose. Vaccine virus shedding among vaccine recipients was uncommon. Among S/B vaccine groups, proportions of infants with a > or =3-fold titer rise from baseline to Postdose 3 for G1 serum-neutralizing antibody (SNA), G2 SNA, WC3 SNA, serum anti-RV IgA, serum anti-RV IgG and stool anti-RV IgA were generally similar to those of the prefed non-S/B group. CONCLUSIONS: HRRV with a new S/B was generally well-tolerated; immunogenicity was generally similar to the prefed non-S/B group. No intussusception cases were reported, but the small sample size precluded a definitive conclusion. A large international clinical study is under way to address safety and efficacy of an S/B formulation of a pentavalent version of HRRV.     

Comparative analysis of mononuclear cell surface markers in atopic processes--a preliminary study

Atopic disorders are driven by the Th2 cell subset. We have determined the expression of costimulatory molecules and cell surface markers on peripheral CD4+ T cells and antigen presenting cells, in different atopic diseases, and we have also tried to correlate the expression of these markers with the severity of the disease. Cells from patients with atopic and contact dermatitis, mild or severe asthma, and symptomatic and non-symptomatic atopic rhinitis were analyzed by flow cytometry. Our results showed that CD30, CD124, and CD152 expression on CD4+ T cells was significantly higher in atopic dermatitis than in contact dermatitis patients (p < 0.05). It was interesting to observe that the cell surface expression of CD80 in T and B cells from atopic dermatitis patients was not enhanced as opposed to the other atopic diseases we analyzed. Our results suggest that there are differences in the immune mechanisms involved in the different atopic diseases, and that expression of CD30 in CD4+ T cells might be a marker of disease activity in atopic dermatitis.     

The cost-effectiveness of interleukin-1 genetic testing for periodontal disease

BACKGROUND: A genetic test for a composite interleukin-1 (IL-1) genotype is being marketed to predict risk for progression of periodontal disease. The objective of this study was to determine the clinical scenario required to produce cost-effective results with the use of IL-1 testing to identify high-risk patients. METHODS: A disease simulation model was developed using decision-analytic techniques and a 30-year time frame. RESULTS: Using different modeling scenarios, the genetic test produced results ranging from cost savings of $830,140 and 52.8 fewer cases of severe periodontitis to increased costs of $300,430 and 3.6 additional cases of severe periodontitis (per 1,000 patients). Three parameters in the analysis were highly influential: 1) the compliance rate for maintenance therapy in test positive versus non-tested patients; 2) the effectiveness of non-surgical therapy; and 3) the relative risk of disease progression for test positive patients. CONCLUSION: The model produced a wide range of outcomes reflecting our incomplete understanding of the biology, optimal treatment, and genetic susceptibility of periodontal diseases. However, the model demonstrates that three clinical parameters are highly influential in determining if IL-1 testing can be implemented in a primary care setting in a cost-effective manner.     

Disparity in total hip replacement affecting Hispanic Medicare beneficiaries

OBJECTIVE: To compare the utilization of total hip replacement (THR) between Hispanic persons and non-Hispanic persons in a sample with health insurance. RESEARCH DESIGN: Case-control study using Medicare claims data. PATIENTS: The cases were Medicare beneficiaries from Arizona, Illinois, New Mexico, or Texas who underwent a primary THR. The controls were Medicare beneficiaries who did not receive a THR, matched by age, sex, and county of residence. MEASURES: Beneficiary surnames and the race indicator in Medicare records were used to classify beneficiaries' probability of being Hispanic. Conditional logistic regression was used to estimate the odds of receiving of THR, adjusting for Medicaid eligibility. RESULTS: Six thousand four hundred thirty-seven recipients of a primary THR were matched to 12,874 controls. According to the Medicare race indicator, 1% of recipients of THR and 3.3% of controls were Hispanic (P < or =0.001). The odds of THR decreased as the probability of Hispanic ethnicity increased, from an odds ratio (OR) of 1.00 among beneficiaries with non-Hispanic surnames, to an OR of 0.36 among those with heavily Hispanic surnames (95% CI, 0.31, 0.43). Poverty, as reflected by eligibility for Medicaid, did not modify the low odds of THR among Hispanic persons (OR, 0.25 among Medicaid-eligible Hispanic persons; 95% CI, 0.19, 0.33; and OR, 0.30 among Hispanic persons not Medicaid eligible; 95% CI, 0.24, 0.38). CONCLUSION: Hispanic persons with Medicare receive THR at lower rates than do non-Hispanic persons. Because Medicare covers THR, our findings suggest that under utilization of THR by Hispanic persons cannot be attributed to lack of health insurance alone.