Burden of childhood rotavirus disease on health systems in the United States.

BACKGROUND: To determine the burden of rotavirus disease before the introduction of rotavirus vaccines. METHODS: From February 2005 to June 2006, prospective rotavirus surveillance was conducted in Cincinnati, Ohio, and Durham, North Carolina. Children < 5 years of age presenting at hospitals and outpatient clinics with acute gastroenteritis (AGE) of < 72 hours duration were enrolled. Stool samples were first tested for rotavirus by EIA and the VP7 type was determined by RT-polymerase chain reaction for rotavirus-positive samples. Medical costs were obtained from billing or accounting data. RESULTS: A total of 1998 children were enrolled, with a mean age of 16.9 months. Among 1601 (80%) patients with a stool specimen, 44% were rotavirus positive. The rotavirus detection rate was 38% for patients admitted to hospital, 60% for patients requiring a short-stay hospital visit (< 24 hour hospitalization), 49% for emergency department visits, and 37% for outpatient visits. During the rotavirus season, rotavirus accounted for 56% of all AGE cases. Only 11% of rotavirus-positive children were assigned the rotavirus-specific ICD-9-CM code and this proportion varied considerably by clinical setting. The VP7 genotypes identified were G1, 79%; G2, 14%; G3, 5%; G9, 1%; and G12, 1%. For children hospitalized with rotavirus, the estimated median direct cost was $4565, the average length of stay was 1.9 days, and parents lost 3.4 days of work. For short-stay, emergency department, and outpatient visits, the estimated median costs were $3160, $867, and $75, respectively. CONCLUSIONS: Before the widespread use of rotavirus vaccines in the United States, rotavirus was prevalent among children treated in hospital-based and outpatient settings and was associated with a substantial proportion of pediatric medical visits for AGE.

Effectiveness of a bivalent Haemophilus influenzae type B-hepatitis B vaccine in preventing hepatitis B virus infection among children born to hepatitis B e antigen-positive carrier mothers.

BACKGROUND: This observational study evaluated a modified immunoprophylactic regimen (hepatitis B immune globulin [HBIG]) and a dose of thimerosal-free monovalent hepatitis B (HB) vaccine shortly after birth followed by doses of thimerosal-free bivalent Haemophilus influenzae type b (Hib)-HB vaccine at 2 and 4 months of age, and a booster at 12 months of age) in infants at high risk of hepatitis B virus (HBV) infection (mothers HBeAg+). METHODS: Children >or=6 months of age vaccinated in routine clinical practice were tested twice (>or=6 months apart) for HBV antigens surface antigen (HBsAg) and "e" antigen, and for antibody to HBsAg. Partial nucleotide sequence analysis was performed on HBV DNA isolated from infants identified with a breakthrough chronic HBV infection. A fully sequential statistical design was used to maximize patient safety and study efficiency. RESULTS: Four of 60 children developed chronic HBV infection despite vaccination, but at no point did the cumulative number of cases reach the boundary of statistical significance. Overall, the analysis adjusted for sequential testing yielded an estimated breakthrough rate of 6.7% (90% CI: 2.3%-14.6%). In a subset of uninfected children tested for antibody to HBsAg 1 to 4 months after the second dose of Hib-HB vaccine, 90% (9/10) had >or=10 milli-International Units per milliliter (mIU/mL). The third dose of Hib-HB vaccine induced a secondary increase in the level of antibody; 94.7% (18/19) of a second group developed >or=100 mIU/mL, with a geometric mean concentration of 771 mIU/mL (95% CI: 351.4-1692.1 mIU/mL). CONCLUSION: The tested regimen is comparably effective to historical experience with a standard one employing HBIG plus monovalent thimerosal-containing HB vaccine given at 0, 1, and 6 months of age.