Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia.

BACKGROUND: This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia. METHODS: In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally > or =28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo. RESULTS: Mean age at enrollment was 23.5 +/- 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8-80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9-77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1-92.4%) and any (64.2%; 95% CI: 44.2-77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients. CONCLUSIONS: CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia.

Nocardia pneumonia with empyema thoracis in a healthy neonate: a case report.

A 40-day-old male infant presented with fever and non-productive cough for 3 weeks, tachypnea and dyspnea 5 days before admission. The chest radiograph and computed tomographic (CT) scan revealed right lung consolidation with pleural effusion. Pleural tapping showed frank pus that grew Nocardia asteroides. The CT scan of the brain and abdomen were normal. The patient was treated with 15 mg/kg/day of trimethoprim and 75 mg/kg/day of sulfamethoxazole intravenously for 3 weeks and then orally for 6 months with complete recovery. T cell quantitative studies were normal and anti-HIV was non-reactive. A flow cytometric assay with Staphylococcal aureus and phorbol myristate acetate (PMA) as the stimulants showed normal oxidative burst which represented normal intracellular killing. One year after completion of treatment, he was healthy and the chest radiograph was normal.

Protective efficacy of hepatitis B vaccine without HBIG in infants of HBeAg-positive carrier mothers in Thailand.

The primary objective of this study was to estimate the efficacy of a recombinant hepatitis B vaccine (H-B-VAXII) in preventing chronic hepatitis B infection when given alone without concomitant hepatitis B immune globulin (HBIG) to healthy Thai infants born of HBeAg-positive carrier mothers. The infants received a 0.5 ml (5 micro g HBsAg) intramuscular injection of H-B-VAXII either at birth, 1, and 6 months of age (Schedule A) or at birth, 1, 2, and 12 months of age (Schedule B). Blood drawings for the determination of hepatitis B virus (HBV) serologic markers were scheduled 4, 9, and 13 months following the initial dose of vaccine. At 13 months, 5 (10%) of 50 infants vaccinated on Schedule A and 7 (14.9%) of 47 infants vaccinated on Schedule B had experienced chronic HBV infection. Based on an expected infection rate in unimmunized infants of either 70 or 90%, the overall efficacy for both schedules combined was estimated to be 82.3% (95% CI: 70.6, 90.6) or 86.2% (95% CI: 77.1, 92.7), respectively. Corresponding schedule-specific estimates were for Schedule A: 85.7% (95% CI: 68.8, 95.3) or 88.9% (95% CI: 75.8, 96.3) and for Schedule B: 78.7% (95% CI: 59.6, 91.1) or 83.4% (95% CI: 68.6, 93.1). These results suggest that in areas of high endemicity, where mothers may not always be screened for HBV infection, routine vaccination of infants at birth with a course of hepatitis B vaccine alone should be highly protective, even for very high-risk infants of HBeAg-positive mothers.

Immunogenicity and safety of two doses of a paediatric hepatitis A vaccine in thai children: comparison of three vaccination schedules.

As fewer children in Thailand are exposed to hepatitis A virus (HAV) and so do not have seroprotective anti-HAV antibodies, they are becoming an important source of HAV transmission. A flexible HAV vaccination schedule would facilitate incorporation of the vaccine into existing immunization programmes, and we compared the immunogenicity and safety of three HAV immunization schedules. An open, randomized, clinical trial was carried out in which healthy children were given a primary dose of the inactivated hepatitis A vaccine, Avaxim 80 paediatric, with a booster dose 6, 12 or 18 months later. Anti-HAV geometric mean concentrations (GMC), seroconversion rates, and GMC ratios (GMCR) of the three schedules were compared and reactogenicity was evaluated. Seroconversion rates were above 98 per cent (per group) up to the booster. The three schedules were equivalent in terms of GMCRs, each eliciting a large booster effect. Local reactions were reported for fewer than 9 per cent of each group after dose one and less frequently after the booster dose. Injection site pain, gastrointestinal tract disorders and fever were the most commonly reported adverse events. No vaccine-related serious adverse events were reported. It was concluded that the hepatitis A vaccine, Avaxim 80 paediatric, is safe and immunogenic when given as a two-dose schedule to healthy seronegative children aged 5-10 years, with the second dose given at either 6, 12 or 18 months after the first.