Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life

Rotavirus gastroenteritis is one of the leading causes of diarrhea in Indian children less than 2 years of age. The 116E rotavirus strain was developed as part of the Indo-US Vaccine Action Program and has undergone efficacy trials. This paper reports the efficacy and additional safety data in children up to 2 years of age. In a double-blind placebo controlled multicenter trial, 6799 infants aged 6-7 weeks were randomized to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. The primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. We randomly assigned 4532 and 2267 subjects to receive vaccine and placebo, respectively, with over 96% subjects receiving all three doses of the vaccine or placebo. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. The overall incidence of severe RVGE per 100 person years was 1.3 in the vaccine group and 2.9 in the placebo recipients. Vaccine efficacy against severe rotavirus gastroenteritis in children up to 2 years of age was 55.1% (95% CI 39.9 to 66.4; p<0.0001); vaccine efficacy in the second year of life of 48.9% (95% CI 17.4 to 68.4; p=0.0056) was only marginally less than in the first year of life [56.3% (95% CI 36.7 to 69.9; p<0.0001)]. The number of infants needed to be immunized to prevent one episode of severe RVGE in the first 2 years of life was 40 (95% CI 28.0 to 63.0) and for RVGE of any severity, it was 21 (95% CI 16.0 to 32.0). Serious adverse events were observed at the same rates in the two groups. None of the eight intussusception events occurred within 30 days of a vaccine dose and all were reported only after the third dose. The sustained efficacy of the 116E in the second year of life is reassuring

Economic burden of acute lower respiratory tract infection in South African children.

BACKGROUND: Acute lower respiratory tract infections (ALRTI) are a leading cause of childhood mortality, but there are few data on disease costs in developing countries. OBJECTIVES: This study's purpose was to analyse ALRTI's costs-of-illness and economic burden in urban South African children. METHODS: ALRTI costs-of-illness (expressed in US$2010) at a tertiary hospital were measured using a micro-costing approach nested within a clinical trial. Demographic, epidemiological and data on use of health resources were integrated with costs-of-illness to estimate the economic burden of ALRTI in urban South African children aged <5 years. RESULTS: 745 children experiencing 858 ALRTI episodes were studied. 338 (39.4$266 (95% CI 245-286) and 1287 (95% CI 1174-1401) in HIV-infected patients, and US$257 (95$5968 (95% CI 4025-8056) in HIV-uninfected patients and US$7849 in one HIV-infected patient. Under-5 children experienced an estimated 424,220 episodes annually of ALRTI. ALRTI treatment cost the public health system an estimated US$28,975,000 while an additional US$539,000 of costs were borne by families. CONCLUSION: ALRTIs in children <5 years impose a heavy economic burden on families and the South African public health-care system