HighlightsPentavalent reassortant rotavirus vaccine was tested for efficacy in infants.The vaccine (BRV-PV) showed excellent tolerability and a good safety profile.Primary analysis efficacy was 36% against SRVGE and up to 60.5% against VSRVGE.The efficacy through 2 years of age was 39.5% (SRVGE) and 54.7% (VSRVGE).The intent to treat analyses confirmed all the per protocol analyses.
The present approach improved mothers' knowledge regarding newborn danger signs and improved their health care seeking behavior for newborn danger signs at community level. Due to lack of faith in government health services, women preferred to seek care from private providers.
Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic populations. Using a combination, such as albendazole (ALB) to diethylcarbamazine (DEC) gives both macrofilaricidal and anti-helmintic activity. However, the safety of the combination versus DEC alone should be established in field studies in large populations prior to incorporation into national programmes. The present study compared the safety, tolerability, and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in populations living in two filariasis endemic villages in the district of Wardha in western India. The study was double blind, parallel group, and randomized. Safety and tolerability study were studied in males and females older than 5 years. Safety was assessed by monitoring if adverse events (AEs) over 5 days affected daily acivities. Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe. Efficacy was evaluated by microfilaraemia (Mf), immunochromatographic test (ICT) and ultrasonography (USG) at 0, 3, 6, and 12 months of follow up. The efficacy study enrolled 103 male patients (aged 18-50 years) in microfilariae positive, clinical disease and asymptomatic, amicrofilaremic groups. There was no significant difference in efficacy between groups at 12 months. Within the Mf positive group, significant differences were seen in microfilaraemia (P < 0.001) with both treatments, and in USG (P < 0.001 and P < 0.004 respectively), at 12 months. The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes. Both drugs were adequately absorbed. The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up. While the safety of the combination has been ascertained, the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up.
ObjectivesTo assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants.DesignRandomised, double-blind, placebo-controlled trial.SettingCommunity setting in rural India.ParticipantsLBW infants aged 3–7 days.InterventionsInfants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months.Main outcome measurePossible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians.Results668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063).ConclusionsDaily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants.Trial registration numberThe study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).
Global health education (GHE) continues to be a growing initiative in many medical schools across the world. This focus is no longer limited to participants from high-income countries and has expanded to institutions and students from low- and middle-income settings. With this shift has come a need to develop meaningful curricula through engagement between educators and learners who represent the sending institutions and the diverse settings in which GHE takes place. The Bellagio Global Health Education Initiative (BGHEI) was founded to create a space for such debate and discussion and to generate guidelines towards a universal curriculum for global health. In this article, we describe the development and process of our work and outline six overarching principles that ought to be considered when adopting an inclusive approach to GHE curriculum development.
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