Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers.

Typhoid fever is a significant public health concern with most of the sufferers between 15 and 25 y of age in Nepal. We undertook this study to demonstrate Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT) conjugate vaccine which is non-inferior to Typbar typhoid conjugate vaccine, a Vi polysaccharide vaccine conjugated with tetanus toxoid (Vi-TT) with a focus on the adult population from Dhulikhel Hospital which was one of the total four sites in Nepal. In this study, we assigned the eligible participants in 1:1:1:1 ratio by block randomization, and stratified into three age groups (6 months to less than 2 y, 2 y to less than 18 y, and 18 y to 45 y), allotted to Group A, B, C, and D. Group A, B, and C received 25 µg (0.5 mL) of Vi-DT study vaccine and participants in Group D received 25 µg (0.5 mL) Vi-TT vaccine. We descriptively analyzed safety in all the participants receiving one dose of the investigational vaccine. The anti-Vi-IgG seroconversion rate in Vi-DT recipients was 99.71% (97.5% CI 98.04-99.96; 344 of 345 participants) and 99.13% (94.27-99.87; 114 of 115) in Vi-TT recipients which indicates that Vi-DT vaccine is non-inferior to Vi-TT vaccine. In safety aspect, 16.81% of total subject had at least one solicited adverse reaction and 22.61% of the Vi-TT participants experienced at least one solicited adverse reaction with most of them being local adverse reactions. None of the enrolled participants reported serious adverse events. Our study shows that a single dose of the Vi-DT vaccine is immunogenic, safe to administer and non-inferior to the Vi-TT vaccine four weeks after vaccination.

Clinical Profile, Radiological Findings, and Risk Factors Associated with Pneumonia among Children Admitted in Dhulikhel Hospital.

BACKGROUND: Pneumonia is the commonest lung disease which is a major cause of mortality and morbidity in young children and is a common acute respiratory infection. The presentation varies among the cases. The study was done to know the risk factors, clinical profile, radiological findings, and short-term outcome of the admitted patients with pneumonia between six months to sixteen years at Dhulikhel Hospital. METHODS: A hospital based observational prospective cross-sectional study done in 65 cases over the period of 17 months in children admitted with pneumonia at Pediatrics department of Dhulikhel Hospital. Socio-demographic variables, clinical profile, radiological profile, diagnosis, and short-term outcome were collected and analyzed using descriptive statistics. RESULTS: Out of 65 patients, 76.9% cases were children between six months to five years. The most common clinical presentation was fever (98.5%) followed by cough (86.2%). Crepitation (78.5%) and subcostal retraction (29.2%) were common clinical findings. Disseminated intravascular coagulation, thrombocytopenia, sepsis, and right heart failure were associated with mortality. The requirement of mechanical ventilation, oxygenation, and inotrope support was more likely to have fatal outcome. CONCLUSIONS: Fever and cough were the most common clinical presentation and right middle zone consolidation was the most common finding in children admitted with pneumonia.