A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal.

Typhoid remains one of the major serious health concerns for children in developing countries. With extremely drug-resistant cases emerging, preventative measures like sanitation and vaccination, including typhoid conjugate vaccines (TCV) remain the mainstay in its prevention and control. Different types of TCVs are being developed to meet the global demand. This report outlines the results from a study done to assess the immunogenicity and safety of Vi-Diphtheria toxoid (Vi-DT) TCV in Nepal. The study was a randomized, active-controlled, immunological non-inferiority and safety study. Eligible participants from Sunsari and Morang districts of eastern Nepal were randomized into 4 study groups (A-D) within 3 age strata (6 months to <2 years, 2 to <18 years, and 18 to 45 years). Groups A to C received a single dose (25 µg) of Vi-DT test vaccine from any of the 3 lots, while group D received the comparator, Typbar-TCV®, Vi-tetanus toxoid (Vi-TT) vaccine (25 µg) in 1:1:1:1 ratio and evaluated at 4 weeks postvaccination with 6 months follow-up. Amongst 400 randomized participants, anti-Vi-IgG seroconversion rates for all age strata in Vi-DT pooled groups (A+B+C) were 100.00% (97.5% CI 98.34-100.00) vs 98.99% (97.5% CI 93.99-99.85) in Vi-TT group (D) at 4 weeks. Comparable safety events were reported between the groups. Three serious adverse events (1 in Vi-DT; 2 in Vi-TT group) were reported during the 6 months follow-up, none being related to the investigational product. Thus, Vi-DT vaccine is safe, immunogenic, and immunologically non-inferior to Vi-TT when analyzed at 4 weeks postvaccination.

Evaluation of the Outcomes of Proximal Femoral Nail Antirotation II in the Treatment of Trochanteric Fracture in Elderly Patients.

Background Intertrochanteric fractures are common injuries among the elderly population and those with osteoporosis. The study was conducted in order to evaluate the outcome of Proximal Femoral Nail Antirotation II (PFN-A2) in the treatment of these fractures in elderly patients. Methods Twenty-five elderly patients (range 60 to 73 years) with trochanteric fractures who were treated with PFN-A2 at Government Medical College Amritsar were included in this prospective observational study. These patients were followed up regularly until six months post-operatively. The functional and radiological evaluations were done at six, 12, 16, and 20 weeks. The functional outcome was evaluated using the Harris Hip Score (HHS). Results The mean age incidence for trochanteric fractures was 64 years. There were no cases of intra-operative and postoperative femoral fractures. The mean operating time was 85.6 minutes. Radiological union was seen in all of the 25 patients. The mean time for fracture union time in our study was 13.8 weeks. The average Harris Hip Score in our study was calculated at three months as 74.3 and at six months as 85.08. The p-value was highly significant (0.001) for this improved outcome. This study found PFN-A2 related secondary varus deformities in 8.0% of the patients (two patients). Only one patient (4%) developed surgical site infection (SSI). Conclusion PFN-A2 provides adequate functional results in terms of fixation and healing. This can be further enhanced by good pre-operative planning, correct technique of entry point, and meticulous placement of implant with a helical blade in both anteroposterior (AP), lateral view, and distal locking and non-acceptance of reduction in varus. A good reduction is required to achieve a good functional outcome. We conclude that the PFN-A2 has the benefit of closed reduction, short operative time, preservation of biology, less soft tissue damage, and early rehab.