ABSTRACT
OBJECTIVE: This study aims to evaluate the safety and immunogenicity of the SKYVaricella vaccine in healthy Vietnamese children aged 12 months to 12 years. METHODS: This open-label, single-arm study involved 201 children divided into two groups: 60 children aged 12 months to 5 years and 141 children aged 6 to 12 years. Safety was assessed through immediate reactions, solicited adverse events within 7 days, and unsolicited events up to Day 42. Immunogenicity was evaluated by seroconversion rates (SCR) and geometric mean titer (GMT) increments using fluorescent antibody-to-membrane antigen (FAMA) on the day of vaccination (D0) and 42 days after vaccination (D42). RESULTS: All participants completed the follow-up. Immediate adverse events included pain (8.0%), redness (8.0%), and swelling (20.9%) at the injection site. Within 7 days, pain (17.9%) and swelling (12.4%) were mild and self-resolving. Unsolicited adverse events were infrequent and mild. Both age groups achieved 100% SCR. GMT of varicella-zoster virus antibodies increased from 1.37 (SD 1.97) at D0 to 18.02 (SD 2.22) at D42, a 13.12-fold rise. No Grade 3 adverse events were observed. CONCLUSION: The SKYVaricella vaccine shows a robust immunogenic response and favorable safety profile in Vietnamese children aged 12 months to 12 years. These findings endorse its potential inclusion in pediatric vaccination programs as a reliable preventive option against varicella.
Subject(s)
Antibodies, Viral , Chickenpox Vaccine , Vaccines, Attenuated , Humans , Male , Female , Vietnam , Child , Chickenpox Vaccine/immunology , Chickenpox Vaccine/adverse effects , Chickenpox Vaccine/administration & dosage , Antibodies, Viral/blood , Antibodies, Viral/immunology , Infant , Vaccines, Attenuated/immunology , Vaccines, Attenuated/adverse effects , Vaccines, Attenuated/administration & dosage , Child, Preschool , Vaccination , Chickenpox/prevention & control , Chickenpox/immunology , Immunogenicity, Vaccine , Herpesvirus 3, Human/immunology , Southeast Asian PeopleABSTRACT
BACKGROUND: After coronary artery bypass graft (CABG) surgery, heart failure is still major problem. The valuable marker for it is needed. AIM: Evaluating the role of serial NT-proBNP level in prognosis and follow-up treatment of acute heart failure after CABG surgery. METHODS: The prospective, analytic study evaluated 107 patients undergoing CABG surgery at Ho Chi Minh Heart Institute from October 2012 to June 2014. Collecting data was done at pre- and post-operative days with measuring NT-proBNP levels on the day before operation, 2 hours after surgery, every next 24 h until the 5th day, and in case of acute heart failure occurred after surgery. RESULTS: On the first postoperative day (POD1), the NT-proBNP level demonstrated significant value for AHF with the cut-off point = 817.8 pg/mL and AUC = 0.806. On the second and third postoperative day, the AUC value of NT- was 0.753 and 0.751. It was statistically significant in acute heart failure group almost at POD 1 and POD 2 when analyzed by the doses of dobutamine, noradrenaline, and adrenaline (both low doses and normal doses). CONCLUSION: Serial measurement of NT-proBNP level provides useful prognostic and follow-up treatment information in acute heart failure after CABG surgery.
