Safety and Immunogenicity of the Live Attenuated Varicella Vaccine in Vietnamese Children Aged 12 Months to 12 Years: An Open-Label, Single-Arm Bridging Study.

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.

Gallbladder volvulus in a 5-years old Vietnamese female: A case report.

Gallbladder volvulus (GV) is a medical emergency and a rare cause of acute abdominal pain among the pediatric population. GV is more prominent usually in boys in pediatric patients. If it is not diagnosed and surgically intervened promptly, GV will become a life-threating condition. Fortunately, a safe and effective laparoscopic cholecystectomy is now widely indicated. A 5 years old female patient with abdominal pain and heavy much vomiting was referred to the emergency room in our hospital. She was suspiciously diagnosed with acute inflammation of the gallbladder according to the results of abdominal ultrasound and computerized tomography (CT) scan already performed on admission. One day after the hospitalization, abdominal ultrasound, and CT scan were performed again because of intensification of her abdominal pain and revealed the clinical portrait of GV such as a "floating gallbladder" sign, an echogenic cone structure, an elongated axis displaced horizontally instead of vertically and a lack of intramural blood flow. The acute GV diagnosis was made and the patient was operated, using the laparoscopic cholecystectomy on time, the gallbladder was tightly twisted clockwise at approximately 720°. The operation and postoperative treatment went quite well and the patient was discharged from the hospital on postoperative Day 7. GV is very rare in children, easily omitted or misdiagnosed with cholecystitis. Imaging diagnosis such as ultrasound, CT with contrast helps make diagnosis promptly that avoids severe complications such as gallbladder perforation, necrosis, and biliary peritonitis.

Evaluating the Combination of Human Chorionic Gonadotropin and Clomiphene Citrate in Treatment of Male Hypogonadotropic Hypogonadism: A Prospective Study.

BACKGROUND: In this study, we evaluated MHH patients who wished to preserve fertility, assessing the efficacy of a short course (12 months) of a combined hCG +clomiphene citrate. MATERIALS AND METHODS: The cross-sectional study included 19 patients with hypogonadotropic hypogonadism who were admitted to the Andrology and Fertility Hospital of Hanoi between March 2016 and March 2018. Using hCG every three days in combination with clomiphene citrate 25mg per day until normal testosterone levels are reached, maintain the dose until spermatozoa are present. RESULTS: The mean age was 30.2 ± 5.6. Differences in penis length between the time before and after treatment were significant (p=0.005). The average dose of hCG using in our study was 5579 ± 1773.7 IU. After treatment 6 months and 12 months, the changes in clinical features in all patients and the total hypogonadotropic hypogonadism group were statistically significant (p<0.001). In particular, the differences in testosterone hormone levels in the partial hypogonadotropic hypogonadism group were also statistically significant (p=0.03). No adverse event was observed in our study. The number of patients appearing sperm in the semen is 9 patients (47.4%) after 12 months, but most of the sperm were completely deformed (<1%), and the average motility in the progressive motility group was below 8%. CONCLUSION: In conclusion, a combination of hCG and clomiphene citrate may be an option for MHH patients who desired fertility. After 12 months, 47.4% of patients have sperm in semen but almost all of them were deformity. Hormone profile and secondary sexual characteristics improved significantly. There was no adverse event in our study that considered it as safe therapy.

Plombage for Hemoptysis Control in Pulmonary Aspergilloma: Safety and Effectiveness of Forgettable Surgery in High-Risk Patients.

OBJECTIVES: To evaluate plombage surgery for hemoptysis control in pulmonary aspergilloma in high-risk patients. METHODS: This study was carried out on 75 pulmonary aspergilloma patients presenting with hemoptysis that underwent a plombage surgery for approximately 7 years (November 2011-September 2018) at Pham Ngoc Thach Hospital. They revisited the hospital 6 months after plombage surgery and considered plombage removal. The group whose plombage was removed was compared with that whose plombage was retained 6 and 24 months after surgery. RESULTS: Hemoptysis reduced significantly after surgery. Hemoptysis ceased in 91.67% of the patients and diminished in 8.33% of the patients 6 months after surgery. Similarly, hemoptysis ceased in 87.32% of the patients and diminished in 12.68% of the patients 24 months after surgery. Body mass index (BMI) index, Karnofsky score, and forced expiratory volume in one second (FEV1) increased. Plombage surgery was performed with operative time of 129.5 ± 36.6 min, blood loss during operation of 250.7 ± 163.1 mL, and the number of table tennis balls of 4.22 ± 2.02. No deaths related to plombage surgery were recorded. Plombage was removed in 29 cases because of patients' requirements (89.8%), infection (6.8%), and pain (3.4%). There were no patient developing complications after the treatment and there were no statistically significant differences between the two groups. CONCLUSIONS: Plombage surgery is safe and effective for hemoptysis control in pulmonary aspergilloma. To minimize the risk of long-term complications, surgeons should remove the plombage 6 months after the initial operation.

Immunogenicity, safety and reactogenicity of ROTAVAC® in healthy infants aged 6-8 weeks in Vietnam.

BACKGROUND: ROTAVAC® is derived from human 116E rotavirus (RV) neonatal strain. In this study, we evaluated the immunogenicity, safety and reactogenicity of ROTAVAC® in Vietnam. METHOD: We conducted a phase IV clinical trial in healthy infants aged 6-8 weeks using the complete regimen of ROTAVAC® with three doses. Serum anti-RV IgA was measured by enzyme-linked immunosorbent assay to assess the geometric mean concentration in infants who received the complete regimen of the vaccine. RESULTS: A total of 360 participants were enrolled in this clinical trial. The mean age ± standard deviation at enrollment was 6.9 ± 0.6 weeks. The anti-RV IgA titer was 4.01 ± 3.74 mg/ml pre-vaccination and substantially increased to 29.27 ± 80.64 mg/ml post-vaccination. The value of logIgA significantly increased (p = 0.003) from 0.28 ± 0.79 to 1.03 ± 0.54. The proportion of participants with equal to and greater than 3-fold and 4-fold shifts in pre- to post-vaccination antibody titer (IgA) were 55.4% and 48.3%, respectively. No adverse events or serious adverse events were recorded immediately within 30 min after the administration of each dose. The most common adverse events within 14 days after each visit were fever, unusual crying and irritability. Other adverse events occurred at a low rate, and no case of intussusception was noted. CONCLUSIONS: The complete regimen of ROTAVAC® demonstrated an immunological response with clinically acceptable safety profile. Post-completion of this study, ROTAVAC® is now a WHO-prequalified vaccine and available in Vietnam.

Hemoptysis from complex pulmonary aspergilloma treated by cavernostomy and thoracoplasty.

BACKGROUND: In high-risk patients with complex pulmonary aspergilloma but unable for lung resection, cavernostomy and thoracoplasty could be performed. This study aimed to evaluate this surgery compared two compressing materials. METHODS: A total of 63 in high-risk patients who suffered from hemoptysis due to complex pulmonary aspergilloma and underwent cavernostomy and thoracoplasty surgery from November 2011 to September 2018 at Pham Ngoc Thach hospital were evaluated prospectively studied. Patients were allocated to two groups: the table tennis ball group and tissue expander group. We evaluated at the time of before operation, 6 months and 24 months after operation. RESULTS: Tuberculosis was the most common comorbidity diseases in both groups. Upper lobe occupied almost in location. Hemoptysis symptoms plunged from time to time. Statistically significant Karnofsky score was observed in both groups. Postoperative pulmonary functions (FVC and FEV1) have remained in both groups at all time points. The remarkable results were no deaths related to surgery and low complications both short and long-term. There was no statistical significance between two groups in operative time, blood loss during operation, ICU length-stay time. Four patients died because of co-morbidity in 24 months follow-up. CONCLUSION: Cavernostomy and thoracoplasty was safe and effective surgery for the treatment of complex pulmonary aspergilloma with hemoptysis in high-risk patients. No mortality related to surgery and low complications were recorded. The was no inferiority when compared two compressing materials .

Antiretroviral drug resistance mutations among patients failing first-line treatment in Hanoi, Vietnam.

Objectives: To study the prevalence of drug resistance and genotype testing for HIV drug resistance on HIV/AIDS patients with first-line antiretroviral treatment failure at Dong Da Hospital, Hanoi, Vietnam. Patients and methods: Forty-seven patients in Dong Da Hospital, Hanoi, with confirmation of first-line antiretroviral therapy (ART) failure were enrolled in this study from June 2006 to December 2016. Both the protease and reverse transcriptase genes were amplified and sequenced using Trugene® HIV-1 Genotyping Kit and OpenGene® DNA system at the biomolecular laboratory of the National Institute of Hygiene and Epidemiology, Vietnam. The Stanford HIV database algorithm was used for interpretation of resistance data and genotyping. Results: Drug resistance mutations were 90.7% in patients with first-line treatment failure. Amongst patients with drug resistance mutation, 97.7% resisted to non-nucleoside reverse transcriptase inhibitors (NNRTIs), followed by nucleoside reverse transcriptase inhibitors (NRTIs, 95.3%) and protease inhibitors (PIs, 11.6%). Amongst the genetic mutations resistant to NNRTIs, G190S mutation was the highest (51.2%), K101HQ mutation was 39.5% and Y181I mutation was 34.9%. In genetic mutations to NRTIs, M184V mutation was 88.4%. In thymidine analogue mutations, K70R mutation was the most common (37.2%), followed by D67N, T215F and T69N mutations (27.9%, 27.9% and 25.6%, respectively). In genetic mutations in PIs, M36I and K20R mutations made up 9.3%. In NNRTIs, the prevalence of nevirapine resistance was 55.8%, and that of efavirenz resistance was 4.7%. In NRTIs, the ratio of lamivudine resistance was 93.0%, and that of zidovudine resistance was 9.3%. No lopinavir/ritonavir resistance was recorded. Conclusions: Drug resistance mutations in patients with first-line ART failure had a high prevalence of NNRTI and NRTI resistance but still susceptible to PIs.

Lung Volume Reduction Surgery in Patients with Heterogenous Emphysema: Selecting Perspective.

BACKGROUND: Lung volume reduction surgery (LVRS) was introduced to alleviate clinical conditions in selected patients with heterogenous emphysema. Clarifying the most suitable patients for LVRS remained unclear. AIM: This study was undertaken to specifically analyze the preoperative factor affecting to LVRS. METHODS: The prospective study was conducted at 103 Military Hospital between July 2014 and April 2016. Severe heterogenous emphysema patients were selected to participate in the study. The information, spirometry, and body plethysmographic pulmonary function tests in 31 patients who underwent LVRS were compared with postoperative outcomes (changing in FEV1 and CAT scale). RESULTS: Of the 31 patients, there was statistically significant difference in the outcome of functional capacity, lung function between two groups (FEV1 ≤ 50% and > 50%) (∆FEV1: 22.46 vs 18.32%; p = 0.042. ∆ CAT: 6.85 vs 5.07; p = 0.048). Changes of the FEV1 and CAT scale were no statistically significant differences in three groups residual volume. Patients with total lung capacity < 140% had more improved than others (∆FEV1: 23.81 vs 15.1%; p = 0.031). CONCLUSION: Preoperative spirometry and body plethysmographic pulmonary function tests were useful measures to selected severe heterogenous emphysema patients for LVRS. Patients with FEV1 ≤ 50%, TLC in the range of 100-140% should be selected.

Antibiotic Resistance Profile and Diversity of Subtypes Genes in Escherichia coli Causing Bloodstream Infection in Northern Vietnam.

BACKGROUND: Evaluating the antibiotic susceptibility and resistance genes is essential in the clinical management of bloodstream infections (BSIs). But there are still limited studies in Northern Vietnam. AIM: The aim of the study was to determine the antibiotic resistance profile and characteristics of subtypes genes in Escherichia coli causing BSIs in Northern Vietnam. METHODS: The cross-sectional study was done in the period from December 2012 to June 2014 in two tertiary hospitals in Northern Vietnam. Tests were performed at the lab of the hospital. RESULTS: In 56 E. coli strains isolating 39.29 % produced ESBL. 100% of the isolates harbored blaTEM gene, but none of them had the blaPER gene. The prevalence of ESBL producers and ESBL non-producers in blaCTX-M gene was 81.82%, and 73.53%, in blaSHV gene was 18.18% and 35.29%. Sequencing results showed three blaTEM subtypes (blaTEM 1, 79, 82), four blaCTX-M subtypes (blaCTX-M-15, 73, 98, 161), and eight blaSHV subtypes (blaSHV 5, 7, 12, 15, 24, 33, 57, 77). Antibiotic resistance was higher in ampicillin (85.71%), trimethoprim/sulfamethoxazole (64.29%) and cephazolin (50%). Antibiotics were still highly susceptible including doripenem (96.43%), ertapenem (94.64%), amikacin (96.43%), and cefepime (89.29%). CONCLUSION: In Escherichia coli causing BSIs, antibiotic resistance was higher in ampicillin, trimethoprim/sulfamethoxazole and cephazolin. Antibiotics was highly susceptible including doripenem, ertapenem, amikacin, and cefepime.

Antibiotic Resistance Profile and Methicillin-Resistant Encoding Genes of Staphylococcus aureus Strains Isolated from Bloodstream Infection Patients in Northern Vietnam.

BACKGROUND: Evaluating the antibiotic susceptibility and resistance genes is essential in the clinical management of bloodstream infections (BSIs). Nevertheless, there are still limited studies in Northern Vietnam. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0). AIM: This study aimed to determine the antibiotic resistance profile and methicillin-resistant encoding genes of Staphylococcus aureus (S. aureus) causing BSIs in Northern Vietnam. METHODS: The cross-sectional study was done from December 2012 to June 2014 in two tertiary hospitals in Northern Vietnam. Tests performed at the lab of the hospital. RESULTS: In 43 S. aureus strains isolating, 53.5 % were MRSA. Distribution of gene for overall, MRSA, and MSSA strains were following mecA gene (58.1 %; 95.7%, and 15%), femA gene (48.8%, 47.8%, and 50%), femB gene (88.4%, 82.6%, and 95%). Antibiotic resistance was highest in penicillin (100%), followed by erythromycin (65.1%) and clindamycin (60.5%). Several antibiotics were susceptible (100%), including vancomycin, tigecycline, linezolid, quinupristin/dalfopristin. Quinolone group was highly sensitive, include ciprofloxacin (83.7%), levofloxacin (86%) and moxifloxacin (86%). CONCLUSION: In S. aureus causing BSIs, antibiotic resistance was higher in penicillin, erythromycin, and clindamycin. All strains were utterly susceptible to vancomycin, tigecycline, linezolid, quinupristin/dalfopristin.

The Role of Serial NT-ProBNP Level in Prognosis and Follow-Up Treatment of Acute Heart Failure after Coronary Artery Bypass Graft Surgery.

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.

Cytotoxicity and antiviral activity of electrochemical - synthesized silver nanoparticles against poliovirus.

Silver nanoparticles (AgNPs) have been proven to have noticeable cytotoxicity in vitro and antiviral activity against some types of enveloped viruses. This paper presents the cytotoxicity and antiviral activity of pure AgNPs synthesized by the electrochemical method, towards cell culture and poliovirus (a non-enveloped virus). Prepared AgNPs were characterized by ultraviolet-visible spectroscopy, energy-dispersive X-ray spectroscopy and transmission electron microscopy. Before incubation with poliovirus, different concentrations of AgNPs were added to human rhabdomyosarcoma (RD) cell monolayers seeded in 96 well plates for testing their cytotoxicity. The in vitro cytotoxicity and anti-poliovirus activity of AgNPs were daily assessed for cytopathic effect (CPE) through inverted light microscopy. CPE in the tested wells was determined in comparison with those in wells of negative and positive control. Structure analysis showed that AgNPs were formed with a quasi-spherical shape with mean size about 7.1nm and high purity. No CPE of RD cells was seen in wells at the time point of 48h post-incubation with AgNPs at concentration up to 100ppm. The anti-poliovirus activity of AgNPs was determined at 3.13ppm corresponding to the viral concentration of 1TCID50 (Tissue Culture Infective Dose) after 30min, and 10TCID50 after 60min, the cell viability was found up to 98% at 48h post-infection, with no CPE found. Whereas, a strong CPE of RD cells was found at 48h post-infection with the mixture of AgNPs and poliovirus at concentration of 100TCID50, and in wells of positive controls. With mentioned advantages, electrochemical-synthesized AgNPs are promising candidate for advanced biomedical and disinfection applications.