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1.
Vaccine ; 42(17): 3699-3709, 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38734495

ABSTRACT

Clinical trials of new vaccines based on existing variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) are often impacted by the emergence of new virus variants. We evaluated the efficacy, immunogenicity, and safety of S-268019-b, a recombinant spike protein subunit vaccine based on the ancestral strain, for preventing symptomatic coronavirus disease 2019 (COVID-19) during the Omicron (BA.2)-dominant period in Vietnam. In this multicentre, phase 3, randomised (2:1), observer-blind, placebo-controlled crossover study, participants received 2 intramuscular doses (28 days apart) of either 10 µg of S-268019-b (Recombinant S-protein vaccine) or placebo. The primary endpoint was incidence of laboratory-confirmed symptomatic COVID-19 before crossover, with onset within 14 days following the second dose, in participants who were seronegative and reverse transcription polymerase chain reaction (RT-PCR)-negative at baseline. The secondary endpoints included immunogenicity and safety. In total, 8,594 participants were randomised (S-268019-b [n = 5,727]; placebo [n = 2,867]). Vaccine efficacy versus placebo was 39·1 % (95 % confidence interval [CI]:26·6-49·5; one-sided P = 0·0723). The incidence rate (95 % CI) of symptomatic COVID-19 was 776·41/1,000 person-years (682·04-880·19) in the S-268019-b group and 1272·87/1,000 person-years (1101·32-1463·57) in the placebo group. The geometric mean titres (95 % CI) of the SARS-CoV-2 neutralising antibody increased on Day 57 versus baseline with S-268019-b (34·66 [27·04-44·41] versus 2·50 (non-estimable) but not with placebo. There were no safety concerns regarding S-268019-b. S-268019-b did not demonstrate the targeted efficacy threshold against symptomatic COVID-19; however, findings were comparable with other prophylactic vaccines based on ancestor strain during the Omicron-dominant period. S-268019-b demonstrated immunogenicity and was well-tolerated. ClinicalTrials.gov identifier: NCT05212948.


Subject(s)
Antibodies, Viral , COVID-19 Vaccines , COVID-19 , Immunogenicity, Vaccine , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Vaccines, Synthetic , Humans , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , COVID-19/immunology , Male , Female , Adult , Spike Glycoprotein, Coronavirus/immunology , Spike Glycoprotein, Coronavirus/genetics , SARS-CoV-2/immunology , SARS-CoV-2/genetics , Middle Aged , Antibodies, Viral/blood , Antibodies, Viral/immunology , Vaccines, Synthetic/immunology , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vietnam , Young Adult , Cross-Over Studies , Adolescent , Vaccine Efficacy , Aged , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , Vaccines, Subunit
2.
Article in English | MEDLINE | ID: mdl-34880923

ABSTRACT

So far, diabetes mellitus has become a health threat to society all over the world. Especially, people with diabetes have always coped with complications related to this disease and unexpected side effects of synthetic drugs. Thus, there has been a current trend for researchers to find out new natural ingredients which were safer and still effective in the treatment of diabetes. Gomphogyne bonii Gagnep. extract (G. bonii extract) was an herbal-derived product of the Pharmacy Department, Vietnam University of Traditional Medicine. This study was designed to assess the antidiabetic effect of G. bonii extract on a high-fat diet (HFD) and alloxan-induced diabetes in mice. Mice were first fed a high-fat diet for 8 weeks and then given an intraperitoneal injection of alloxan (ALX) at the dose of 180 mg/kg b.w. After the diabetic mice model was successfully established, mice were administered orally with G. bonii extract at two doses of 4 mL/kg b.w/day and 12 mL/kg b.w/day for 2 weeks. The results revealed that G. bonii extract at both doses ameliorated the effects of ALX on the concentration of glucose, total cholesterol (TC), triglyceride (TG), and low-density lipoprotein-cholesterol (LDL-C) and microhistological images of livers. Besides, the antidiabetic effect of G. bonii extract at the dose of 12 mL/kg b.w/day was better than that at the dose of 4 mL/kg b.w/day. This suggested that G. bonii extract could be a potential agent for treating diabetes mellitus in clinical practice.

3.
Article in English | MEDLINE | ID: mdl-33976702

ABSTRACT

Dyslipidemia substantially contributes to the risk of cardiovascular diseases. The polyherbal formulation has been a traditional therapeutic strategy used to treat dyslipidemia. This study was designed to evaluate the effects of a novel herbal medicine called "GANMO" on an experimental animal model with endogenous dyslipidemia and exogenous dyslipidemia. In the endogenous hyperlipidemia model, rats were previously treated with GANMO tablets and intraperitoneally injected with poloxamer 407 to induce hyperlipidemia. In the exogenous hyperlipidemia model, rats were given oral administration of oil-cholesterol mixture and GANMO for 4 consecutive weeks. Serum lipid profiles were assessed at all experimental animals. In both models, GANMO at both doses significantly decreased the serum total cholesterol (TC) level and non-high-density lipoprotein (HDL) cholesterol level as compared with the model group. HDL cholesterol levels increased in rats with high doses of GANMO compared to those with low doses. GANMO at both doses substantially reduced TG level in the endogenous hyperlipidemia model. In conclusion, GANMO tablets posed a positive effect on serum lipid modulations in dyslipidemia models.

4.
Support Care Cancer ; 29(8): 4791-4798, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33537888

ABSTRACT

PURPOSE: Cancer is a leading cause of death in Vietnam. To maximize quality of life (QOL) at the end of life, valid and clinically useful instruments are needed to assess palliative care needs and the effectiveness of palliative care interventions. METHODS: We aimed to (i) determine psychometric properties of the Vietnamese version of the WHO abbreviated quality of life scale (WHOQOL-BREFVN) among advanced cancer patients, (ii) measure HR-QOL, and (iii) identify predictors of HR-QOL. We collected demographic, clinical, and HR-QOL data from stage III/IV adult cancer patients at two major Vietnamese cancer centers. We determined the internal consistency (Cronbach's alpha), construct validity (confirmatory factor analysis (CFA)), and discriminant validity (known-groups comparison) of the Vietnamese instrument. HR-QOL was analyzed descriptively. Multinomial logistic regressions identified predictors of HR-QOL. RESULTS: A total of 825 patients participated. Missing data were completely at random (MCAR) (chi-square = 14.270, df = 14, p = 0.430). Cronbach's alpha for all items was 0.904. CFA loadings of physical, psychological, social relationship, and environment domains onto HR-QOL were 0.81, 0.82, 0.34, and 0.75, respectively. Prediction of scores differed significantly by functional status (Wilks' lambda = 0.784, chi-square = 197.546, df = 4, p < 0.01, correct prediction = 74.6%). HR-QOL was reported as very bad/bad by n = 188 patients (22.8%) and general health as very bad/bad by n = 430 (52.1%). Multinomial logistic regression (likelihood ratio test: chi-square = 35.494, df = 24, p = 0.061, correct prediction = 62.2%) and the Pearson correlations revealed worse HR-QOL was associated with inpatient status, high ECOG score, and having dependent children. CONCLUSION: The Vietnamese version of the WHOQOL-BREF has excellent internal consistency reliability and sound construct and discriminant validity in advanced cancer patients. Advanced cancer inpatients, those with dependent children, and those with poorer physical function appear to have the greatest palliative care needs.


Subject(s)
Neoplasms/psychology , Quality of Life/psychology , Adult , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Reproducibility of Results , Self Report , Vietnam , Young Adult
5.
Article in English | WPRIM (Western Pacific) | ID: wpr-1012268

ABSTRACT

@#Introduction: Hospitals are a key source of information for the early identification of emerging disease outbreaks and acute public health events for risk assessment, decision-making and public health response. The objective of this study was to identify potential facilitators and barriers for event reporting from the curative sector to the preventive medicine sector in Viet Nam. Methods: In 2016, we conducted 18 semi-structured, in-depth interviews, as well as nine focus group discussions, with representatives from the curative and preventive medicine sectors in four provinces. We transcribed the interviews and focus group discussions and used thematic analysis to identify the factors that appeared to affect public health event reporting. Results: We identified five major themes. First, the lack of a legal framework to guide reporting meant hospital staff relied on internal procedures that varied from hospital to hospital, which sometimes delayed reporting. Second, participants stated the importance of an enabling environment, such as leadership support and having focal points for reporting, to facilitate reporting. Third, participants described the potential benefits of reporting, such as support provided during outbreaks and information received about local outbreaks. Fourth, some challenges prohibited timely reporting such as not perceiving reporting to be the task of the curative sector and hesitancy to report without laboratory confirmation. Finally, limited resources and specialist capacities in remote areas hindered timely detection and reporting of unusual events. Discussion: This study identified potential opportunities to promote the detection and reporting of unusual events from health-care workers to the public health sector, and thus to improve the overall health security system in Viet Nam.The influenza virus is a respiratory pathogen that is transmitted through respiratory droplets.1 During seasonal influenza epidemics, high attack rates cause a significant public health burden.2 The infection is usually self-limited in young adults but can lead to severe infections in people in high-risk groups, including elderly people (> 65 years old), pregnant women, children aged 6–59 months and adults with chronic illnesses.3

6.
J Pain Symptom Manage ; 55(2S): S92-S95, 2018 02.
Article in English | MEDLINE | ID: mdl-28803076

ABSTRACT

Palliative care began in Vietnam in 2001, but steady growth in palliative care services and education commenced several years later when partnerships for ongoing training and technical assistance by committed experts were created with the Ministry of Health, major public hospitals, and medical universities. An empirical analysis of palliative care need by the Ministry of Health in 2006 was followed by national palliative care clinical guidelines, initiation of clinical training for physicians and nurses, and revision of opioid prescribing regulations. As advanced and specialist training programs in palliative care became available, graduates of these programs began helping to establish palliative care services in their hospitals. However, community-based palliative care is not covered by government health insurance and thus is almost completely unavailable. Work is underway to test the hypothesis that insurance coverage of palliative home care not only can improve patient outcomes but also provide financial risk protection for patients' families and reduce costs for the health care system by decreasing hospital admissions near the end of life. A national palliative care policy and strategic plan are needed to maintain progress toward universally accessible cost-effective palliative care services.


Subject(s)
Palliative Care , Analgesics, Opioid/therapeutic use , Health Personnel/education , Health Policy , Health Services Accessibility/economics , Humans , Insurance, Health , Palliative Care/economics , Palliative Care/methods , Vietnam
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