A SARS-CoV-2 recombinant spike protein vaccine (S-268019-b) for COVID-19 prevention during the Omicron-dominant period: A phase 3, randomised, placebo-controlled clinical trial.

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.

Antidiabetic Activity of Gomphogyne bonii Gagnep. Extract against High-Fat Diet and Alloxan-Induced Type 2 Diabetes in Mice.

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.

Quality of life among advanced cancer patients in Vietnam: a multicenter cross-sectional study.

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.