Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma.

BACKGROUND: To compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence. METHODS: Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Secondary endpoints included relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity. RESULTS: The ITT population comprised 110 participants, with 56 randomized to NY-ESO-1/ISCOMATRIX and 54 to ISCOMATRIX alone. No significant toxicities were observed. There were no differences between the study arms in relapses at 18 months or for median time to relapse; 139 vs 176 days (p=0.296), or relapse rate, 27 (48.2%) vs 26 (48.1%) (HR 0.913; 95% CI 0.402 to 2.231), respectively. RFS and OS were similar between the study arms. Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4+ and CD8+ responses. Biopsies following relapse did not demonstrate differences in NY-ESO-1 expression between the study populations although an exploratory study demonstrated reduced (NY-ESO-1)+/Human Leukocyte Antigen (HLA) class I+ double-positive cells in biopsies from vaccine recipients performed on relapse in 19 participants. CONCLUSIONS: The vaccine was well tolerated, however, despite inducing antigen-specific immunity, it did not affect survival endpoints. Immune escape through the downregulation of NY-ESO-1 and/or HLA class I molecules on tumor may have contributed to relapse

Comment on Hogas et al. Salt, Not Always a Cardiovascular Enemy? A Mini-Review and Modern Perspective. Medicina 2022, 58, 1175

Hogas et al. recently published their perspective on dietary salt in a mini review [...

24-hour sodium and potassium excretion in the Americas: a systematic review and meta-analysis.

OBJECTIVE: To determine the 24-hour urinary sodium and potassium excretions in the Americas. METHODS: A systematic review and meta-analysis were performed seeking for studies conducted between 1990 and 2021 in adults living in any sovereign state of the Americas in Medline, Embase, Scopus, SciELO, and Lilacs. The search was first run on October 26th, 2020 and was updated on December 15th, 2021. Of 3 941 abstracts reviewed, 74 studies were included from 14 countries, 72 studies reporting urinary sodium (27 387 adults), and 42 studies reporting urinary potassium (19 610 adults) carried out between 1990 and 2020. Data were pooled using a random-effects meta-analysis model. RESULTS: Mean excretion was 157.29 mmol/24h (95% CI, 151.42-163.16) for sodium and 57.69 mmol/24h (95% CI, 53.35-62.03) for potassium. When only women were considered, mean excretion was 135.81 mmol/24h (95% CI, 130.37-141.25) for sodium and 51.73 mmol/24h (95% CI, 48.77-54.70) for potassium. In men, mean excretion was 169.39 mmol/24h (95% CI, 162.14-176.64) for sodium and 62.67 mmol/24h (95% CI, 55.41-69.93) for potassium. Mean sodium excretion was 150.09 mmol/24h (95% CI, 137.87-162.30) in the 1990s and 159.79 mmol/24h (95% CI, 151.63-167.95) in the 2010s. Mean potassium excretion was 58.64 mmol/24h (95% CI, 52.73-64.55) in the 1990s and 56.33 mmol/24/h (95% CI, 48.65-64.00) in the 2010s. CONCLUSIONS: These findings suggest that sodium excretions are almost double the maximum level recommended by the World Health Organization and potassium excretions are 35% lower than the minimum requirement; therefore, major efforts to reduce sodium and to increase potassium intakes should be implemented

Nutrition Profile of Products with Cartoon Animations on the Packaging: A UK Cross-Sectional Survey of Foods and Drinks.

BACKGROUND: Marketing, including the use of cartoon animations on packaging, has been shown to influence the food children choose to eat. This paper aims to determine the nutritional quality of UK food and drink products featuring child-friendly characters on pack. METHODS: A comprehensive cross-sectional survey of food and drink with packaging appealing to children available in the UK. Products were classified high in fat, salt and/or sugar (HFSS) according to the UK nutrient profiling model and guidance for front of pack nutrition labelling. Logistic regression was used to determine whether there was a significant relationship between nutritional quality of products, and animation type. RESULTS: Over half (51%) of 532 products with animations on packaging were classified as HFSS. Food products featuring unlicensed characters were significantly more likely to be deemed HFSS than those with licensed characters, according to both the nutrient profiling model (odds ratio (OR) 2.1, 95% CI: 1.3 to 3.4) and front of pack nutrition labelling system (OR 2.3, 95% confidence interval CI: 1.4 to 3.7). CONCLUSIONS: The use of cartoon characters on HFSS products is widespread. Policies to restrict the use of such marketing tactics should be considered to prevent children being targeted with unhealthy foods and drinks

Salt content of instant noodles in Malaysia: a cross-sectional study

Objective To determine the salt content in instant noodles sold in Malaysia. Study design A cross-sectional survey was done involving 707 different flavours and packaging of instant noodles sold in six hypermarkets and retailer chains in Malaysia and the corresponding brand's official websites in 2017. Methods The salt content (gram per serving and per 100 g) was collected from the product packaging and corresponding brand's official website. Results Of the 707 different packaging and flavours of instant noodles, only 62.1% (n=439) provided the salt content in their food label. The mean (±SD) salt per 100 g of instant noodles was 4.3±1.5 g and is nearly four times higher than the salt content of food classified in Malaysia as a high salt content (>1.2 g salt per 100 g). The salt content for instant noodle per packaging ranged from 0.7 to 8.5 g. 61.7% of the instant noodles exceeded the Pacific Salt Reduction Target, 11.8% exceeded the WHO recommended daily salt intake of <5.0 per day and 5.50% exceeded Malaysia Salt Action Target. 98% of instant noodles will be considered as high salt food according to the Malaysia Guidelines. The probability of the instant noodles without mixed flavour (n=324) exceeding the Pacific Salt Reduction Target was tested on univariate and multivariate analysis. Instant noodles with soup, Tom Yam flavour, pork flavour and other flavours were found to be predictors of instant noodles with the tendency to exceed Pacific Salt Reduction Target when compared with instant noodles without mixed flavours (p<0.05). Conclusion Only 62% of instant noodles displayed the salt content on their food label. Salt content in instant noodles is very high, with 90% exceeding the daily salt intake recommended by WHO. Prompt action from regulatory and health authorities is needed to reduce the salt content in instant noodles. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ

Action on Salt China

National Institute of Health Research using Official Development Assistance (ODA