Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants.

BACKGROUND AND AIMS: ROTAVIN-M1® (licensed, frozen vaccine) and ROTAVIN (second-generation, liquid candidate vaccine) are two rotavirus vaccine formulations developed from a live attenuated G1P8 (KH0118) strain by Center for Research and Production of Vaccines and Biologicals (POLYVAC), Vietnam. This study compared the safety and immunogenicity of these two formulations. METHODS: A Phase 3, randomized, partially double-blinded, active-controlled study was conducted in healthy infants aged 60-91 days in Vietnam. Infants received two doses of ROTAVIN or ROTAVIN-M1 in a ratio of 2:1 with an interval of 8 weeks. Solicited reactions were collected for 7 days after each vaccination. Blood samples were collected pre-vaccination and 4 weeks after the second vaccination in a subset of infants. Non-inferiority criteria required that the lower bound of 95% confidence intervals (CIs) of the post-vaccination anti-rotavirus IgA GMC (Geometric Mean Concentration) ratio of ROTAVIN/ROTAVIN-M1 should be >0.5. A co-primary objective was to compare the safety of the two vaccines in terms of solicited reactions. RESULTS: A total of 825 infants were enrolled. The post-vaccination GMC was 48.25 (95% CI: 40.59, 57.37) in the ROTAVIN group and 35.04 (95% CI: 27.34, 44.91) in the ROTAVIN-M1 group with an IgA GMC ratio of 1.38 (95% CI: 1.02, 1.86) thus meeting the pre-set criteria for non-inferiority. A total of 605 solicited reactions were reported in 297 (36.0%) participants with 35.4% in the ROTAVIN group and 37.2% in the ROTAVIN-M1 group. There were no cases of intussusception or death reported in the study. CONCLUSIONS: Based on the data generated, it can be concluded that ROTAVIN is immunologically non-inferior and has similar safety profile to ROTAVIN-M1 when administered to infants in a two-dose schedule. Therefore, it can be considered as a more suitable option for programmatic use to prevent rotavirus diarrhoea in Vietnam and the Mekong region. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT03703336, October 11, 2018.

Effects of Fermentation Conditions Using Lactobacillus plantarum on the Charantin, Stigmasterol Glucoside and ß-sitosterol Glucoside Contents of Bitter Gourd (Momordica charantia L.) Juice.

Bitter gourd fruits contain high amounts of charantin, stigmasterol glucoside and ß-sitosterol glucoside, which have been shown to provide health benefits for humans. However, the bitterness of the fruit means they are rarely consumed. This study aimed to assess the effects of Lactobacillus plantarum fermentation, which has previously been reported to effectively reduce bitterness, on the contents of these compounds. The current results suggest that Lactobacillus plantarum fermentation should be considered as a potential approach to enhance the levels of these compounds in bitter gourd juice.

Properties of Pectin Extracted from Vietnamese Mango Peels.

This study was carried out to investigate the properties of pectin extracted from Vietnamese mango peels that have been discarded as waste. Three different mango cultivars named Hoa Loc, Ghep and Cat Chu at three different maturities were studied. Pectin extracted from immature, ripe and overripe stages ranged from 18.4 to 31.7 g/100 g dry weight (DW); the highest yields were obtained from the ripe fruits. Ghep peels contained the highest pectin amounts which ranged from 24.2 to 31.7 g/100 g DW, followed by Cat Chu (19.2 to 26.5 g/100 g DW) and Hoa Loc peels (18.4 to 24.1 g/100 g DW). Except for degree of esterification and emulsion capacity, other properties of the extracted pectin including water holding capacity, solubility and emulsion stability were significantly affected by the fruit maturation. Varieties, solubility, degree of esterification, emulsion activity and emulsion stability of the pectin isolated from the three cultivars ranged from 77.4% to 86.0%; 50.3% to 55.8%; 11.8% to 34.3% and 28.5% to 94.5%, respectively. Fourier-transform infrared results showed that almost all collected pectin samples could be classified as the high methoxyl pectin. Rheology data indicated viscosity of the isolated pectin was strongly dependent on temperatures.

Effects of Maturity at Harvest and Fermentation Conditions on Bioactive Compounds of Cocoa Beans.

Cocoa beans and cocoa products contain considerable amounts of bioactive compounds. Harvesting cocoa fruit too early or too late may have effects on the phenolic and alkaloid concentrations of the cocoa powder. Fermentation, a primary processing used to transform cocoa beans to cocoa powder, may also influence the contents of bioactive compounds. In this study, proanthocyanidins, the major compounds in cocoa polyphenols, caffeine and theobromine of cocoa beans, were evaluated at different maturities at harvest, and with different fermentation durations, with and without the addition of a commercial enzyme, Pectinex® Ultra SP-L. The amounts of proanthocyanidins, caffeine and theobromine, and the antioxidant capacities of the unfermented cocoa beans increased as the fruits matured. The values ranged from 16.12-27.28 g catechin equivalents (CE)/100 g dry weight (DW); 99.66-173.61 mg/100 g DW; 556.39-948.84 mg/100 g DW; 23.23-26.32 mol Trolox equivalents (TE)/100 g DW, respectively. Prolonged fermentation with or without the addition of pectinase, from three to seven days, significantly reduced the amounts of these compounds present. Fermentation using the enzyme significantly reduced the proanthocyanidin content and antioxidant capacity of the cocoa powder, with the overall means decreasing from 8.93-4.93 g CE/100 g DW and from 15.81-12.95 g mol TE/100 g DW, respectively. Two-way ANOVA analyses showed that the proanthocyanidins, caffeine, theobromine contents and the antioxidant capacity of cocoa beans were strongly dependet to their stages of maturity, fermentation methods and fermentation duration.

Effects of Juice Processing on Oxalate Contents in Carambola Juice Products.

Effects of processing methods including pressing, enzyme-assisted extraction, lactic acid fermentation by Lactobacillus acidophilus, and alcohol fermentation by Saccharomyces cerevisiae on total and soluble oxalate contents of carambola juices were studied. In comparison with pressing, the use of enzyme increased juice yields (15.89-17.29%), but resulted in higher total oxalate (1.60-1.73 times) and soluble oxalate contents (1.16-1.49 times). In addition, extension of enzyme incubation periods led to an increase in soluble oxalate contents in the products (p < 0.05). On the other hand, alcohol fermentation with Saccharomyces cerevisiae from 1 to 5 weeks reduced 37-58% of total oxalate and 39-59% of soluble oxalate contents. Prolonged fermentation also demonstrated better reduction of oxalate contents. Meanwhile, lactic acid fermentation using Lactobacillus acidophilus had no effects on total and soluble oxalate contents in carambola juices. These results suggested that carambola juice products should only be consumed moderately, and that alcohol fermentation could be a potential method to reduce oxalate contents in foods in order to prevent the risks of forming kidney stones.

Actinic light and pH effect on the proton pumping of bacteriorhodopsin.

The actinic light effect on the bacteriorhodopsin (BR) photocycle kinetics led to the assumption of a cooperative interaction between the photocycling BR molecules. In this paper we report the results of the actinic light effect and pH on the proton release and uptake kinetics. An electrical method is applied to detect proton release and uptake during the photocycle [E. Papp, G. Fricsovszky, J. Photochem. Photobiol. B: Biol. 5 (1990) 321]. The BR photocycle kinetics was also studied by absorption kinetics measurements at 410 nm and the data were analyzed by the local analysis of the M state kinetics [E. Papp, V.H. Ha, Biophys. Chem. 57 (1996) 155]. While at high pH and ionic strength, we found a similar behavior as reported earlier, at low ionic strength the light effect proved to be more complex. The main conclusions are the following: Though the number of BR excited to the photocycle (fraction cycling, fc) goes to saturation with increasing laser pulse energy, the absorbed energy by BR increases linearly with pulse energy. From the local analysis we conclude that the light effect changes the kinetics much earlier, already at the L intermediate state decay. The transient electric signal, caused by proton release and uptake, can be decomposed into two components similarly to the absorption kinetic data of the M intermediate state. The actinic light energy affects mainly the ratio of the two components and the proton movements inside BR while pH has an effect on the kinetics of the proton release and uptake groups at the membrane surface.