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Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial.
Bravo, L, Smolenov, I, Han, HH, Li, P, Hosain, R, Rockhold, F, Clemens, SAC, Roa, C, Borja-Tabora, C, Quinsaat, A, et al
Lancet (London, England). 2022;(10323):461-472
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Abstract
BACKGROUND A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019. METHODS This ongoing phase 2 and 3 double-blind, placebo-controlled trial was done in adults aged 18 years and older who were in good health or with a stable chronic health condition, at 31 sites in five countries (Belgium, Brazil, Colombia, Philippines, and South Africa). The participants were randomly assigned 1:1 using a centralised internet randomisation system to receive two 0·5 mL intramuscular doses of SCB-2019 (30 μg, adjuvanted with 1·50 mg CpG-1018 and 0·75 mg alum) or placebo (0·9% sodium chloride for injection supplied in 10 mL ampoules) 21 days apart. All study staff and participants were masked, but vaccine administrators were not. Primary endpoints were vaccine efficacy, measured by RT-PCR-confirmed COVID-19 of any severity with onset from 14 days after the second dose in baseline SARS-CoV-2 seronegative participants (the per-protocol population), and the safety and solicited local and systemic adverse events in the phase 2 subset. This study is registered on EudraCT (2020-004272-17) and ClinicalTrials.gov (NCT04672395). FINDINGS 30 174 participants were enrolled from March 24, 2021, until the cutoff date of Aug 10, 2021, of whom 30 128 received their first assigned vaccine (n=15 064) or a placebo injection (n=15 064). The per-protocol population consisted of 12 355 baseline SARS-CoV-2-naive participants (6251 vaccinees and 6104 placebo recipients). Most exclusions (13 389 [44·4%]) were because of seropositivity at baseline. There were 207 confirmed per-protocol cases of COVID-19 at 14 days after the second dose, 52 vaccinees versus 155 placebo recipients, and an overall vaccine efficacy against any severity COVID-19 of 67·2% (95·72% CI 54·3-76·8), 83·7% (97·86% CI 55·9-95·4) against moderate-to-severe COVID-19, and 100% (97·86% CI 25·3-100·0) against severe COVID-19. All COVID-19 cases were due to virus variants; vaccine efficacy against any severity COVID-19 due to the three predominant variants was 78·7% (95% CI 57·3-90·4) for delta, 91·8% (44·9-99·8) for gamma, and 58·6% (13·3-81·5) for mu. No safety issues emerged in the follow-up period for the efficacy analysis (median of 82 days [IQR 63-103]). The vaccine elicited higher rates of mainly mild-to-moderate injection site pain than the placebo after the first (35·7% [287 of 803] vs 10·3% [81 of 786]) and second (26·9% [189 of 702] vs 7·4% [52 of 699]) doses, but the rates of other solicited local and systemic adverse events were similar between the groups. INTERPRETATION Two doses of SCB-2019 vaccine plus CpG and alum provides notable protection against the entire severity spectrum of COVID-19 caused by circulating SAR-CoV-2 viruses, including the predominating delta variant. FUNDING Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.
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Continuous Subcutaneous Insulin Infusion in Adult Type 1 Diabetes Mellitus Patients: Results from a Public Health System.
Moreno-Fernandez, J, Gomez, FJ, Pinés, P, González, J, López, J, López, LM, Blanco, B, Roa, C, Herranz, S, Muñoz-Rodríguez, JR
Diabetes technology & therapeutics. 2019;(8):440-447
Abstract
Aims: To analyze prevalence and clinical effect of continuous subcutaneous insulin infusion (CSII) in adult type 1 diabetes mellitus (T1DM) patients in a public health system real-world scenario. Materials and Methods: All adult T1DM patients on CSII being followed at Castilla-La Mancha Health Public Service were included. Primary efficacy outcome was the change in HbA1c during the follow-up. Secondary efficacy outcomes included evaluation of the following variables: insulin pump indications, diabetes complication rates, insulin and pump use, continuous glucose monitoring use, patients achieving an HbA1c decrease ≥6 mmol/mol (0.5%) with or without severe hypoglycemia, and discontinuations. Direct patient data were typed through the web-based Spanish national registry on CSII therapy by nine diabetologists from eight different health care areas. Results: A total of 7% of T1DM adult patients were treated with insulin pumps in our region, with a regional prevalence of 18.7 CSII patients/100,000 inhabitants. Three hundred thirteen patients were analyzed with a mean age of 34.1 ± 11.0 years and T1DM duration of 16.6 ± 9.7 years. Mean duration of CSII therapy was 6.2 ± 4.0 years. Data completion was 91.2%. Main indications for treatment were high glucose variability (36%) and suboptimal glycemic control (32%). Mean duration of CSII therapy was 6.2 ± 4.0 years. Sensor-augment pump therapy was used by 26% of the patients. Glycated hemoglobin decreased to -5 mmol/mol (95% CI -6 to -3 mmol/mol; P < 0.001) during the follow-up (Mean difference in change -0.4%, 95% CI -0.5 to -0.2; P < 0.001). Percentage of patients with severe hypoglycemia decreased from 32% to 13% (P < 0.001). Frequent nonsevere hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis were less frequent among patients using higher number of daily basal rates at the study end. The rate of CSII interruption was 3.8%. Conclusions: Prevalence of CSII therapy in our region remains under 10% of adult T1DM patients, although CSII treatment was associated with a sustained improvement in glycemic control.
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Plant Genetic Resources: Needs, Rights, and Opportunities.
Roa, C, Hamilton, RS, Wenzl, P, Powell, W
Trends in plant science. 2016;(8):633-636
Abstract
Technological advances allow us to tap into genetic resources to address food and nutritional security in the face of population growth, urbanization, climate change, and environmental degradation. It is vital, particularly for developing countries, to ensure that the policy framework regulating access and use of genetic resources keeps pace with technological developments.
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Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study.
Sastre, J, Pinés, PJ, Moreno, J, Aguirre, M, Blanco, B, Calderón, D, Herranz, S, Roa, C, Lopez, J, ,
Endocrinologia y nutricion : organo de la Sociedad Espanola de Endocrinologia y Nutricion. 2012;(9):539-46
Abstract
OBJECTIVE To assess glycemic control, the degree of control of cardiovascular risk factors, and treatment schemes used in patients with type 1 diabetes mellitus (T1DM) in Castilla-La Mancha (Spain). PATIENTS AND METHODS A cross-sectional, multicenter study on adult patients with T1DM seen at outpatient endocrinology clinics for 12 months (from September 2009 to August 2010). Diabetes duration was > 5 years in all cases. Sociodemographic, clinical, anthropometric, and laboratory variables were collected, as well as treatment data. A multivariate logistic regression analysis was used to assess variables independently associated to good glycemic control. RESULTS A total of 1465 patients (48.5% women) with a mean age of 39.4±13.5 years and a mean diabetes duration of 19.4±10.6 years, were enrolled. Mean glycosylated hemoglobin (HbA1c) level was 7.8%, and 26% had HbA1c values ≤7%. Predictors of good glycemic control (HBA1c ≤7%) included intensive insulin treatment [odds ratio (OR): 2.56], non-smoking status (OR: 1.66), and a higher educational level (OR: 1.33). Fifteen percent of patients were obese, 35% had dyslipidemia, 23% were hypertensive, and 26% smoked. Four or more of the recommended control goals were achieved by 68% of patients, but more than 33% required additional drug treatment. CONCLUSIONS Glycemic control was inadequate in this cohort of T1DM patients. Promotion of healthy attitudes and intensification of insulin treatment may improve glycemic control. Prevalence of cardiovascular risk factors is high, although a great proportion of patients achieve good lipid and blood pressure control.
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[Effect of intragastric balloon as an alternative method for weight loosing in obese patients].
Oviedo, G, Pompetti, D, Quines, M, Roa, C, Romero, A
Nutricion hospitalaria. 2009;(1):40-5
Abstract
UNLABELLED Obesity has increased worldwide affecting people of all ages and accounting for a severe public health problem. There exist several treatment options for obesity: dietary, pharmacological, physical exercising, psychotherapy, and surgical. Placement of the so-called intragastric ballonn, a silicone device similar to a 600-mL sphere, has been proposed, indicated for patients with a body mass index higher than 30 kg/m(2). OBJECTIVE To assess the effect of the intragastric balloon as an alternative method for weight loosing in obese patients. METHODOLOGY Longitudinal, experimental, descriptive, and exploring study. The sample includes 40 obese patients. Anthropometrical measurements including weight, height, abdominal circumference, tricipital and subscapular folds were done; the body mass index (BMI), muscle surface area and fat a surface area were calculated at baseline, first, third and sixth months after balloon placement. RESULTS The sample comprised 31 women (77.5%) y 9 men (22.5%). The mean age for women was 35.87 years, and for men 44.67 years. At the end of the study, there was a total mean weight reduction of 18.25 kg, BMI 5.95 kg/m(2), abdominal circumference 13.53 cm, and arm circumference 4.14 cm, in both genders; the decrease in anthropometrical measurements was higher in men than women. CONCLUSIONS The intragastric balloon showed to be an effective method for weight loosing in obese patients, with better outcomes in men than women.
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Enteral feeding in stable chronic obstructive pulmonary disease patients.
Tanchoco, CC, Castro, CA, Villadolid, MF, Casiño, G, Rodriguez, MP, Roa, C, de la Cruz, CM, Tangcongco, F
Respirology (Carlton, Vic.). 2001;(1):43-50
Abstract
OBJECTIVE The study aimed to compare the effectiveness of a defined formula diet with a blenderized diet on nutritional and respiratory function parameters and to determine the bacteriological load of the two formulations. METHODOLOGY Seventeen patients, aged 50-75 years, admitted to the University of the Philippines-Philippine General Hospital for chronic bronchitis and/or emphysema, were studied. They were divided into two groups according to dietary regimens. Each group of patients received either the standardized commercial formula or the blenderized formula for 2 weeks. Evaluation of dietary intake, anthropometric measurements, laboratory examinations and lung function were assessed. Subjective evaluation (patient's and physician's assessment) was also sought. Microbiological examinations were performed on the prepared enteral formulas. RESULTS There was a slight increase in weight and in pulmonary function in both groups but these results did not differ significantly. Possible formula contamination was confirmed. Furthermore, in the overall assessment, the physician and patients rated both formulas as comparable.