ABSTRACT
Background: The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50 µg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5 mL in the deltoid region, in a three-dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of the vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Findings: Between March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group. Interpretation: The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8 °C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Funding: Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
ABSTRACT
Introducción: la enfermedad hemorroidal constituye un problema de salud mundial y Cuba; sin embargo, la literatura no recoge información epidemiológica sobre la población cubana. Por lo que este trabajo caracteriza la enfermedad hemorroidal aguda en hospitales cubanos seleccionados, con particular énfasis en los factores de riesgo que favorecen su aparición. Objetivos: identificar los principales factores de riesgo, sus características demográficas y de base; hábitos tóxicos y alimenticios, así como modos y estilos de vida, que favorecen la aparición de una enfermedad hemorroidal aguda. Métodos: se realizó un estudio observacional descriptivo en 11 servicios cubanos de Coloproctología. Se incluyeron 510 pacientes con diagnóstico de enfermedad hemorroidal aguda, con edades comprendidas entre 18 y 75 años, que dieron su consentimiento de participación en el estudio. A todos los pacientes se les aplicó una encuesta epidemiológica que indagaba acerca de los hábitos tóxicos y alimenticios, así como modos y estilos de vida, los cuales son reconocidos como factores de riesgo para la aparición de la enfermedad. Resultados: casi el 75 por ciento de los pacientes comenzó con la enfermedad. Predominaron las hemorroides externas y los signos y síntomas más frecuentes fueron el dolor anal, la sensación de masa, el edema y el sangramiento rectal. La mitad de los pacientes ingiere bebidas alcohólicas y la mayoría consume café, alimentos condimentados y requiere una posición erecta o permanecer sentado durante largos períodos de tiempo, para sus actividades cotidianas. Pocos pacientes consumen altos contenidos de fibras en la dieta, así como abundante agua. Conclusiones: se corrobora la presencia de factores de riesgo e inadecuados modos y estilos de vida en la población cubana que facilitan o propician la aparición de un episodio agudo hemorroidal(AU)
Introduction: hemorrhoidal disease is a global health problem. In Cuba, however, epidemiological data about the population is not available in the literature on the subject. That is the reason why the present paper is aimed at characterizing acute hemorrhoidal disease in selected Cuban hospitals, with particular emphasis on the risk factors leading to its appearance. Objectives: identify the main risk factors, demographic and base features, toxic and eating habits, and life styles and modes, leading to the appearance of acute hemorrhoidal disease. Methods: an observational descriptive study was conducted in 11 Cuban coloproctology services. The sample consisted of 510 patients aged 18-75 diagnosed with acute hemorrhoidal disease, who gave their consent to participate in the study. All patients were given an epidemiological survey about toxic and eating habits, and life styles and modes perceived as risk factors for the disease. Results: almost 75 percent of the patients developed the disease. There was a predominance of external hemorrhoids, and the most common signs and symptoms were anal pain, mass sensation, edema and rectal bleeding. Half the patients consume alcohol and most drink coffee, eat spicy foods and must remain in a standing or sitting position for long periods during their daily activities. Few patients consume a fiber-rich diet and abundant water. Conclusions: corroboration was made of the presence of risk factors and inadequate life styles and modes among the Cuban population which lead to the occurrence of acute hemorrhoidal episodes(AU)
Subject(s)
Humans , Male , Female , Risk Factors , Feeding Behavior/physiology , Hemorrhoids/epidemiology , Life Style/ethnology , Epidemiology, Descriptive , Observational Study , Hemorrhoids/diagnosis , Hospitals/standardsABSTRACT
Introducción: la enfermedad hemorroidal constituye un problema de salud mundial y Cuba; sin embargo, la literatura no recoge información epidemiológica sobre la población cubana. Por lo que este trabajo caracteriza la enfermedad hemorroidal aguda en hospitales cubanos seleccionados, con particular énfasis en los factores de riesgo que favorecen su aparición. Objetivos: identificar los principales factores de riesgo, sus características demográficas y de base; hábitos tóxicos y alimenticios, así como modos y estilos de vida, que favorecen la aparición de una enfermedad hemorroidal aguda. Métodos: se realizó un estudio observacional descriptivo en 11 servicios cubanos de Coloproctología. Se incluyeron 510 pacientes con diagnóstico de enfermedad hemorroidal aguda, con edades comprendidas entre 18 y 75 años, que dieron su consentimiento de participación en el estudio. A todos los pacientes se les aplicó una encuesta epidemiológica que indagaba acerca de los hábitos tóxicos y alimenticios, así como modos y estilos de vida, los cuales son reconocidos como factores de riesgo para la aparición de la enfermedad. Resultados: casi el 75 por ciento de los pacientes comenzó con la enfermedad. Predominaron las hemorroides externas y los signos y síntomas más frecuentes fueron el dolor anal, la sensación de masa, el edema y el sangramiento rectal. La mitad de los pacientes ingiere bebidas alcohólicas y la mayoría consume café, alimentos condimentados y requiere una posición erecta o permanecer sentado durante largos períodos de tiempo, para sus actividades cotidianas. Pocos pacientes consumen altos contenidos de fibras en la dieta, así como abundante agua. Conclusiones: se corrobora la presencia de factores de riesgo e inadecuados modos y estilos de vida en la población cubana que facilitan o propician la aparición de un episodio agudo hemorroidal(AU)
Introduction: hemorrhoidal disease is a global health problem. In Cuba, however, epidemiological data about the population is not available in the literature on the subject. That is the reason why the present paper is aimed at characterizing acute hemorrhoidal disease in selected Cuban hospitals, with particular emphasis on the risk factors leading to its appearance. Objectives: identify the main risk factors, demographic and base features, toxic and eating habits, and life styles and modes, leading to the appearance of acute hemorrhoidal disease. Methods: an observational descriptive study was conducted in 11 Cuban coloproctology services. The sample consisted of 510 patients aged 18-75 diagnosed with acute hemorrhoidal disease, who gave their consent to participate in the study. All patients were given an epidemiological survey about toxic and eating habits, and life styles and modes perceived as risk factors for the disease. Results: almost 75 percent of the patients developed the disease. There was a predominance of external hemorrhoids, and the most common signs and symptoms were anal pain, mass sensation, edema and rectal bleeding. Half the patients consume alcohol and most drink coffee, eat spicy foods and must remain in a standing or sitting position for long periods during their daily activities. Few patients consume a fiber-rich diet and abundant water. Conclusions: corroboration was made of the presence of risk factors and inadequate life styles and modes among the Cuban population which lead to the occurrence of acute hemorrhoidal episodes(AU)
