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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.
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Introducción: las lesiones intraepiteliales cervicales son precursoras del cáncer de cuello uterino, enfermedad que causó 465 muertes en Cuba en el año 2015. Objetivo: describir la evolución de las lesiones intraepiteliales de bajo grado del cérvix durante un bienio según lo dispuesto en el Programa Nacional de Diagnóstico Precoz del Cáncer Cervicouterino. Métodos: se realizó un estudio descriptivo, longitudinal y prospectivo a 79 pacientes diagnosticadas citológicamente con una lesión escamosa intraepitelial de bajo grado en el período comprendido entre el 1ro de septiembre de 2012 y el 31 de agosto de 2013 en el Hospital Materno Ramón González Coro. Seguimiento evolutivo cada seis meses durante dos años. Resultados: 54,4 por ciento tenía entre 25 y 39 años de edad. Del total, 65,8 por ciento negativizó la citología entre los 6 y 18 meses. En los dos años de evolución, 25,3 por ciento del total progresó a una lesión de alto grado. Existió buena correlación citocolposcópica en 80 por ciento de las pacientes. El cálculo de la mediana de la zona transformación atípica en las lesiones de alto grado fue de 25 por ciento, muy superior a las de bajo grado. Hubo confirmación histológica en todos los casos cuya lesión progresó. Conclusiones: las pacientes que negativizaron la citología lo hizo durante los 18 meses de seguimiento. Existió buena relación citohistológica, no así colpohistológica. La evolución no guardó relación con las variables sociodemográficas excepto con el uso de DIU. Lesiones que ocupan más del 20 por ciento de la zona de transformación se relacionó con progresión hacia una lesión escamosa intraepitelial de alto grado(AU)
Introduction: Cervical intraepithelial lesions are signs of cervical cancer, a disease that caused 465 deaths in Cuba in 2015. Objective: To describe the evolution of low-grade intraepithelial lesions of the cervix during a biennium according to the provisions of the National Program of Early Diagnosis of Cervical Cancer. Methods: A descriptive, longitudinal and prospective study was carried out on 79 patients diagnosed by cytology with a low-grade squamous intraepithelial lesion from September 1, 2012 to August 31, 2013 at Ramón González Coro Gyneco-Obstetric Hospital. These subjects received an evolutionary follow-up every six months for two years. Results: 54.4 percent were between 25 and 39 years of age; 65.8 percent had negative cytology between 6 and 18 months. In the two years of evolution, 25.3 percent of the total progressed to a high-grade lesion. There was good cytocolposcopic correlation in 80 percent of the patients. The calculation of the median of the atypical transformation zone in the high-grade lesions was 25 percent, much higher than the low-grade ones. There was histological confirmation in all cases whose lesion progressed. Conclusions: Negative cytology in our patients was assessed during the 18 months of follow-up period. There was good cytohistological relationship, but not so for colpohistological relationship. The evolution was not related to the sociodemographic variables except with the use of IUD. Lesions that occupy more than 20 percent of the transformation zone were associated with progression towards a high-grade squamous intraepithelial lesion(AU)
Assuntos
Humanos , Feminino , Adulto , Lesões Intraepiteliais Escamosas Cervicais/patologia , Lesões Intraepiteliais Escamosas Cervicais/epidemiologia , Epidemiologia Descritiva , Estudos Retrospectivos , Estudos Longitudinais , Colposcopia/métodos , Lesões Intraepiteliais Escamosas CervicaisRESUMO
Introducción: las lesiones intraepiteliales cervicales son precursoras del cáncer de cuello uterino, enfermedad que causó 465 muertes en Cuba en el año 2015. Objetivo: describir la evolución de las lesiones intraepiteliales de bajo grado del cérvix durante un bienio según lo dispuesto en el Programa Nacional de Diagnóstico Precoz del Cáncer Cervicouterino. Métodos: se realizó un estudio descriptivo, longitudinal y prospectivo a 79 pacientes diagnosticadas citológicamente con una lesión escamosa intraepitelial de bajo grado en el período comprendido entre el 1ro de septiembre de 2012 y el 31 de agosto de 2013 en el Hospital Materno Ramón González Coro. Seguimiento evolutivo cada seis meses durante dos años. Resultados: 54,4 por ciento tenía entre 25 y 39 años de edad. Del total, 65,8 por ciento negativizó la citología entre los 6 y 18 meses. En los dos años de evolución, 25,3 por ciento del total progresó a una lesión de alto grado. Existió buena correlación citocolposcópica en 80 por ciento de las pacientes. El cálculo de la mediana de la zona transformación atípica en las lesiones de alto grado fue de 25 por ciento, muy superior a las de bajo grado. Hubo confirmación histológica en todos los casos cuya lesión progresó. Conclusiones: las pacientes que negativizaron la citología lo hizo durante los 18 meses de seguimiento. Existió buena relación citohistológica, no así colpohistológica. La evolución no guardó relación con las variables sociodemográficas excepto con el uso de DIU. Lesiones que ocupan más del 20 por ciento de la zona de transformación se relacionó con progresión hacia una lesión escamosa intraepitelial de alto grado(AU)
Introduction: Cervical intraepithelial lesions are signs of cervical cancer, a disease that caused 465 deaths in Cuba in 2015. Objective: To describe the evolution of low-grade intraepithelial lesions of the cervix during a biennium according to the provisions of the National Program of Early Diagnosis of Cervical Cancer. Methods: A descriptive, longitudinal and prospective study was carried out on 79 patients diagnosed by cytology with a low-grade squamous intraepithelial lesion from September 1, 2012 to August 31, 2013 at Ramón González Coro Gyneco-Obstetric Hospital. These subjects received an evolutionary follow-up every six months for two years. Results: 54.4 percent were between 25 and 39 years of age; 65.8 percent had negative cytology between 6 and 18 months. In the two years of evolution, 25.3 percent of the total progressed to a high-grade lesion. There was good cytocolposcopic correlation in 80 percent of the patients. The calculation of the median of the atypical transformation zone in the high-grade lesions was 25 percent, much higher than the low-grade ones. There was histological confirmation in all cases whose lesion progressed. Conclusions: Negative cytology in our patients was assessed during the 18 months of follow-up period. There was good cytohistological relationship, but not so for colpohistological relationship. The evolution was not related to the sociodemographic variables except with the use of IUD. Lesions that occupy more than 20 percent of the transformation zone were associated with progression towards a high-grade squamous intraepithelial lesion(AU)
Assuntos
Humanos , Feminino , Adulto , Lesões Intraepiteliais Escamosas Cervicais/patologia , Lesões Intraepiteliais Escamosas Cervicais/epidemiologia , Epidemiologia Descritiva , Estudos Retrospectivos , Estudos Longitudinais , Colposcopia/métodos , Lesões Intraepiteliais Escamosas Cervicais/diagnóstico por imagemRESUMO
Introducción: la condilomatosis genital es la expresión clínica más frecuente de del virus del papiloma humano. De las alternativas de tratamiento existentes, no hay una de elección y absolutamente eficaz. Objetivo: describir la seguridad y el efecto del Interferón alfa recombinante, en el tratamiento de las verrugas genitales. meses mediante la curva de Kaplan-Meier. ..
Introduction: the genital condyloma is the more frequent clinical expression or the human papilloma virus. From the available alternative of treatment there is not one of election and totally effective. Objective: to describe the safety and the effect of recombinant alfa-Interferon in treatment of genital warts. Methods: a quasi-experimental study was conducted in 216 women and in 111 men. The above mentioned Interferon was applied in the basement of warts at a dose of 10 millions of international units weekly during 8-16 weeks...
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Humanos , Masculino , Feminino , Pré-Escolar , Adulto , Condiloma Acuminado/tratamento farmacológico , Interferon-alfa/uso terapêutico , Infecções por Papillomavirus/tratamento farmacológico , Infecções por Papillomavirus/radioterapia , Saúde ReprodutivaRESUMO
Introducción: la condilomatosis genital es la expresión clínica más frecuente de del virus del papiloma humano. De las alternativas de tratamiento existentes, no hay una de elección y absolutamente eficaz. Objetivo: describir la seguridad y el efecto del Interferón alfa recombinante, en el tratamiento de las verrugas genitales. meses mediante la curva de Kaplan-Meier. ..
Introduction: the genital condyloma is the more frequent clinical expression or the human papilloma virus. From the available alternative of treatment there is not one of election and totally effective. Objective: to describe the safety and the effect of recombinant alfa-Interferon in treatment of genital warts. Methods: a quasi-experimental study was conducted in 216 women and in 111 men. The above mentioned Interferon was applied in the basement of warts at a dose of 10 millions of international units weekly during 8-16 weeks...
Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Adulto , Condiloma Acuminado/tratamento farmacológico , Interferon-alfa , Infecções por Papillomavirus/tratamento farmacológico , Infecções por Papillomavirus/radioterapia , Saúde ReprodutivaRESUMO
Estudio retrospectivo, que incluyó a las 320 adolescentes atendidas en el servicio de interrupción de embarazo del HDG Clodomira Acosta, mediante el método de atención diferencial, en el período de enero a diciembre de 1996. Se realizó una comparación de variables con un grupo de control de 320 pacientes mayores de 20 años, atendidas en este mismo servicio, sin los rigores de la atención diferenciada.Se exponen al final del trabajo los resultados y discusión
