Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial.

Background: SOBERANA-02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phases 1/2 clinical trials demonstrated high immunogenicity, promoting neutralising IgG and specific T-cell response. A third heterologous dose of SOBERANA-Plus (RBD-dimer) further increased neutralising antibodies. The aim of this study is to evaluate the safety and efficacy of two immunisation regimes: two doses of SOBERANA-02 and a heterologous three-dose combination with SOBERANA-Plus added to it. Methods: From March 8th to June 24th, 2021 we conducted in Havana, Cuba a multicentre randomised, double-blind, placebo-controlled, phase-3 trial evaluating a two doses SOBERANA-02 scheme and a heterologous scheme with one dose SOBERANA-Plus added to it (RPCEC00000354). Participants 19-80 years were randomly assigned to receiving 28 days apart either the two or three dose scheme or placebo. The main endpoint was vaccine efficacy in preventing the occurrence of RT-PCR confirmed symptomatic COVID-19 at least 14 days after the second or third dose in the per-protocol population. We also assessed efficacy against severe disease and, in all participants receiving at least one vaccine/placebo dose, safety for 28 days after each dose. Findings: We included 44,031 participants (52.0% female, 48.0% male; median age 50 years, range 19-80 years; 7.0% black, 24.0% mixed-race, 59.0% white) in a context of initial Beta VOC predominance, with this variant being partially replaced by Delta near the trial's end. Vaccine efficacy in the heterologous combination was 92.0% (95%CI 80.4-96.7) against symptomatic disease. There were no severe COVID-19 cases in the vaccine group against 6 in the placebo group. Two doses of SOBERANA-02 was 69.7% (95%CI 56.5-78.9) and 74.9% (95%CI 33.7-90.5) efficacious against symptomatic and severe COVID-19, respectively. The occurrence of serious and severe adverse events (AE) was very rare and equally distributed between placebo and vaccine groups. Solicited AEs were slightly more frequent in the vaccine group but predominantly local and mostly mild and transient. Interpretation: Our results indicate that the straightforward to manufacture SOBERANA vaccines are efficacious in a context of Beta and Delta VOC circulation, have a favourable safety profile, and may represent an attractive option for use in COVID-19 vaccination programmes. Funding: This study received funds from the National Fund for Science and Technology (FONCI-CITMA-Cuba, contract 2020-20) of the Ministry of Science, Technology and Environment of Cuba.

Reunión al egreso o sesión de alta: vínculo entre asistencia y docencia / Meeting at discharge or discharging session: link between assistance and teaching

Con motivo de considerarse la reunión al egreso o sesión de alta como un elemento que sella la emisión del diagnóstico del paciente, así como resume su tratamiento, orienta su seguimiento por consulta externa o por la atención primaria y se establece el momento para conocer del grado de satisfacción del paciente y sus familiares, cuestión que resulta un indicador de la calidad de la asistencia médica; valoramos necesario emitir recomendaciones acerca de la necesidad de la ejecución de la sesión de alta a partir del análisis de la literatura consultada y de la experiencia empírica obtenida. Conociendo por parte de los educandos que esta habilidad compete a la educación en el trabajo, en área práctica y tiene sus desencuentros en nuestra realidad pensamos necesario tomarla en consideración(AU)

As a result of considering the meeting at discharge or discharging session an element closing the emission of the patients diagnosis, and also reviewing his/her treatment, where the follow-up in external consultation or in the primary health care level is oriented, and arrives the time of knowing the satisfaction level of the patient and his/her relatives (an indicator of the medical care quality), we decided to emit recommendations about the necessity of carrying out the discharging session, on the bases of the analysis of the reviewed literature and the accumulated empiric experience. We thought that it is necessary to take into account this skill, knowing for the students that it depends on education at work, in the area of the practice, and shows problems in our surroundings(AU)

Vigilancia antipalúdica en Camagüey, Cuba. 1986-2011 / Antipaludic surveillance in Camagüey, Cuba. 1986-2011

Se realizó un estudio descriptivo, longitudinal y retrospectivo mediante revisión documental del libro de registro de muestras, del Laboratorio Provincial de Parasitología del Centro Provincial de Higiene, Epidemiología y Microbiología de Camagüey (Cuba) para mostrar los resultados de 25 años de vigilancia antipalúdica, relacionados con algunas variables de importancia epidemiológica durante el período 1986-2011. Se consideró el mes de arribo, país de procedencia, sexo, especie de Plasmodium diagnosticada, grado de parasitemia, municipio de residencia en Cuba, lugar de ejecución y verificación del diagnóstico, así como el nivel de concordancia con los laboratorios de referencia provincial y nacional. Se confeccionó una base de datos con el total de casos diagnosticados, para determinar la frecuencia absoluta y relativa de casos. Se utilizó el software estadístico profesional SPSS. Un total de 253 viajeros resultaron positivos siendo el 94.5% hombres provenientes de Angola (88.88%) con predominio de P. falciparum (62.0%). Se diagnosticaron además recaídas y recrudescencias

A descriptive, longitudinal and retrospective study was make in Camaguey with patients to come from endemic areas of Malaria, during 1986 to 2011. Some of them, illness with malaria in Camaguey after to arrive. The results’s presentation was an important topic for the authors because that a background of 25 years of surveillance in our province and also to establish relation between some epidemiological variable. 253 traveller were diagnostic with Malaria, 94.5% were male, 88.8% come from Angola and Plasmodium falciparum was the predominant specie with 61.30%. The parasitemie grade more frequent were two and tree plus but (trophozoites) rings, schizonts and gametocytes form of P.vivax and gametocytes of P. falciparum were detected too. An important number of recurrent malaria was diagnostic during the surveillance period. The majority of the laboratory in the province did malaria diagnosis; the slides were verificate in the Provincial Microbiology Reference Laboratory

The observed vs. expected lung-to-head ratio does not correct for the effect of gestational age on the lung-to-head ratio.

OBJECTIVES: To assess whether the observed vs. expected lung-to-head ratio (o/e LHR) corrects for the dependence of the LHR on gestational age. STUDY DESIGN: Published data on right lung area (LA) and LHR were used to plot the 50th percentile and different fixed values of the o/e LHR (e.g. 30%) against gestational age from 16-32 weeks. The Z-scores for various fixed o/e LHR values and similar percent value of LA were calculated. The effect of using a fixed LHR or a fixed o/e LHR was tested against gestational age. The o/e LHR-equivalent to a fixed LHR of 1.0 was assessed against gestational age. RESULTS: The LHR and the o/e LHR both increase with gestational age. The Z-score of a given fixed value of the o/e LHR (e.g. 30%) is not similar to the Z-score of the same percent (e.g., 30%) of the expected LA, and thus identifies different proportions of subjects. A fixed o/e LHR (e.g. 30%) results in different populations, depending on the gestational age. The o/e LHR equivalent to an LHR value of 1.0 decreases from 80% at 16 weeks to 30% at 32 weeks. CONCLUSIONS: The o/e LHR is not independent of gestational age. Studies using this parameter should be interpreted with caution.

Aqueous extract of Ocimum tenuiflorum decreases levels of blood glucose in induced hyperglycemic tilapia (Oreochromis niloticus).

OBJECTIVE: To evaluate, in hyperglycemic tilapia [Oreochromis niloticus (O. niloticus)], the effect of this aqueous extract on blood glucose levels. METHODS: The hyperglycemia in O. niloticus was induced by adding glucose to fish pond water. An aqueous extract of Ocimum tenuiflorum (O. tenuiflorum) was prepared by boiling fresh leaves and the doses of 0, 40, 80, 200 and 400 mg per liter of pond water were tested. RESULTS: The blood sugar concentration for tilapia with hyperglycemic induced was an average of 50% higher than the control group. The blood glucose levels in tilapia after the induction of hyperglycemia were higher than the control group for 90 min after the treatment. The treatment with the aqueous extract of O. tenuiflorum dropped the serum glucose level of hyperglycemic tilapia until it was similar to that of the control group and was dose dependent. CONCLUSIONS: The results indicated that O. tenuiflorum was endowed with anti-hyperglycemic activity. To our knowledge, this is the first report on the use of fish as a diabetes model to test natural extracts from plants.

Miositis osificante postraumática / Postraumatic myositis ossificans

La miositis osificante circunscrita postraumática es un proceso proliferativo, benigno, en el que ocurre formación metaplásica de hueso en un tejido no óseo. Se realizó la presentación de un caso con diagnóstico de miositis osificante en la región de la cadera, como complicación de un desgarro muscular. Se realizó una revisión actualizada del tema y de los métodos de diagnóstico de esta afección(AU)

Postraumatic circumscriptus myositis ossificans is a proliferative benign process in which metaplastic formation occurs in non-osseous tissue. A case diagnosed with myositis ossificans in the hip as a complication of a muscular tear was presented. An updated literature review on this topic and the corresponding diagnosing methods was made(AU)

Miositis osificante postraumática / Myosite ossifiante post-traumatique / Postraumatic myositis ossificans

La miositis osificante circunscrita postraumßtica es un proceso proliferativo, benigno, en el que ocurre formación metaplásica de hueso en un tejido no óseo. Se realizó la presentación de un caso con diagnóstico de miositis osificante en la región de la cadera, como complicación de un desgarro muscular. Se realizó una revisión actualizada del tema y de los métodos de diagnóstico de esta afección.

Postraumatic circumscriptus myositis ossificans is a proliferative benign process in which metaplastic formation occurs in non-osseous tissue. A case diagnosed with myositis ossificans in the hip as a complication of a muscular tear was presented. An updated literature review on this topic and the corresponding diagnosing methods was made.

La myosite ossifiante localisée post-traumatique est un processus prolifératif bénin, caractérisé par la métaplasie d'un tissu non-osseux en tissu osseux. La présentation d'un cas diagnostiqué de myosite ossifiante au niveau de la hanche, secondaire à une déchirure musculaire, est réalisée. Une revue actualisée sur cette anomalie, notamment les méthodes diagnostiques de cette condition, a été réalisée.

Utilidad del Exudado Vaginal en el pesquisaje de Infecciones de Transmisión Sexual / The value of vaginal exudation in the search for sexually transmitted infections

El exudado vaginal es un método fácil y confiable para el diagnóstico de Infecciones de transmisión sexual (ITS). Puede ayudar en el diagnóstico de infecciones como Vaginosis Bacteriana, Candidiasis, Trichomoniasis y Cervicitis, sin embargo, el nivel de entrenamiento y experiencia del individuo que lo realiza es extremadamente importante para obtener buenos resultados(AU)

[Human immunodeficiency virus infection in pregnant women. The importance of recognizing the infection during pregnancy and risk factors for perinatal transmission]. / Infección por virus de inmunodeficiencia humana en la embarazada. Importancia del conocimiento de la infección en el embarazo y factores de riesgo en la transmisión perinatal.

BACKGROUND: Using adequate infection control measures, the rate of vertical transmission of human immunodeficiency virus (HIV) during pregnancy, has been reduced to 3% in Chile. AIM: To determine vertical transmission rate and risk factors associated to perinatal infection in pregnant women with known (KI) and unknown HIV infection (UI). PATIENTS AND METHODS: HIV infected pregnant women whose deliveries were attended at the San Borja Arriaran Hospital were included. Antiretroviral therapy (ART) has been used since 1995 (Zidovudine 13 patients, biOtherapy 4 and triple therapy 14 patients). Newborns have received ART since 1995. Premature labor without evident cause, premature rupture of membranes, and rupture of membranes over 4 h before delivery were evaluated. Delivery was by elective cesarean section since 1993. Breast feeding was avoided. Pregnant women with UI (suspected disease after delivery due to child or mother pathology) did not received ART. Delivery and breast feeding were managed with common obstetrical-neonatal criteria. RESULTS: Fifty three HIV infected pregnant women were studied (43 with KI and 10 with UI). Four children (36.4%) from the KI group and seven (63.6%) from the UI group became infected. The global rate of vertical transmission among KI group was significantly lower than UI group: 9.5% (4/42) vs 70.0% (7/10) p < 0.001. Using ART, this rate was further reduced to 6.5% (2/31) and with bitherapy or triple therapy to 0% (0/18). Breast feeding, vaginal delivery, premature delivery with no clinical cause, premature rupture of membranes, rupture of membranes longer than 4 h and lack of ART, were significantly more common in the UI group, compared with KI group. CONCLUSIONS: Vertical transmission in pregnant women with KI is significantly lower compared with UI. Risk factors increasing HIV perinatal infection are: breast feeding, lack of ART, vaginal delivery, premature rupture of membranes, rupture of membranes > 4 h and premature labor without a clinical cause.