ABSTRACT
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.
ABSTRACT
Se realizó un estudio cuasiexperimental de intervención educativa para intervenir en el nivel de conocimientos que sobre Diabetes Mellitus tienen los adultos mayores del consultorio médico # 6 de la Policlínica Universitaria Francisca Rivero Arocha de Manzanillo entre abril de 2008 y enero del 2010. Se empleó un muestreo no probabilístico al azar aplicando los criterios de inclusión, lo que determinó una muestra de 50 ancianos diabéticos. Se utilizó la encuesta, como fuente primaria de recolección de datos, para determinar las necesidades de aprendizaje. La prueba de los signos constituyó la medida estadística utilizada. Predominó el consumidor de café sin práctica de ejercicios físicos, no cumplían con la dieta establecida y consumían regularmente sus medicamentos. Al inicio del estudio, losgerontes tuvieron un conocimiento inadecuado sobre la diabetes mellitus, que se elevó después de la intervención.(AU)
A quasiexperimental study of educative intervention was carried out to increase the knowledge of elderly patients concerning Diabetes Mellitus in the Doctor´s office #6, from Fransisca Rivero Aroche Polyclinic, since April 2008 to January 2010. A non probabilistic sample was taken at random, which made a total of 50 patients suffering from Diabetes. Also, as a primary source of information, it was used the survey, to determine the learning needs of the sampling. The Signs test constituted the statistical measure applied. The greater incidence was related to coffee drinkers who did not practice physical exercises or did not have a healthy diet regime, taking regularly their medication. At the beginning of the research, the elderly patients did not have an adequate knowledge about the disease, what increased with the application of the intervention project.(EU)
