Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial.

BACKGROUND: The Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial. METHODS: This double-blind, randomised, international, placebo-controlled, endpoint-case driven, phase 3, clinical trial enrolled adults aged 18 years older at study centres in Argentina, Chile, Mexico, Pakistan, and Russia. Participants were eligible for the study if they had no unstable or severe underlying medical or psychiatric conditions; had no history of a laboratory-confirmed SARS-CoV-2 infection; were not pregnant or breastfeeding; and had no previous receipt of an adenovirus-vectored, coronavirus, or SARS-CoV-2 vaccine. After informed consent was obtained, 25 mL of whole blood was withdrawn from all eligible participants who were randomised in a 1:1 ratio to receive a single intramuscular dose of 0·5 mL placebo or a 0·5 mL dose of 5 × 1010 viral particle (vp)/mL Ad5-nCoV vaccine; study staff and participants were blinded to treatment allocation. All participants were contacted weekly by email, telephone, or text message to self-report any symptoms of COVID-19 illness, and laboratory testing for SARS-CoV-2 was done for all participants with any symptoms. The primary efficacy objective evaluated Ad5-nCoV in preventing symptomatic, PCR-confirmed COVID-19 infection occurring at least 28 days after vaccination in all participants who were at least 28 days postvaccination on Jan 15, 2021. The primary safety objective evaluated the incidence of any serious adverse events or medically attended adverse events postvaccination in all participants who received a study injection. This trial is closed for enrolment and is registered with ClinicalTrials.gov (NCT04526990). FINDINGS: Study enrolment began on Sept 22, 2020, in Pakistan, Nov 6, 2020, in Mexico, Dec 2, 2020, in Russia and Chile, and Dec 17, 2020, in Argentina; 150 endpoint cases were reached on Jan 15, 2021, triggering the final primary efficacy analysis. One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7-70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination (21 250 participants; 45 days median duration of follow-up [IQR 36-58]). In the primary safety analysis undertaken at the time of the efficacy analysis (36 717 participants), there was no significant difference in the incidence of serious adverse events (14 [0·1%] of 18 363 Ad5-nCoV recipients and 10 [0·1%] of 18 354 placebo recipients, p=0·54) or medically attended adverse events (442 [2·4%] of 18 363 Ad5-nCoV recipients and 411 [2·2%] of 18 354 placebo recipients, p=0·30) between the Ad5-nCoV or placebo groups, or any serious adverse events considered related to the study product (none in both Ad5-nCoV and placebo recipients). In the extended safety cohort, 1004 (63·5%) of 1582 of Ad5-nCoV recipients and 729 (46·4%) of 1572 placebo recipients reported a solicited systemic adverse event (p<0·0001), of which headache was the most common (699 [44%] of Ad5-nCoV recipients and 481 [30·6%] of placebo recipients; p<0·0001). 971 (61·3%) of 1584 Ad5-nCoV recipients and 314 (20·0%) of 1573 placebo recipients reported an injection-site adverse event (p<0·0001), of which pain at the injection site was the most frequent; reported by 939 (59%) Ad5-nCoV recipients and 303 (19%) placebo recipients. INTERPRETATION: One dose of Ad5-nCoV is efficacious and safe in healthy adults aged 18 years and older. FUNDING: CanSino Biologics and the Beijing Institute of Biotechnology.

The relationship among mental health status (GHQ-12), health related quality of life (EQ-5D) and health-state utilities in a general population.

AIM: To assess the relationship between mental health and health-related quality of life (HRQL) in the general population, and to map GHQ-12 as a screening test for population psychological distress to a generic health state measure (EQ-5D) in order to estimate health state values and allow deriving quality-adjusted life years. METHODS: Relationship between mental health and HRQL was examined from the 2004 Canary Islands' Health Survey. Participants were classified as probable psychiatric cases according to GHQ-12. HRQL was measured by the EQ-5D index. Multivariate lineal regression analysis was used to examine the association between mental health and HRQL adjusting by socio-demographic variables and comorbidities. A multivariate regression model was built from EQ-5D to estimate health states values using GHQ-12 as exposure. RESULTS: EQ-5D index scores decreased as the GHQ-12 scores increased. Clinical and socio-demographic factors influenced HRQL without changing the overall trend for this negative relationship. The regression equation explained 43% of the variance. For estimation of utility scores, the model showed a high predictive capacity, with a mean forecast errors of 16%. CONCLUSIONS: HRQL progressively decreased when the probability of being a psychiatric case increased. Findings enable health state values to be derived from GHQ-12 scores for populations where utilities has not or cannot be measured directly.

Appropiate use of blood products in pediatric patients in a Venezuelan General University Hospital: cross-sectional study

La transfusión es una tecnología asociada con un elevado costo económico; es necesario para garantizar su seguridad para reducir el riesgo de enfermedades asociadas con la transfusión. No existen estudios que hayan evaluado el uso apropiado de los componentes sanguíneos en población pediátrica. El objetivo fue determinar la prevalencia del uso apropiado de componentes sanguíneos en pediatría. Utilizando los criterios de Asociación Americana de Bancos de Sangre, se realizó un estudio de corte transversal, en la Ciudad Hospitalaria "Dr. Enrique Tejera", principal hospital universitario de Valencia, Venezuela. Se estudiaron pacientes (n=404) hospitalizados en los servicios de medicina, cirugía, emergencia, recién nacidos enfermos, retén de prematuros y cuidados intensivos. El principal desenlace evaluado fue el uso apropiado de la sangre total y de los componentes sanguíneos. La prevalencia (PV) global del uso apropiado fue 60,49 por ciento; por Departamentos fue 87,8 por ciento en Medicina, 47,4 por ciento en Cirugía, 65 por ciento en Emergencia, 55,4 por ciento en Recién Nacidos Patológicos, 44 por ciento en Retén de Prematuros, 51,1 por ciento Retén de Recién Nacidos y 81,3 por ciento en Unidad de Cuidados Intensivos. La PV del uso apropiado por hemoderivado fue 76 por ciento para concentrado de glóbulos rojos, 83 por ciento para sangre total, 52,6 por ciento para plaquetas, 38,3 por ciento para plasma fresco congelado y 28,6 por ciento para crioprecipitado. Las principales conclusiones del estudio son: 1) La prevalencia del uso apropiado de los componentes fue de 60,9 por ciento, 2) Existe alto riesgo de uso inapropiado de concentrado de plaquetas, plasma fresco congelado y crioprecipitado y 3) Los servicios de Medicina y Cuidados Intensivos poseen alta prevalencia (>80 por ciento) de uso apropiado de transfusiones