Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...
Several COVID-19 vaccines have shown good efficacy in clinical trials, but there remains uncertainty about the efficacy of vaccines against different variants. Here, we investigate the efficacy of ChAdOx1 nCoV-19 (AZD1222) against symptomatic COVID-19 in a post-hoc exploratory analysis of a Phase 3 randomised trial in Brazil (trial registration ISRCTN89951424). Nose and throat swabs were tested by PCR in symptomatic participants. Sequencing and genotyping of swabs were performed to determine the lineages of SARS-CoV-2 circulating during the study. Protection against any symptomatic COVID-19 caused by the Zeta (P.2) variant was assessed in 153 cases with vaccine efficacy (VE) of 69% (95% CI 55, 78). 49 cases of B.1.1.28 occurred and VE was 73% (46, 86). The Gamma (P.1) variant arose later in the trial and fewer cases (N = 18) were available for analysis. VE was 64% (−2, 87). ChAdOx1 nCoV-19 provided 95% protection (95% CI 61%, 99%) against hospitalisation due to COVID-19. In summary, we report that ChAdOx1 nCoV-19 protects against emerging variants in Brazil despite the presence of the spike protein mutation E484K.
Objective: To assess quality of life, prevalence of depressive and minor psychiatric symptoms in Nursing students. Methods: Cross-sectional study, conducted from March to April 2018, at a federal university. Sample composed of 242 Nursing students, from the 1st to the 8th semester. Data was collected using the quality of life instruments, Beck Depression Inventory and Self-Report Questionnaire. A significance level of 0.05 was considered. Results: The mean age was 22.9 ± 5.1 years. It was found that 25% of the students had severe depressive symptoms and 54% of the students had minor psychiatric disorders, with a higher prevalence in the first semesters. An inverse relationship was observed between the frequency of depressive symptoms and quality of life scores (p = 0.05). Conclusion: Nursing students showed a high prevalence of depressive symptoms, indicating the importance of implementing actions to promote and prevent mental health.
Objective: to analyze evidence concerning the risks of occupational illnesses to which health workers providing care to patients infected with COVID-19 are exposed. Method: integrative literature review conducted in the following online databases: Medical Literature Analysis and Retrieval System Online (MEDLINE/PubMed), Web of Science (WoS), Excerpta Medica Data-Base (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Scopus (Elsevier). Original articles published between November 2019 and June 2020, regardless of the language written, were included. A descriptive analysis according to two categories is presented. Results: the sample is composed of 19 scientific papers. Most were cross-sectional studies with an evidence level 2C (n=17, 90%) written in English (n=16, 84%). The primary thematic axes were risk of contamination and risk of psycho-emotional illness arising from the delivery of care to patients infected with COVID-19. Conclusion: the review presents the potential effects of providing care to patients with COVID-19 on the health of workers. It also reveals the importance of interventions focused on the most prevalent occupational risks during the pandemic. The studies’ level of evidence suggests a need for studies with more robust designs.
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