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...
Aortopulmonary window may rarely present in adulthood. The diagnosis can usually be made by careful echocardiography alone. Even in the presence of severe pulmonary arterial hypertension, if a significant reversibility in pulmonary vascular resistance can be demonstrated with oxygen, the condition can be successfully corrected with good long-term outcomes.
Background
Sinus of valsalva aneurysm (SVA) with rupture is a rare cardiac anomaly which can be congenital or acquired with reported incidence of 0.46%–3.57% among Asians population.
Aim of the Study
The aim of this study is to analyze 30 years of single institutional surgical experience in management of 216 cases with SVAs from 1992 till date.
Methods
Age group was from 6 to 64 years (mean: 32.5 ± 11 years) with male to female ratio of 2.2:1. The aneurysms originated from right coronary sinus in 181 cases (83.79%), noncoronary sinus in 35 cases (15.74%) and ruptured into the right ventricle in 149 cases (68.98%), right atrium in 59 cases (27.31%). Bicameral approach was used in majority of the cases (n = 213, 98.61%). Aneurysms were repaired using Dacron patch in 173 cases (80.09%) and direct closure in 43 cases (19.9%). Associated ventricular septal defect was closed with Dacron patch in 123 cases (56.94%). Aortic valve was replaced in 21 cases (9.72%) and aortic valve repair was performed in 14 cases (6.48%) for associated Aortic regurgitation.
Results
There were no perioperative hospital deaths. Follow‐up was available in 204 patients (94.44%) ranging from 2 to 26 years (mean: 10 ± 5.6 years). Two deaths (0.92%) occurred during the postoperative follow‐up period. The actual survival was 99.5% at 1 year, 99% at 5 and 10 years.
Conclusion
Long term results of surgically repaired SVAs are good with low morbidity (3.24%) and mortality (0.92%) even when associated with major cardiac anomalies. Aortic valve repair and replacement both are equally feasible alternatives for management of moderate to severe aortic regurgitation with associated merits and demerits.
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