학술논문

Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine
Document Type
article
Source
New England Journal of Medicine. 385(25)
Subject
Clinical Trials and Supportive Activities
Lung
Patient Safety
Vaccine Related
Prevention
Immunization
Clinical Research
Infectious Diseases
Emerging Infectious Diseases
6.1 Pharmaceuticals
Evaluation of treatments and therapeutic interventions
Good Health and Well Being
Adolescent
Adult
Aged
Aged
80 and over
Antibodies
Neutralizing
Antibodies
Viral
COVID-19
ChAdOx1 nCoV-19
Chile
Double-Blind Method
Female
Humans
Immunogenicity
Vaccine
Male
Middle Aged
Peru
SARS-CoV-2
Spike Glycoprotein
Coronavirus
United States
Vaccine Efficacy
Young Adult
AstraZeneca AZD1222 Clinical Study Group
Medical and Health Sciences
General & Internal Medicine
Language
Abstract
BackgroundThe safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.MethodsIn this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru.ResultsA total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P