Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
Journal
Vaccines
ISSN
2076-393X
Date Issued
2022
Author(s)
Katia Abarca
Carolina Iturriaga
Marcela Urzúa
Nicole Le Corre
Augusto Pineda
Carolina Fernández
Angélica Domínguez
Pablo González
Susan M. Bueno
Paulina Donato
Pilar Espinoza
Daniela Fuentes
Marcela González
Paula Guzmán
Carlos M. Pérez
Marcela Potin
Álvaro Rojas
José V. González-Aramundiz
Nicolás M. S. Gálvez
Francisca Aguirre-Boza
Sofía Aljaro
Luis Federico Bátiz
Yessica Campisto
Mariela Cepeda
Aarón Cortés
Sofía López
María Loreto Pérez
Alexis M. Kalergis
Type
Resource Types::text::journal::journal article
URL Institutional Repository
Abstract
<jats:p>Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.</jats:p>
Cite this document
Abarca, K., Iturriaga, C., Urzúa, M., Le Corre, N., Pineda, A., Fernández, C., Domínguez, A., González, P. A., Bueno, S. M., Donato, P., Espinoza, P., Fuentes, D., González, M., Guzmán, P., Muñoz-Venturelli, P., Pérez, C. M., Potin, M., Rojas, Á., González-Aramundiz, J. V., … on behalf of the CoronaVac03CL Study Group. (2022). Safety and non-inferiority evaluation of two immunization schedules with an inactivated sars-cov-2 vaccine in adults: A randomized clinical trial. Vaccines, 10(7), 1082. https://doi.org/10.3390/vaccines10071082
Subjects
coronavac®
;
covid-19
;
immunization schedules
;
phase iii clinical trial
;
sars-cov-2
;
vaccines
;
coronavac
;
adult
;
aged
;
allergy
;
anorexia
;
arthralgia
;
article
;
controlled study
;
coronavirus disease 2019
;
diarrhea
;
disease severity
;
drug efficacy
;
drug safety
;
fatigue
;
female
;
fever
;
headache
;
hospitalization
;
human
;
immunization
;
incidence
;
injection site induration
;
intensive care unit
;
major clinical study
;
male
;
multicenter study
;
myalgia
;
nasopharyngeal swab
;
nausea
;
pain
;
pruritus
;
randomized controlled trial
;
rash
;
real time reverse transcription polymerase chain reaction
;
skin redness
;
swelling
;
vaccination
;
vomiting