Safety and Immunogenicity of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Subgroup of Healthy Adults in Chile

Journal
Clinical Infectious Diseases
ISSN
1058-4838
1537-6591
Date Issued
2021
Author(s)
Susan M Bueno
Katia Abarca
GONZALEZ, PABLO
Nicolás M S Gálvez
Jorge A Soto
Luisa F Duarte
Bárbara M Schultz
Gaspar A Pacheco
Liliana A González
Yaneisi Vázquez
Mariana Ríos
Felipe Melo-González
Daniela Rivera-Pérez
Carolina Iturriaga
Marcela Urzúa
Angélica Domínguez
Catalina A Andrade
Roslye V Berríos-Rojas
Gisela Canedo-Marroquín
Camila Covián
Daniela Moreno-Tapia
Farides Saavedra
Omar P Vallejos
Paulina Donato
Pilar Espinoza
Daniela Fuentes
Marcela González
Paula Guzmán
Carlos M Pérez
Marcela Potin
Álvaro Rojas
Rodrigo A Fasce
Jorge Fernández
Judith Mora
Eugenio Ramírez
Aracelly Gaete-Argel
Aarón Oyarzún-Arrau
Fernando Valiente-Echeverría
Ricardo Soto-Rifo
Daniela Weiskopf
Alessandro Sette
Gang Zeng
Weining Meng
José V González-Aramundiz
Alexis M Kalergis
Type
Resource Types::text::journal::journal article
Scopus ID
2-s2.0-85137127483
WoS ID
WOS:000756599900001
DOI
URL
URL Institutional Repository
Abstract
<jats:title>Abstract</jats:title>
<jats:sec>
<jats:title>Background</jats:title>
<jats:p>The development of effective vaccines against coronavirus disease 2019 is a global priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine with promising safety and immunogenicity profiles. This article reports safety and immunogenicity results obtained for healthy Chilean adults aged ≥18 years in a phase 3 clinical trial.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods</jats:title>
<jats:p>Volunteers randomly received 2 doses of CoronaVac or placebo, separated by 2 weeks. A total of 434 volunteers were enrolled, 397 aged 18–59 years and 37 aged ≥60 years. Solicited and unsolicited adverse reactions were registered from all volunteers. Blood samples were obtained from a subset of volunteers and analyzed for humoral and cellular measures of immunogenicity.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Results</jats:title>
<jats:p>The primary adverse reaction in the 434 volunteers was pain at the injection site, with a higher incidence in the vaccine than in the placebo arm. Adverse reactions observed were mostly mild and local. No severe adverse events were reported. The humoral evaluation was performed on 81 volunteers. Seroconversion rates for specific anti-S1-receptor binding domain (RBD) immunoglobulin G (IgG) were 82.22% and 84.44% in the 18–59 year age group and 62.69% and 70.37% in the ≥60 year age group, 2 and 4 weeks after the second dose, respectively. A significant increase in circulating neutralizing antibodies was detected 2 and 4 weeks after the second dose. The cellular evaluation was performed on 47 volunteers. We detected a significant induction of T-cell responses characterized by the secretion of interferon-γ (IFN-γ) upon stimulation with Mega Pools of peptides from SARS-CoV-2.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusions</jats:title>
<jats:p>Immunization with CoronaVac in a 0–14 schedule in Chilean adults aged ≥18 years is safe, induces anti-S1-RBD IgG with neutralizing capacity, activates T cells, and promotes the secretion of IFN-γ upon stimulation with SARS-CoV-2 antigens.</jats:p>
</jats:sec>
Cite this document
Bueno, S. M., Abarca, K., González, P. A., Gálvez, N. M. S., Soto, J. A., Duarte, L. F., Schultz, B. M., Pacheco, G. A., González, L. A., Vázquez, Y., Ríos, M., Melo-González, F., Rivera-Pérez, D., Iturriaga, C., Urzúa, M., Domínguez, A., Andrade, C. A., Berríos-Rojas, R. V., Canedo-Marroquín, G., … Kalergis, A. M. (2022). Safety and immunogenicity of an inactivated severe acute respiratory syndrome coronavirus 2 vaccine in a subgroup of healthy adults in chile. Clinical Infectious Diseases, 75(1), e792-e804. https://doi.org/10.1093/cid/ciab823
Subjects
coronavac

; 

phase 3 clinical trial

; 

sars-cov-2

; 

covid-19

; 

vaccines

; 

adolescent

; 

adult

; 

antibodies, neutralizing

; 

antibodies, viral

; 

chile

; 

covid-19

; 

covid-19 vaccines

; 

double-blind method

; 

humans

; 

immunogenicity, vaccine

; 

immunoglobulin g

; 

middle aged

; 

sars-cov-2

; 

vaccines, inactivated

; 

viral vaccines

; 

young adult

; 

cd8alpha antigen

; 

coronavac

; 

gamma interferon

; 

immunoglobulin g antibody

; 

neutralizing antibody

; 

placebo

; 

s1 receptor binding domain antibody

; 

sars-cov-2 antibody

; 

unclassified drug

; 

immunoglobulin g

; 

inactivated vaccine

; 

neutralizing antibody

; 

virus antibody

; 

virus vaccine

; 

adult

; 

anorexia

; 

arthralgia

; 

article

; 

cd8+ t lymphocyte

; 

cellular immunity

; 

chile

; 

controlled study

; 

coronavirus disease 2019

; 

cytokine release

; 

diarrhea

; 

drug hypersensitivity

; 

drug safety

; 

enzyme linked immunosorbent assay

; 

enzyme linked immunospot assay

; 

erythema

; 

fatigue

; 

female

; 

fever

; 

flow cytometry

; 

headache

; 

human

; 

human experiment

; 

humoral immunity

; 

injection site pain

; 

male

; 

middle aged

; 

myalgia

; 

nausea

; 

normal human

; 

peripheral blood mononuclear cell

; 

phase 3 clinical trial

; 

pruritus

; 

rash

; 

seroconversion

; 

surrogate virus neutralization test

; 

swelling

; 

t lymphocyte

; 

vaccine immunogenicity

; 

virus neutralization

; 

virus neutralization test

; 

vomiting

; 

adolescent

; 

adverse event

; 

chile

; 

double blind procedure

; 

prevention and control

; 

vaccine immunogenicity

; 

young adult