Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial

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dc.catalogadorvzp
dc.contributor.authorAbarca Villaseca, Katia
dc.contributor.authorIturriaga Ortiz, Carolina Alejandra
dc.contributor.authorUrzua, Marcela
dc.contributor.authorLe Corre Perez, Monique Nicole
dc.contributor.authorPineda Núñez, Augusto Naim
dc.contributor.authorFernandez Anwandter, Carolina
dc.contributor.authorDomínguez De Landa, María Angelica
dc.contributor.authorGonzález Carbonell, Pablo Andrés
dc.contributor.authorBueno, Susan M.
dc.contributor.authorDonato, Paulina
dc.contributor.authorEspinoza, Pilar
dc.contributor.authorFuentes, Daniela
dc.contributor.authorGonzalez, Marcela
dc.contributor.authorGuzman, Paula
dc.contributor.authorMunoz-Venturelli, Paula
dc.contributor.authorPerez, Carlos M.
dc.contributor.authorPotin, Marcela
dc.contributor.authorRojas, Alvaro
dc.contributor.authorGonzalez-Aramundiz, Jose, V
dc.contributor.authorGalvez, Nicolas M. S.
dc.contributor.authorAguirre-Boza, Francisca
dc.contributor.authorAljaro, Sofia
dc.contributor.authorFederico Batiz, Luis
dc.contributor.authorCampisto, Yessica
dc.contributor.authorCepeda, Mariela
dc.contributor.authorCortes, Aaron
dc.contributor.authorLopez, Sofia
dc.contributor.authorLoreto Perez, Maria
dc.contributor.authorSchilling, Andrea
dc.contributor.authorKalergis, Alexis M.
dc.date.accessioned2024-01-30T19:16:17Z
dc.date.available2024-01-30T19:16:17Z
dc.date.issued2022
dc.description.abstractSeveral vaccines have been developed to control the COVID-19 pandemic. CoronaVac (R), 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 (R) 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 (R) is safe, especially in >= 60-year-old participants. Both schedules protected against COVID-19 hospitalization.
dc.fechaingreso.objetodigital2024-05-30
dc.format.extent14 páginas
dc.fuente.origenWOS
dc.identifier.doi10.3390/vaccines10071082
dc.identifier.eissn2076-393X
dc.identifier.urihttp://doi.org/10.3390/vaccines10071082
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/81077
dc.identifier.wosidWOS:000831401400001
dc.information.autorucEscuela de Medicina; Abarca Villaseca Katia; 0000-0003-0404-3887; 70281
dc.information.autorucEscuela de Medicina; Iturriaga Ortiz Carolina Alejandra; ; 1058623
dc.information.autorucEscuela de Medicina; Le Corre Perez Monique Nicole; 0000-0002-9361-4049; 6737
dc.information.autorucEscuela de Medicina; Pineda Nuñez Augusto Naim; ; 215835
dc.information.autorucEscuela de Medicina; Fernandez Anwandter Carolina; ; 1003209
dc.information.autorucEscuela de Medicina; Dominguez De Landa Maria Angelica; 0000-0001-7477-7574; 131798
dc.information.autorucEscuela de Medicina; Gonzalez Carbonell Pablo Andres; ; 141647
dc.issue.numero7
dc.language.isoen
dc.nota.accesoContenido completo
dc.pagina.final14
dc.pagina.inicio1
dc.publisherMDPI
dc.revistaVACCINES
dc.rightsacceso abierto
dc.rights.licenseCreative Commons Attribution-NonCommercial License (BY-NC-4.0)
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.subjectCoronaVac (R)
dc.subjectPhase III clinical trial
dc.subjectSARS-CoV-2
dc.subjectCOVID-19
dc.subjectVaccines
dc.subjectImmunization schedules
dc.subject.ddc610
dc.subject.deweyMedicina y salud
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleSafety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
dc.typeartículo
dc.volumen10
sipa.codpersvinculados70281
sipa.codpersvinculados1058623
sipa.codpersvinculados6737
sipa.codpersvinculados215835
sipa.codpersvinculados1003209
sipa.codpersvinculados131798
sipa.codpersvinculados141647
sipa.trazabilidadWOS;2022-10-11
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