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

Katia Abarca; Carolina Iturriaga; Marcela Urzúa; Nicole Le Corre; Augusto Pineda; Carolina Fernández; Angélica Domínguez; Pablo A. González; Susan M. Bueno; Paulina Donato; Pilar Espinoza; Daniela Fuentes; Marcela González; Paula Guzmán; Paula Muñoz Venturelli; Carlos M. Potin; 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; Andrea Schilling; Alexis M. Kalergis

doi:10.3390/vaccines10071082

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

Katia Abarca^*, Carolina Iturriaga, Marcela Urzúa, Nicole Le Corre, Augusto Pineda, Carolina Fernández, Angélica Domínguez, Pablo A. González, Susan M. Bueno, Paulina Donato, Pilar Espinoza, Daniela Fuentes, Marcela González, Paula Guzmán, Paula Muñoz Venturelli, Carlos M. Potin, Marcela Potin, Álvaro Rojas, José V. González-Aramundiz, Nicolás M.S. GálvezFrancisca Aguirre-Boza, Sofía Aljaro, Luis Federico Bátiz, Yessica Campisto, Mariela Cepeda, Aarón Cortés, Sofía López, María Loreto Pérez, Andrea Schilling, Alexis M. Kalergis^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

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.

Original language	English
Article number	1082
Journal	Vaccines
Volume	10
Issue number	7
DOIs	https://doi.org/10.3390/vaccines10071082
State	Published - 6 Jul 2022

Bibliographical note

Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.

Keywords

COVID-19
CoronaVac®
SARS-CoV-2
immunization schedules
phase III clinical trial
vaccines

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10.3390/vaccines10071082

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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., Venturelli, P. M., Potin, C. M., Potin, M., Rojas, Á., González-Aramundiz, J. V., ... Kalergis, A. M. (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), Article 1082. https://doi.org/10.3390/vaccines10071082

@article{0e709ae144a644b89f86ffdea3709422,

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

abstract = "Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac{\textregistered}, 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{\textregistered} 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{\textregistered} is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.",

keywords = "COVID-19, CoronaVac{\textregistered}, SARS-CoV-2, immunization schedules, phase III clinical trial, vaccines",

author = "Katia Abarca and Carolina Iturriaga and Marcela Urz{\'u}a and {Le Corre}, Nicole and Augusto Pineda and Carolina Fern{\'a}ndez and Ang{\'e}lica Dom{\'i}nguez and Gonz{\'a}lez, {Pablo A.} and Bueno, {Susan M.} and Paulina Donato and Pilar Espinoza and Daniela Fuentes and Marcela Gonz{\'a}lez and Paula Guzm{\'a}n and Venturelli, {Paula Mu{\~n}oz} and Potin, {Carlos M.} and Marcela Potin and {\'A}lvaro Rojas and Gonz{\'a}lez-Aramundiz, {Jos{\'e} V.} and G{\'a}lvez, {Nicol{\'a}s M.S.} and Francisca Aguirre-Boza and Sof{\'i}a Aljaro and B{\'a}tiz, {Luis Federico} and Yessica Campisto and Mariela Cepeda and Aar{\'o}n Cort{\'e}s and Sof{\'i}a L{\'o}pez and P{\'e}rez, {Mar{\'i}a Loreto} and Andrea Schilling and Kalergis, {Alexis M.}",

note = "Publisher Copyright: {\textcopyright} 2022 by the authors. Licensee MDPI, Basel, Switzerland.",

year = "2022",

month = jul,

day = "6",

doi = "10.3390/vaccines10071082",

language = "English",

volume = "10",

journal = "Vaccines",

issn = "2076-393X",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "7",

}

Abarca, K, Iturriaga, C, Urzúa, M, Le Corre, N, Pineda, A, Fernández, C, Domínguez, A, González, PA, Bueno, SM, Donato, P, Espinoza, P, Fuentes, D, González, M, Guzmán, P, Venturelli, PM, Potin, CM, Potin, M, Rojas, Á, González-Aramundiz, JV, Gálvez, NMS, Aguirre-Boza, F, Aljaro, S, Bátiz, LF, Campisto, Y, Cepeda, M, Cortés, A, López, S, Pérez, ML, Schilling, A & Kalergis, AM 2022, 'Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial', Vaccines, vol. 10, no. 7, 1082. https://doi.org/10.3390/vaccines10071082

TY - JOUR

T1 - Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults

T2 - A Randomized Clinical Trial

AU - Abarca, Katia

AU - Iturriaga, Carolina

AU - Urzúa, Marcela

AU - Le Corre, Nicole

AU - Pineda, Augusto

AU - Fernández, Carolina

AU - Domínguez, Angélica

AU - González, Pablo A.

AU - Bueno, Susan M.

AU - Donato, Paulina

AU - Espinoza, Pilar

AU - Fuentes, Daniela

AU - González, Marcela

AU - Guzmán, Paula

AU - Venturelli, Paula Muñoz

AU - Potin, Carlos M.

AU - Potin, Marcela

AU - Rojas, Álvaro

AU - González-Aramundiz, José V.

AU - Gálvez, Nicolás M.S.

AU - Aguirre-Boza, Francisca

AU - Aljaro, Sofía

AU - Bátiz, Luis Federico

AU - Campisto, Yessica

AU - Cepeda, Mariela

AU - Cortés, Aarón

AU - López, Sofía

AU - Pérez, María Loreto

AU - Schilling, Andrea

AU - Kalergis, Alexis M.

PY - 2022/7/6

Y1 - 2022/7/6

N2 - 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.

AB - 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.

KW - COVID-19

KW - CoronaVac®

KW - SARS-CoV-2

KW - immunization schedules

KW - phase III clinical trial

KW - vaccines

UR - http://www.scopus.com/inward/record.url?scp=85133863006&partnerID=8YFLogxK

U2 - 10.3390/vaccines10071082

DO - 10.3390/vaccines10071082

M3 - Article

C2 - 35891246

AN - SCOPUS:85133863006

SN - 2076-393X

VL - 10

JO - Vaccines

JF - Vaccines

IS - 7

M1 - 1082

ER -

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

Abstract

Bibliographical note

Keywords

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