Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac<sup>®</sup>, 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 Co...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-07-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/7/1082 |
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| author | 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. 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 Andrea Schilling Alexis M. Kalergis on behalf of the CoronaVac03CL Study Group |
| author_facet | 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. 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 Andrea Schilling Alexis M. Kalergis on behalf of the CoronaVac03CL Study Group |
| author_sort | Katia Abarca |
| collection | DOAJ |
| description | Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac<sup>®</sup>, 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<sup>®</sup> 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<sup>®</sup> is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization. |
| first_indexed | 2024-03-09T10:10:47Z |
| format | Article |
| id | doaj.art-cf5a17f62e894631ab713b4f3f4ddabd |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T10:10:47Z |
| publishDate | 2022-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-cf5a17f62e894631ab713b4f3f4ddabd2023-12-01T22:46:18ZengMDPI AGVaccines2076-393X2022-07-01107108210.3390/vaccines10071082Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical TrialKatia Abarca0Carolina Iturriaga1Marcela Urzúa2Nicole Le Corre3Augusto Pineda4Carolina Fernández5Angélica Domínguez6Pablo A. González7Susan M. Bueno8Paulina Donato9Pilar Espinoza10Daniela Fuentes11Marcela González12Paula Guzmán13Paula Muñoz-Venturelli14Carlos M. Pérez15Marcela Potin16Álvaro Rojas17José V. González-Aramundiz18Nicolás M. S. Gálvez19Francisca Aguirre-Boza20Sofía Aljaro21Luis Federico Bátiz22Yessica Campisto23Mariela Cepeda24Aarón Cortés25Sofía López26María Loreto Pérez27Andrea Schilling28Alexis M. Kalergis29on behalf of the CoronaVac03CL Study GroupDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Salud Pública, School of Medicine, Pontificia Universidad Católica Chile, Santiago 8330077, ChileMillennium Institute on Immunology and Immunotherapy, Santiago 3871336, ChileMillennium Institute on Immunology and Immunotherapy, Santiago 3871336, ChileComplejo Asistencial Dr. Sótero del Río, Santiago 8150215, ChileHospital Félix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastián, Santiago 8320000, ChileHospital Carlos Van Buren, Universidad de Valparaíso, Valparaíso 2340000, ChileHospital Gustavo Fricke, Universidad de Valparaíso, Viña del Mar 2340000, ChileClínica Universidad de Los Andes, Servicio de Pediatría, Universidad de Los Andes, Santiago 8320000, ChileFacultad de Medicina Clínica Alemana, Universidad del Desarrollo, Santiago 8320000, ChileHospital Félix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastián, Santiago 8320000, ChileDepartamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Enfermedades Infecciosas del Adulto, División de Medicina Interna, School of Medicine, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileDepartamento de Farmacia, Facultad de Química y de Farmacia, Pontificia Universidad Católica de Chile, Santiago 8330077, ChileMillennium Institute on Immunology and Immunotherapy, Santiago 3871336, ChileClínica Universidad de Los Andes, Unidad de Docencia, Investigación y Extensión Científica (DIDeP), Santiago 8320000, ChileClínica San Carlos de Apoquindo, Red de Salud UC, Santiago 8320000, ChileEscuela de Medicina, Facultad de Medicina, Universidad de los Andes, Santiago 8320000, ChileComplejo Asistencial Dr. Sótero del Río, Santiago 8150215, ChileHospital Carlos Van Buren, Universidad de Valparaíso, Valparaíso 2340000, ChileClínica Universidad de Los Andes, Unidad de Docencia, Investigación y Extensión Científica (DIDeP), Santiago 8320000, ChileClínica San Carlos de Apoquindo, Red de Salud UC, Santiago 8320000, ChileHospital Félix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastián, Santiago 8320000, ChileFacultad de Medicina Clínica Alemana, Universidad del Desarrollo, Santiago 8320000, ChileMillennium Institute on Immunology and Immunotherapy, Santiago 3871336, ChileSeveral vaccines have been developed to control the COVID-19 pandemic. CoronaVac<sup>®</sup>, 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<sup>®</sup> 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<sup>®</sup> is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.https://www.mdpi.com/2076-393X/10/7/1082CoronaVac<sup>®</sup>phase III clinical trialSARS-CoV-2COVID-19vaccinesimmunization schedules |
| spellingShingle | 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. 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 Andrea Schilling Alexis M. Kalergis on behalf of the CoronaVac03CL Study Group Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial Vaccines CoronaVac<sup>®</sup> phase III clinical trial SARS-CoV-2 COVID-19 vaccines immunization schedules |
| title | Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial |
| title_full | Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial |
| title_fullStr | Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial |
| title_full_unstemmed | Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial |
| title_short | Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial |
| title_sort | safety and non inferiority evaluation of two immunization schedules with an inactivated sars cov 2 vaccine in adults a randomized clinical trial |
| topic | CoronaVac<sup>®</sup> phase III clinical trial SARS-CoV-2 COVID-19 vaccines immunization schedules |
| url | https://www.mdpi.com/2076-393X/10/7/1082 |
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