PMID- 35891246 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220731 IS - 2076-393X (Print) IS - 2076-393X (Electronic) IS - 2076-393X (Linking) VI - 10 IP - 7 DP - 2022 Jul 6 TI - Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial. LID - 10.3390/vaccines10071082 [doi] LID - 1082 AB - Several 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. FAU - Abarca, Katia AU - Abarca K AUID- ORCID: 0000-0003-0404-3887 AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. AD - Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile. FAU - Iturriaga, Carolina AU - Iturriaga C AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Urzua, Marcela AU - Urzua M AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. AD - Departamento de Enfermedades Infecciosas del Adulto, Division de Medicina Interna, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Le Corre, Nicole AU - Le Corre N AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Pineda, Augusto AU - Pineda A AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. AD - Medicina Fisica y Rehabilitacion, Red de Salud UC Christus, Santiago 8320000, Chile. FAU - Fernandez, Carolina AU - Fernandez C AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Dominguez, Angelica AU - Dominguez A AD - Departamento de Salud Publica, School of Medicine, Pontificia Universidad Catolica Chile, Santiago 8330077, Chile. FAU - Gonzalez, Pablo A AU - Gonzalez PA AUID- ORCID: 0000-0001-7709-6870 AD - Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile. AD - Departamento de Genetica Molecular y Microbiologia, Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Bueno, Susan M AU - Bueno SM AUID- ORCID: 0000-0002-7551-8088 AD - Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile. AD - Departamento de Genetica Molecular y Microbiologia, Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Donato, Paulina AU - Donato P AD - Complejo Asistencial Dr. Sotero del Rio, Santiago 8150215, Chile. FAU - Espinoza, Pilar AU - Espinoza P AD - Hospital Felix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastian, Santiago 8320000, Chile. FAU - Fuentes, Daniela AU - Fuentes D AD - Hospital Carlos Van Buren, Universidad de Valparaiso, Valparaiso 2340000, Chile. FAU - Gonzalez, Marcela AU - Gonzalez M AD - Hospital Gustavo Fricke, Universidad de Valparaiso, Vina del Mar 2340000, Chile. FAU - Guzman, Paula AU - Guzman P AD - Clinica Universidad de Los Andes, Servicio de Pediatria, Universidad de Los Andes, Santiago 8320000, Chile. FAU - Munoz-Venturelli, Paula AU - Munoz-Venturelli P AD - Facultad de Medicina Clinica Alemana, Universidad del Desarrollo, Santiago 8320000, Chile. FAU - Perez, Carlos M AU - Perez CM AD - Hospital Felix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastian, Santiago 8320000, Chile. FAU - Potin, Marcela AU - Potin M AD - Departamento de Enfermedades Infecciosas e Inmunologia Pediatrica, Division de Pediatria, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. AD - Clinica San Carlos de Apoquindo, Red de Salud UC, Santiago 8320000, Chile. FAU - Rojas, Alvaro AU - Rojas A AD - Departamento de Enfermedades Infecciosas del Adulto, Division de Medicina Interna, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Gonzalez-Aramundiz, Jose V AU - Gonzalez-Aramundiz JV AUID- ORCID: 0000-0001-7856-9211 AD - Departamento de Farmacia, Facultad de Quimica y de Farmacia, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Galvez, Nicolas M S AU - Galvez NMS AUID- ORCID: 0000-0003-2046-7882 AD - Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile. AD - Departamento de Genetica Molecular y Microbiologia, Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. FAU - Aguirre-Boza, Francisca AU - Aguirre-Boza F AD - Clinica Universidad de Los Andes, Unidad de Docencia, Investigacion y Extension Cientifica (DIDeP), Santiago 8320000, Chile. FAU - Aljaro, Sofia AU - Aljaro S AUID- ORCID: 0000-0002-7749-3611 AD - Clinica San Carlos de Apoquindo, Red de Salud UC, Santiago 8320000, Chile. FAU - Batiz, Luis Federico AU - Batiz LF AUID- ORCID: 0000-0002-3043-8797 AD - Escuela de Medicina, Facultad de Medicina, Universidad de los Andes, Santiago 8320000, Chile. AD - Centro de Investigacion e Innovacion Biomedica (CiiB), Universidad de los Andes, Santiago 8320000, Chile. FAU - Campisto, Yessica AU - Campisto Y AD - Complejo Asistencial Dr. Sotero del Rio, Santiago 8150215, Chile. FAU - Cepeda, Mariela AU - Cepeda M AD - Hospital Carlos Van Buren, Universidad de Valparaiso, Valparaiso 2340000, Chile. FAU - Cortes, Aaron AU - Cortes A AD - Clinica Universidad de Los Andes, Unidad de Docencia, Investigacion y Extension Cientifica (DIDeP), Santiago 8320000, Chile. FAU - Lopez, Sofia AU - Lopez S AUID- ORCID: 0000-0003-3534-7170 AD - Clinica San Carlos de Apoquindo, Red de Salud UC, Santiago 8320000, Chile. FAU - Perez, Maria Loreto AU - Perez ML AD - Hospital Felix Bulnes, Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud, Universidad San Sebastian, Santiago 8320000, Chile. FAU - Schilling, Andrea AU - Schilling A AD - Facultad de Medicina Clinica Alemana, Universidad del Desarrollo, Santiago 8320000, Chile. FAU - Kalergis, Alexis M AU - Kalergis AM AUID- ORCID: 0000-0001-7622-5263 AD - Millennium Institute on Immunology and Immunotherapy, Santiago 3871336, Chile. AD - Departamento de Genetica Molecular y Microbiologia, Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile. AD - Departamento de Endocrinologia, Facultad de Medicina, Escuela de Medicina, Pontificia Universidad Catolica de Chile, Santiago 8320000, Chile. FAU - On Behalf Of The CoronaVac Cl Study Group AU - On Behalf Of The CoronaVac Cl Study Group LA - eng GR - N/A/The Ministry of Health, Government of Chile/ GR - N/A/The Confederation of Production and Commerce (CPC), Chile/ GR - ICN09_016/The Millennium Institute on Immunology and Immunotherapy, ANID/ GR - 30488811-0/The Innovation Fund for Competitiveness FIC-R 2017/ PT - Journal Article DEP - 20220706 PL - Switzerland TA - Vaccines (Basel) JT - Vaccines JID - 101629355 PMC - PMC9323976 OTO - NOTNLM OT - COVID-19 OT - CoronaVac(R) OT - SARS-CoV-2 OT - immunization schedules OT - phase III clinical trial OT - vaccines COIS- The authors declare no conflict of interest. EDAT- 2022/07/28 06:00 MHDA- 2022/07/28 06:01 PMCR- 2022/07/06 CRDT- 2022/07/27 01:43 PHST- 2022/05/27 00:00 [received] PHST- 2022/06/26 00:00 [revised] PHST- 2022/06/28 00:00 [accepted] PHST- 2022/07/27 01:43 [entrez] PHST- 2022/07/28 06:00 [pubmed] PHST- 2022/07/28 06:01 [medline] PHST- 2022/07/06 00:00 [pmc-release] AID - vaccines10071082 [pii] AID - vaccines-10-01082 [pii] AID - 10.3390/vaccines10071082 [doi] PST - epublish SO - Vaccines (Basel). 2022 Jul 6;10(7):1082. doi: 10.3390/vaccines10071082.