Susan M Bueno1,2, Katia Abarca1,3, Pablo A González1,2, Nicolás M S Gálvez1,2, Jorge A Soto1,2, Luisa F Duarte1,2, Bárbara M Schultz1,2, Gaspar A Pacheco1,2, Liliana A González1,2, Yaneisi Vázquez1,2, Mariana Ríos1,2, Felipe Melo-González1,2, Daniela Rivera-Pérez1,2, Carolina Iturriaga3, Marcela Urzúa3, Angélica Domínguez4, Catalina A Andrade1,2, Roslye V Berríos-Rojas1,2, Gisela Canedo-Marroquín1,2, Camila Covián1,2, Daniela Moreno-Tapia1,2, Farides Saavedra1,2, Omar P Vallejos1,2, Paulina Donato5, Pilar Espinoza6,7, Daniela Fuentes8,9, Marcela González10,9, Paula Guzmán11, Paula Muñoz Venturelli12,13, Carlos M Pérez6,7, Marcela Potin14, Álvaro Rojas15, Rodrigo A Fasce16, Jorge Fernández16, Judith Mora16, Eugenio Ramírez16, Aracelly Gaete-Argel17, Aarón Oyarzún-Arrau17, Fernando Valiente-Echeverría17, Ricardo Soto-Rifo17, Daniela Weiskopf18, Alessandro Sette18,19, Gang Zeng20, Weining Meng20, José V González-Aramundiz21, Alexis M Kalergis1,2,21,22. 1. Millennium Institute on Immunology and Immunotherapy, Santiago, Chile. 2. Departamento de Genética Molecular y Microbiología, Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, Santiago, Chile. 3. Departamento de Enfermedades Infecciosas e Inmunología Pediátrica, División de Pediatría, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. 4. Departamento de Salud Pública, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. 5. Complejo Asistencial Dr. Sótero del Rio, Santiago, Chile. 6. Hospital Clínico Félix Bulnes, Santiago, Chile. 7. Facultad de Medicina y Ciencia y Facultad de Ciencias para el Cuidado de la Salud. Universidad San Sebastián, Santiago, Chile. 8. Hospital Carlos Van Buren, V Región, Chile. 9. Departamento de Pediatría, Universidad de Valparaíso, Valparaiso, Chile. 10. Hospital Dr. Gustavo Fricke, V Región, Chile. 11. Clínica Los Andes, Universidad de Los Andes, Santiago, Chile. 12. Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile. 13. The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia. 14. Clínica San Carlos de Apoquindo, Red de Salud UC Christus, Santiago, Chile. 15. Departamento de Enfermedades Infecciosas del Adulto, División de Medicina, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. 16. Departamento de Laboratorio Biomédico, Instituto de Salud Pública deChile, Santiago, Chile. 17. Laboratory of Molecular and Cellular Virology, Virology Program, Institute of Biomedical Sciences, Faculty of Medicine, Universidad de Chile, Santiago, Chile. 18. Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology, La Jolla, California, USA. 19. Department of Medicine, Division of Infectious Diseases and Global Public Health, University of California, San Diego (UCSD), La Jolla, CA, USA. 20. Sinovac Biotech, Beijing, China. 21. Departamento de Farmacia, Facultad de Química y de Farmacia. Pontificia Universidad Católica de Chile, Santiago, Chile. 22. Departamento de Endocrinología, Facultad de Medicina, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Javier Perez-Saez; Stephen A Lauer; Laurent Kaiser; Simon Regard; Elisabeth Delaporte; Idris Guessous; Silvia Stringhini; Andrew S Azman Journal: Lancet Infect Dis Date: 2020-07-14 Impact factor: 25.071
Authors: Eric Yuk Fai Wan; Yuan Wang; Celine Sze Ling Chui; Anna Hoi Ying Mok; Wanchun Xu; Vincent Ka Chun Yan; Francisco Tsz Tsun Lai; Xue Li; Carlos King Ho Wong; Esther Wai Yin Chan; Kui Kai Lau; Benjamin John Cowling; Ivan Fan Ngai Hung; Ian Chi Kei Wong Journal: Lancet Healthy Longev Date: 2022-07-04
Authors: Wasim A Prates-Syed; Lorena C S Chaves; Karin P Crema; Larissa Vuitika; Aline Lira; Nelson Côrtes; Victor Kersten; Francisco E G Guimarães; Mohammad Sadraeian; Fernando L Barroso da Silva; Otávio Cabral-Marques; José A M Barbuto; Momtchilo Russo; Niels O S Câmara; Gustavo Cabral-Miranda Journal: Vaccines (Basel) Date: 2021-11-30
Authors: Felipe Melo-González; Jorge A Soto; Liliana A González; Jorge Fernández; Luisa F Duarte; Bárbara M Schultz; Nicolás M S Gálvez; Gaspar A Pacheco; Mariana Ríos; Yaneisi Vázquez; Daniela Rivera-Pérez; Daniela Moreno-Tapia; Carolina Iturriaga; Omar P Vallejos; Roslye V Berríos-Rojas; Guillermo Hoppe-Elsholz; Marcela Urzúa; Nicole Bruneau; Rodrigo A Fasce; Judith Mora; Alba Grifoni; Alessandro Sette; Daniela Weiskopf; Gang Zeng; Weining Meng; José V González-Aramundiz; Pablo A González; Katia Abarca; Eugenio Ramírez; Alexis M Kalergis; Susan M Bueno Journal: Front Immunol Date: 2021-11-09 Impact factor: 7.561
Authors: Giuliana X Medeiros; Greyce Luri Sasahara; Jhosiene Y Magawa; João Paulo S Nunes; Fernanda R Bruno; Andreia C Kuramoto; Rafael R Almeida; Marcelo A Ferreira; Guilherme P Scagion; Érika D Candido; Fabyano B Leal; Danielle B L Oliveira; Edison L Durigon; Roberto Carlos V Silva; Daniela S Rosa; Silvia B Boscardin; Verônica Coelho; Jorge Kalil; Keity S Santos; Edecio Cunha-Neto Journal: Front Immunol Date: 2022-03-01 Impact factor: 7.561
Authors: Carlos King Ho Wong; Xi Xiong; Kristy Tsz Kwan Lau; Celine Sze Ling Chui; Francisco Tsz Tsun Lai; Xue Li; Esther Wai Yin Chan; Eric Yuk Fai Wan; Ivan Chi Ho Au; Benjamin John Cowling; Cheuk Kwong Lee; Ian Chi Kei Wong Journal: BMC Med Date: 2022-03-17 Impact factor: 8.775