Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up
Abstract Vaccines are essential for the prevention and control of several diseases, and monitoring the immune response generated by vaccines is crucial. The immune response generated by vaccination against SARS-CoV-2 in children and adolescents is not well defined in terms of the intensity and mediu...
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Nature Portfolio
2025-07-01
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| author | Camila Amormino Corsini Priscila Fernanda da Silva Martins Priscilla Soares Filgueiras Adelina Júnia Lourenço Ana Esther de Souza Lima Sarah Vieira Contin Gomes Wander de Jesus Jeremias Pedro Augusto Alves Gabriel da Rocha Fernandes Luciana Lisboa Mota e Castro Andrea Teixeira-Carvalho Ana Carolina Campi Azevedo Caroline De Almeida Leitao Curimbaba Daniela Aparecida Lorencini Eolo Morandi Junior Victor Mattos da Silva Maria Célia Cervi Marcos de Carvalho Borges Maurício Lacerda Nogueira Guilherme Rodrigues Fernandes Campos Paulo Roberto Lopes Correa Taciana Malheiros Lima Carvalho Jordana Grazziela Alves Coelho dos Reis Erik Vinícius de Sousa Reis Leda dos Reis Castilho Poliana Remundini de Lima João Paulo Resende do Nascimento Jaquelline Germano de Oliveira Olindo Assis Martins Filho Immunita Team Rafaella Fortini Queiroz e Grenfell |
| author_facet | Camila Amormino Corsini Priscila Fernanda da Silva Martins Priscilla Soares Filgueiras Adelina Júnia Lourenço Ana Esther de Souza Lima Sarah Vieira Contin Gomes Wander de Jesus Jeremias Pedro Augusto Alves Gabriel da Rocha Fernandes Luciana Lisboa Mota e Castro Andrea Teixeira-Carvalho Ana Carolina Campi Azevedo Caroline De Almeida Leitao Curimbaba Daniela Aparecida Lorencini Eolo Morandi Junior Victor Mattos da Silva Maria Célia Cervi Marcos de Carvalho Borges Maurício Lacerda Nogueira Guilherme Rodrigues Fernandes Campos Paulo Roberto Lopes Correa Taciana Malheiros Lima Carvalho Jordana Grazziela Alves Coelho dos Reis Erik Vinícius de Sousa Reis Leda dos Reis Castilho Poliana Remundini de Lima João Paulo Resende do Nascimento Jaquelline Germano de Oliveira Olindo Assis Martins Filho Immunita Team Rafaella Fortini Queiroz e Grenfell |
| author_sort | Camila Amormino Corsini |
| collection | DOAJ |
| description | Abstract Vaccines are essential for the prevention and control of several diseases, and monitoring the immune response generated by vaccines is crucial. The immune response generated by vaccination against SARS-CoV-2 in children and adolescents is not well defined in terms of the intensity and medium to long-term duration of protective immunity, which may indicate the need for booster doses and could support decisions in public health. The study aims to evaluate the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in a two-dose primary protocol in children and adolescents aged 3 to 17 years old in Brazil. Participants were invited to the research at two public healthcare centers located in Serrana (São Paulo) and Belo Horizonte (Minas Gerais), Brazil. They underwent medical interviews to gather their medical history, including COVID-19 history and medical records. Physical exams were conducted, which included measurements of weight, blood pressure, temperature, and pulse rate. Blood samples were obtained from the participants before vaccination, 1 month after the first dose, and at 1, 3, and 6 months after the second dose. These samples were followed up using a virtual platform to monitor post-vaccination reactions and symptoms of COVID-19. The SARS-CoV-2 genome from swab samples of COVID-19 positive individuals was sequenced using NGS. Total antibodies were measured by ELISA, and neutralizing antibodies to the B.1 lineage and Omicron variant (BA.1) were quantified by PRNT and VNT assays. The cellular immune response was evaluated by flow cytometry through the quantification of systemic soluble immune mediators. The follow-up of 640 participants showed that CoronaVac was able to significantly induce the production of total IgG antibodies to SARS-CoV-2 and the production of neutralizing antibodies to the B.1 lineage and Omicron variant. Additionally, a robust cellular immune response was observed, characterized by a wide release of pro-inflammatory and regulatory mediators in the early post-immunization moments. Adverse events recorded so far have been mild and transient, except for seven serious adverse events reported on VigiMed. The results indicate a robust and sustained immune response induced by CoronaVac in children and adolescents for up to six months, providing evidence to support the safety and immunogenicity of this effective immunizer. |
| format | Article |
| id | doaj-art-809d83e8ea6b4a8c9af50e3ea27bbb3c |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-809d83e8ea6b4a8c9af50e3ea27bbb3c2025-08-20T03:37:24ZengNature PortfolioScientific Reports2045-23222025-07-0115111610.1038/s41598-025-94596-9Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow upCamila Amormino Corsini0Priscila Fernanda da Silva Martins1Priscilla Soares Filgueiras2Adelina Júnia Lourenço3Ana Esther de Souza Lima4Sarah Vieira Contin Gomes5Wander de Jesus Jeremias6Pedro Augusto Alves7Gabriel da Rocha Fernandes8Luciana Lisboa Mota e Castro9Andrea Teixeira-Carvalho10Ana Carolina Campi Azevedo11Caroline De Almeida Leitao Curimbaba12Daniela Aparecida Lorencini13Eolo Morandi Junior14Victor Mattos da Silva15Maria Célia Cervi16Marcos de Carvalho Borges17Maurício Lacerda Nogueira18Guilherme Rodrigues Fernandes Campos19Paulo Roberto Lopes Correa20Taciana Malheiros Lima Carvalho21Jordana Grazziela Alves Coelho dos Reis22Erik Vinícius de Sousa Reis23Leda dos Reis Castilho24Poliana Remundini de Lima25João Paulo Resende do Nascimento26Jaquelline Germano de Oliveira27Olindo Assis Martins Filho28Immunita TeamRafaella Fortini Queiroz e Grenfell29Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Department of Pharmacy, Federal University of Ouro Preto (UFOP)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Instituto ButantanInstituto ButantanInstituto ButantanInstituto ButantanFaculty of Medicine, University of São Paulo (USP)Faculty of Medicine, University of São Paulo (USP)Faculty of Medicine of São José Do Rio Preto (FAMERP)Faculty of Medicine of São José Do Rio Preto (FAMERP)Belo Horizonte Municipal Health Department (SMS)Belo Horizonte Municipal Health Department (SMS)Federal University of Minas Gerais (UFMG)Federal University of Minas Gerais (UFMG)Cell Culture Engineering Laboratory (COPPE), Federal University of Rio de Janeiro (UFRJ)Serrana Clinical Research Center. 438Serrana Clinical Research Center. 438Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Oswaldo Cruz Foundation (FIOCRUZ)Abstract Vaccines are essential for the prevention and control of several diseases, and monitoring the immune response generated by vaccines is crucial. The immune response generated by vaccination against SARS-CoV-2 in children and adolescents is not well defined in terms of the intensity and medium to long-term duration of protective immunity, which may indicate the need for booster doses and could support decisions in public health. The study aims to evaluate the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in a two-dose primary protocol in children and adolescents aged 3 to 17 years old in Brazil. Participants were invited to the research at two public healthcare centers located in Serrana (São Paulo) and Belo Horizonte (Minas Gerais), Brazil. They underwent medical interviews to gather their medical history, including COVID-19 history and medical records. Physical exams were conducted, which included measurements of weight, blood pressure, temperature, and pulse rate. Blood samples were obtained from the participants before vaccination, 1 month after the first dose, and at 1, 3, and 6 months after the second dose. These samples were followed up using a virtual platform to monitor post-vaccination reactions and symptoms of COVID-19. The SARS-CoV-2 genome from swab samples of COVID-19 positive individuals was sequenced using NGS. Total antibodies were measured by ELISA, and neutralizing antibodies to the B.1 lineage and Omicron variant (BA.1) were quantified by PRNT and VNT assays. The cellular immune response was evaluated by flow cytometry through the quantification of systemic soluble immune mediators. The follow-up of 640 participants showed that CoronaVac was able to significantly induce the production of total IgG antibodies to SARS-CoV-2 and the production of neutralizing antibodies to the B.1 lineage and Omicron variant. Additionally, a robust cellular immune response was observed, characterized by a wide release of pro-inflammatory and regulatory mediators in the early post-immunization moments. Adverse events recorded so far have been mild and transient, except for seven serious adverse events reported on VigiMed. The results indicate a robust and sustained immune response induced by CoronaVac in children and adolescents for up to six months, providing evidence to support the safety and immunogenicity of this effective immunizer.https://doi.org/10.1038/s41598-025-94596-9VaccineCoronaVacSARS-CoV-2COVID-19Neutralizing antibodiesAntibodies kinetics |
| spellingShingle | Camila Amormino Corsini Priscila Fernanda da Silva Martins Priscilla Soares Filgueiras Adelina Júnia Lourenço Ana Esther de Souza Lima Sarah Vieira Contin Gomes Wander de Jesus Jeremias Pedro Augusto Alves Gabriel da Rocha Fernandes Luciana Lisboa Mota e Castro Andrea Teixeira-Carvalho Ana Carolina Campi Azevedo Caroline De Almeida Leitao Curimbaba Daniela Aparecida Lorencini Eolo Morandi Junior Victor Mattos da Silva Maria Célia Cervi Marcos de Carvalho Borges Maurício Lacerda Nogueira Guilherme Rodrigues Fernandes Campos Paulo Roberto Lopes Correa Taciana Malheiros Lima Carvalho Jordana Grazziela Alves Coelho dos Reis Erik Vinícius de Sousa Reis Leda dos Reis Castilho Poliana Remundini de Lima João Paulo Resende do Nascimento Jaquelline Germano de Oliveira Olindo Assis Martins Filho Immunita Team Rafaella Fortini Queiroz e Grenfell Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up Scientific Reports Vaccine CoronaVac SARS-CoV-2 COVID-19 Neutralizing antibodies Antibodies kinetics |
| title | Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up |
| title_full | Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up |
| title_fullStr | Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up |
| title_full_unstemmed | Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up |
| title_short | Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up |
| title_sort | immunogenicity and safety of coronavac vaccine in children and adolescents immunita 002 brazil a phase iv six month follow up |
| topic | Vaccine CoronaVac SARS-CoV-2 COVID-19 Neutralizing antibodies Antibodies kinetics |
| url | https://doi.org/10.1038/s41598-025-94596-9 |
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