Immunogenicity and safety of inactivated SARS-CoV-2 vaccine (CoronaVac) using two-dose primary protocol in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up.

Autor:	Corsini CA; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Martins PFDS; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Filgueiras PS; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Lourenço AJ; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Lima AES; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Gomes SVC; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Jeremias WJ; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002.; Department of Pharmacy, Federal University of Ouro Preto (UFOP). 27, Nove, Bauxita, Ouro Preto, Brazil. 35400-000., Alves PA; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Fernandes GDR; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Castro LLME; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., de Carvalho AT; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Azevedo ACC; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Curimbaba CAL; Instituto Butantan, São Paulo, São Paulo, Brazil. 05503-900., Lorencini DA; Instituto Butantan, São Paulo, São Paulo, Brazil. 05503-900., Junior EM; Instituto Butantan, São Paulo, São Paulo, Brazil. 05503-900., da Silva VM; Instituto Butantan, São Paulo, São Paulo, Brazil. 05503-900., Cervi MC; Faculty of Medicine, University of São Paulo (USP). 455 Doutor Arnaldo Avenue, São Paulo, São Paulo, Brazil. 01246-903., Borges MC; Faculty of Medicine, University of São Paulo (USP). 455 Doutor Arnaldo Avenue, São Paulo, São Paulo, Brazil. 01246-903.; Serrana Clinical Research Center. 438, 13 de Maio, Centro, Serrana, São Paulo, Brazil. 14150-000., Nogueira ML; Faculty of Medicine of São José do Rio Preto (FAMERP). 5416 Brigadeiro Faria Lima Avenue, São José do Rio Preto, São Paulo, Brazil. 15090-000.; Hospital de Base, 5544 Brigadeiro Faria Lima Avenue, São José do Rio Preto, São Paulo State, Brazil. 15090-000.; Department of Pathology, University of Texas Medical Branch, 301 University Blvd, Galveston, TX, USA. 77555., Campos GRF; Faculty of Medicine of São José do Rio Preto (FAMERP). 5416 Brigadeiro Faria Lima Avenue, São José do Rio Preto, São Paulo, Brazil. 15090-000., Correa PRL; Belo Horizonte Municipal Health Department (SMS), 2336 Afonso Pena Avenue, Belo Horizonte, Brazil. 30130-012., Carvalho TML; Belo Horizonte Municipal Health Department (SMS), 2336 Afonso Pena Avenue, Belo Horizonte, Brazil. 30130-012., Dos Reis JGAC; Federal University of Minas Gerais (UFMG). 6627 Presidente Antônio Carlos Avenue, Belo Horizonte, Minas Gerais, Brazil. 31270-901., Reis EVS; Federal University of Minas Gerais (UFMG). 6627 Presidente Antônio Carlos Avenue, Belo Horizonte, Minas Gerais, Brazil. 31270-901., Castilho LDR; Cell Culture Engineering Laboratory (COPPE), Federal University of Rio de Janeiro (UFRJ). 550 Pedro Calmon Avenue, Rio de Janeiro, Rio de Janeiro, Brazil. 21941-598., de Lima PR; Serrana Clinical Research Center. 438, 13 de Maio, Centro, Serrana, São Paulo, Brazil. 14150-000., do Nascimento JPR; Serrana Clinical Research Center. 438, 13 de Maio, Centro, Serrana, São Paulo, Brazil. 14150-000., de Oliveira JG; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Filho OAM; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002., Grenfell RFQE; Oswaldo Cruz Foundation (FIOCRUZ). 1715 Augusto de Lima Avenue, Belo Horizonte, Minas Gerais, Brazil. 30190-002.; Federal University of Minas Gerais (UFMG). 6627 Presidente Antônio Carlos Avenue, Belo Horizonte, Minas Gerais, Brazil. 31270-901.; Department of Infectious Diseases, College of Veterinary Medicine, University of Georgia (UGA). 501 DW Brooks Drive, Athens, Georgia, USA. 30602-7387.
Jazyk:	angličtina
Zdroj:	Research square [Res Sq] 2024 Feb 29. Date of Electronic Publication: 2024 Feb 29.
DOI:	10.21203/rs.3.rs-3931021/v1
Abstrakt:	Introduction: Vaccines are essential for the prevention and control of several diseases, indeed, 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 regarding to the intensity and medium to long-term duration of a protective immune response, which may point out the need of booster doses and might support the decisions in public health. Objective: The study aims to evaluate the immunogenicity and safety of inactivated SARS-CoV-2 vaccine (CoronaVac) in a two-dose primary protocol in children and adolescent aging from 3 to 17 years old in Brazil. Methods: Participants were invited to participate in the research at two public healthcare centers located in Serrana (São Paulo) and Belo Horizonte (Minas Gerais), Brazil. Participants underwent medical interviews to gather their medical history, including COVID-19 history and medical records. Physical exams were conducted, including weight, blood pressure, temperature, and pulse rate measurements. Blood samples were obtained from the participants before vaccination, 1 month after the first dose, and 1, 3, and 6 months after the second dose and were followed by a virtual platform for monitoring post-vaccination reactions and symptoms of COVID-19. SARS-CoV-2 genome from Swab samples of COVID-19 positive individuals were sequenced by NGS. Total antibodies were measured by ELISA and neutralizing antibodies to B.1 lineage and Omicron variant (BA.1) quantified by PRNT and VNT. The cellular immune response was evaluated by flow cytometry by the quantification of systemic soluble immune mediators. Results: The follow-up of 640 participants showed that the CoronaVac vaccine (Sinovac/Butantan Institute) was able to significantly induce the production of total IgG antibodies to SARS-CoV-2 and the production of neutralizing antibodies to B.1 lineage and Omicron variant. In addition, a robust cellular immune response was observed with 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. Conclusions: The results indicate a robust and sustained immune response induced by the CoronaVac vaccine in children and adolescents up to six months, providing evidences to support the safety and immunogenicity of this effective immunizer. Competing Interests: MLN has received research grants from Instituto Butantan, Janssen Vaccines and Prevention B.V., Medicago R&D Inc, and Pfizer/BioNTech SE. RFQG has received grants from Instituto Butantan.Additional Declarations: No competing interests reported.
Databáze:	MEDLINE
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