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
Author:
Corsini Camila Amormino1, Martins Priscila Fernanda da Silva1, Filgueiras Priscilla Soares1, Lourenço Adelina Júnia1, Lima Ana Esther de Souza1, Gomes Sarah Vieira Contin1, Jeremias Wander de Jesus2, Alves Pedro Augusto1, Fernandes Gabriel da Rocha1, Castro Luciana Lisboa Mota e1, Teixeira-Carvalho Andrea1, Campi-Azevedo Ana Carolina1, Curimbaba Caroline De Almeida Leitao3, Lorencini Daniela Aparecida3, Junior Eolo Morandi3, Silva Victor Mattos da3, Cervi Maria Célia4, Borges Marcos de Carvalho4, Nogueira Maurício Lacerda5, Campos Guilherme Rodrigues Fernandes5, Correa Paulo Roberto Lopes6, Carvalho Taciana Malheiros Lima6, Reis Jordana Grazziela Alves Coelho dos7, Reis Erik Vinicius de Sousa7, Castilho Leda dos Reis8, de Lima Poliana Remundini9, Nascimento João Paulo Resende do9, de Oliveira Jaquelline Germano1, Martins-Filho Olindo Assis1, Grenfell Rafaella Fortini Queiroz e1, Team Immunita
Affiliation:
1. Oswaldo Cruz Foundation (FIOCRUZ) 2. Federal University of Ouro Preto (UFOP) 3. Instituto Butantan 4. University of São Paulo (USP) 5. Faculdade de Medicina de São José do Rio Preto 6. Belo Horizonte Municipal Health Department (SMS) 7. Federal University of Minas Gerais (UFMG) 8. Federal University of Rio de Janeiro (UFRJ) 9. Serrana Clinical Research Center
Abstract
Abstract
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.
Publisher
Research Square Platform LLC
Reference17 articles.
1. An affordable anti-SARS-COV-2 spike protein ELISA test for early detection of IgG seroconversion suited for large-scale surveillance studies in low-income countries;Renata ALVIM,2020 2. Booster dose of BNT162b2 after two doses of CoronaVac improves neutralization of SARS-CoV-2 Omicron variant. Communications medicine, v. 2, n. 1;Guilherme CAMPOS,2022 3. CORMAN, V. et al. Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR-protocol and preliminary evaluation as of Jan 13, 2020. Available from www.who.int/docs/default-source/coronaviruse/wuhan-virus-assay-v1991527e5122341d99287a1b17c111902. pdf? sfvrsn = d381fc88_2, 2020. 4. ViralFlow: A versatile automated workflow for SARS-CoV-2 genome assembly, lineage assignment, mutations and intrahost variant detection;Filipe Zimmer DEZORDI;Viruses, v.,2022 5. FERNANDES, Eder Gatti et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in inadvertently vaccinated healthy children. Revista do Instituto de Medicina Tropical de São Paulo, v. 63, p. e83, 2021.
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