Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up
Rattachement africain : br, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Immunogenicity and safety of CoronaVac vaccine in children and adolescents (Immunita-002, Brazil): A phase IV six-month follow up
- Date Crossref
- 02/07/2025
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Fundação Oswaldo Cruz pays non établi dans la noticeStructure de recherche
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Universidade Federal de Ouro Preto pays non établi dans la noticeUniversité ou école supérieure
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Instituto Butantan pays non établi dans la noticeStructure de recherche
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Universidade de São Paulo pays non établi dans la noticeUniversité ou école supérieure
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Faculdade de Medicina de São José do Rio Preto pays non établi dans la noticeUniversité ou école supérieure
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Hospital de Base pays non établi dans la noticeÉtablissement de santé
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Dr. Euryclides Hospital de Jesus Zerbini pays non établi dans la noticeÉtablissement de santé
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The University of Texas Medical Branch at Galveston Department of Pathology pays non établi dans la noticeUniversité ou école supérieure
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Prefeitura Municipal de Belo Horizonte pays non établi dans la noticeOrganisme public
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Universidade Federal de Minas Gerais pays non établi dans la noticeUniversité ou école supérieure
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Universidade Federal do Rio de Janeiro pays non établi dans la noticeUniversité ou école supérieure
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University of Georgia pays non établi dans la noticeUniversité ou école supérieure
Fundação Oswaldo Cruz, Universidade Federal de Ouro Preto et Instituto Butantan, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.