Immunogenicity of the Abdala vaccine in children and adolescents
Keywords:
immunogenicity, viral neutralization, SARS-CoV-2, vaccineAbstract
Introduction: COVID-19 infection in pediatric patients is asymptomatic or presents with varied clinical symptoms, usually mild or moderate. A minority of children may progress to severe forms of the disease. Immunization of the pediatric population was necessary to prevent severe forms of the disease and its sequelae. The Center for Genetic Engineering and Biotechnology developed the safe and immunogenic Abdala vaccine.
Objective: To evaluate the immunogenicity of the Abdala vaccine against SARS-CoV-2 in children and adolescents.
Methods: An open-label, monocentric, uncontrolled phase 2 clinical trial was conducted at the Centro de Investigaciones Médico Quirúrgicas (Center for Medical and Surgical Research) from September to November 2021, in 645 children aged 3 to 18 years, whether or not exposed to the SARS-CoV-2 virus. The variables evaluated were: inhibition of the interaction of the receptor-binding domain by the angiotensin-converting enzyme 2, and viral neutralization by the Abdala vaccine. Absolute and relative frequency distributions were used to express immunogenicity using ANOVA or its corresponding alternative (Kruskall-Wallis). The chi-square statistic or Fisher's exact test (p=0.05) was used in the evaluation between two variables.
Results: 95 % of subjects had an inhibition percentage above 30%, and viral neutralization was 98 %.
Conclusions: The Abdala vaccine is immunogenic and achieves a demonstrated functional response by inducing SARS-CoV-2 neutralization in children and adolescents, whether or not exposed to the viral infection.
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Copyright (c) 2025 Laura Alvaré Alvaré, Francisco Hernández Bernal, Mairaly Porta Díaz , Danusia Felipe Mallea , Alena Salvato Dueñas
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