Real-World Effectiveness of the OBERANA02 and SOBERANA-Plus Vaccine Combination in Children 2 to 11 Years of Age during the SARS CoV-2 Omicron Wave in Cuba: A Regression Discontinuity Study

Eugenia-Toledo-Romani, Maria; Valenzuela-Silva, Carmen; Montero-Díaz, Minerva; Iniguez-Rojas, Luisa; Rodríguez-González, Meiby; Martinez-Cabrera, Mery; Puga-Gómez, Rinaldo; German-Almeida, Angel; Fernández-Castillo, Sonsire; Climent-Ruíz, Yanet; Santana-Mederos, Darielys; Lopez-Gonzalez, Lissette; Morales-Suarez, Ileana; Doroud, Delaram; Valdés-Balbín, Yury; García-Rivera, Dagmar; Stuyft, Patrick Van der; Vérez-Bencomo, Vicente

doi:10.2139/ssrn.4397049

Cited by 2 publications

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“…They were vaccinated every 28 days with the heterologous scheme of two doses of SOBERANA ® 02 and a third dose with SOBERANA ® Plus. The study was conducted on October 2021 during the prevalence of the Delta variant and before the appearance of the Omicron variant [18]. Key inclusion criteria were weight, height, nutritional assessment, physical examination without alterations, clinical laboratory results within the range of reference values, and microbiology laboratory tests.…”

Section: Subjects and Ethicsmentioning

confidence: 99%

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

Pérez-Nicado,

Massa,

Rodríguez-Noda

et al. 2023

Vaccines

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(1) Background: In children, SARS-CoV-2 infection is mostly accompanied by mild COVID-19 symptoms. However, multisystem inflammatory syndrome (MIS-C) and long-term sequelae are often severe complications. Therefore, the protection of the pediatric population against SARS-CoV-2 with effective vaccines is particularly important. Here, we compare the humoral and cellular immune responses elicited in children (n = 15, aged 5–11 years) vaccinated with the RBD-based vaccines SOBERANA® 02 and SOBERANA® Plus combined in a heterologous scheme with those from children (n = 10, aged 4–11 years) who recovered from mild symptomatic COVID-19. (2) Methods: Blood samples were taken 14 days after the last dose for vaccinated children and 45–60 days after the infection diagnosis for COVID-19 recovered children. Anti-RBD IgG and ACE2-RBD inhibition were assessed by ELISA; IgA, cytokines, and cytotoxic-related proteins were determined by multiplex assays. Total B and T cell subpopulations and IFN-γ release were measured by multiparametric flow cytometry using a large panel of antibodies after in vitro stimulation with S1 peptides. (3) Results: Significant higher levels of specific anti-RBD IgG and IgA and ACE2-RBD inhibition capacity were found in vaccinated children in comparison to COVID-19 recovered children. Th1-like and Th2-like CD4+ T cells were also significantly higher in vaccinated subjects. IFN-γ secretion was higher in central memory CD4+ T cells of COVID-19 recovered children, but no differences between both groups were found in the CD4+ and CD8+ T cell effector, terminal effector, and naïve T cell subpopulations. In contrast to low levels of IL-4, high levels of IL-2, IL-6, IFN-γ, and IL-10 suggest a predominant Th1 cell polarization. Cytotoxic-related proteins granzyme A and B, perforin, and granulin were also found in the supernatant after S1 stimulation in both vaccinated and recovered children. (4) Conclusions: Vaccination with the heterologous scheme of SOBERANA® 02/SOBERANA® Plus induces a stronger antibody and cellular immune response compared to natural infections in young children.

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Section: Subjects and Ethicsmentioning

confidence: 99%

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

Pérez-Nicado,

Massa,

Rodríguez-Noda

et al. 2023

Vaccines

Self Cite

View full text Add to dashboard Cite

show abstract

“…They were vaccinated every 28 days with the heterologous scheme of two doses of SOBERANA ® 02 and a third dose with SOBERANA ® Plus. The study was conducted during October 2021 with a prevalence of delta variant and before the appearance of omicron [14].…”

Section: Subjects and Ethicsmentioning

confidence: 99%

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

Perez-Nicado,

Massa,

Rodriguez-Noda

et al. 2023

Preprint

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(1) Background: SARS-CoV-2 infection is mostly accompanied by mild COVID-19 symptoms in children. However, the multisystem inflammatory syndrome (MIS-C) and long-term sequelae are often severe complications. Therefore, the protection of the pediatric population against SARS-CoV-2 with effective vaccines is particularly important. Here we compare the humoral and cellular immune responses elicited in children (n=15) aged 5-11 years vaccinated with RBD-based vaccines combined in a heterologous scheme of SOBERANA® 02 and SOBERANA® Plus with those from children (n=10) aged 4-11 years who recovered from mild symptomatic COVID-19. (2) Methods: Blood samples were taken 14 days after last dose for vaccinated and 45-60 days after the infection diagnosis for COVID-19 recovered children. Anti-RBD IgG and ACE2-RBD inhibition were assessed by ELISA; IgA, cytokine and cytotoxic related proteins profile were determined by multiplex assays. Total B and T cell subpopulations and IFN-γ release were measured by multiparametric flow cytometry using a large panel of antibodies after in vitro stimulation with S1 peptides. (3) Results: Significant higher levels of specific anti-RBD IgG and IgA and ACE2-RBD inhibition capacity were found in vaccinated children in comparison to COVID-19 recovered children. Th1-like and Th2-like CD4+ T cells were also significantly higher in vaccinated subjects. IFN-γ secretion were higher in central memory CD4+ T cells of COVID-19 recovered children, but no differences between both groups were found in CD4+ and CD8+ T cells effector, terminal and naïve T cell subpopulations. High levels of IL-2, IL-6, IFN-γ and IL-10 in contrast to low levels of IL-4 suggesting a predominant Th1 cell polarization. Cytotoxic-related proteins granzyme A and B, perforin and granulin were also found in the supernatant after S1 stimulation in both vaccinated and recovered children. (4) Conclusions: Vaccination with the heterologous scheme of SOBERANA® 02/ SOBERANA® Plus induces strong antibody and cellular immune response compared to natural infections of young children.

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Real-World Effectiveness of the OBERANA02 and SOBERANA-Plus Vaccine Combination in Children 2 to 11 Years of Age during the SARS CoV-2 Omicron Wave in Cuba: A Regression Discontinuity Study

Cited by 2 publications

References 0 publications

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children

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