Immunogenicity and safety assessment of a SARS-CoV-2 recombinant spike RBD protein vaccine (Abdala) in paediatric ages 3–18 years old: a double-blinded, multicentre, randomised, phase 1/2 clinical trial (ISMAELILLO study)

Cinza-Estévez, Zurina; Resik, Sonia; Figueroa-Baile, Nelvis L.; Oquendo-Martínez, Rachel; Campa-Legra, Ivan; Tejeda-Fuentes, Alina; Rivero-Caballero, Marila; González-García, Gloria; Chávez-Chong, Cristina O.; Alonso-Valdés, Marel; Hernández-Bernal, Francisco; Lemos-Pérez, Gilda; Campal-Espinosa, Ana; Freyre-Corrales, Giselle; Benítez-Gordillo, Delia; Gato-Orozco, Evelyn; Bartutis, Greter Susana Pérez; Mesa-Pedroso, Iliana; Bueno-Alemani, Nilda; Infante-Aguilar, Elizabeth; Reinoso, José Luis Rodríguez; Melo-Suárez, Grettel; Limonta-Fernández, Miladys; Ayala-Ávila, Marta; Muzio-González, Verena L.; López-Machado, M.A.; Rodríguez, Dolores; Basulto-Puig, J.C.; Hernández, Tomás Martín; Sánchez-Miranda, D.; Agüero-Betancourt, C.M.; Besú-García, B.; Rodríguez-Fernández, Yasmila; Guerrero-Vega, L.; GómezFonseca, I.; Ramos-Pérez, O.; Acosta-Domínguez, I.; Ronquillo-Ramirez, D.; Fernandez, Yuri Diaz; Aguilar-Soto, L.; Reíd-Montejo, J.; Palomo-Leyva, Y.; LandinFaria, M.R.; Rosendo-Domínguez, R.M.; Alonso-Manresa, C.; Marín-Pérez, D.M.; Malo-Lantigua, Y.; Rodríguez-Florat, M.C.; Delgado-Laborit, Y.; RodriguezGuevara, Y.; Peláez-González, M.; Torres-Mora, Y.; Cabrera-Hernández, O.S.; Gimarais-Varona, F.J.; Hormigot-Hernández, M.; Artola-Gutiérrez, L.V.; Gallardo-Martí, L.; Porro-Verdecia, J.; Castro-Bistorte, R.; RobertsDandie, E.; Berenguer-Pedroso, S.; Manso-García, Yudith; Mora-García, Claudio; Lastre-Muñoz, Y.; Duran-Rivero, O.; Hernández-García, B.; Escobar-Escobar, K.; CarmenatesGutiérrez, M.K.; Conde-Bello, B.; Olazabal-Linares, E.L.; Bringas-Labrada, I.; Noy-León, M.; Velazco-González, N.; Bursosa-Moreno, B.; Morell-Padrón, Y.; Rodríguez-Matos, Y.; Treto-Torguet, Y.M.; Comas-Díaz, L.; Miranda, Fernanda Moura D’Almeida; FigueredoGonzález, Y.; Quiñones-Juan, A.; Mursuli-García, I.; Giménez-Velásquez, V.M.; Hernández-Ávila, A.; Hernández-Cabrera, T.; García-Zulueta, T.; Parra-Perez, Alberto M; Cintra-Jacob, D.; Mendoza-Jiménez, María-José; Fuente-Carbonell, S.M. de la; Hernández-Eduard, B.; Ochoa-García, M.; García-Iglesias, Elizeth; Alvarez-Acosta, Anabel; Martínez-Rosales, Ricardo U.; Ávila-Díaz, Lismary; Santana-Vázquez, Z.; Mila-Cáceres, L.; Guillén-Nieto, Gerardo; Fuentes-Aguilar, Franklin; Nordelo-Valdivia, A.; González-Fernández, Nadia del Carmen; González-Sarmientos, M.; Rubio-Salinas, A.; Domínguez-Rabilero, L.C.; Espinosa-Peña, R.A.; Ramírez-Núñez, Y.; Junco-Barranco, Jesús Arturo; Díaz-González, O.; Fragas-Quintero, Anitza; Pérez-Guevara, María Teresa; Enríquez-Puertas, Juliet; Infante-Hernández, Yenicet; Cruz-Sui, Otto; Noa-Romero, Enrique; López, Y.; Sanchez-Garcia, Jonatan; Rodrı́guez-Martı́nez, Erika; Pimentel-Vázquez, Eulogio; Martinez-Diaz, Eduardo

doi:10.1016/j.eclinm.2023.102160

Cited by 5 publications

(2 citation statements)

References 25 publications

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“…Pain at the injection site is consistent with findings for other COVID-19 IM vaccines [19]. Abdala's safety has also been evaluated in children and adolescents aged 3-18 years [14], in pregnant women [15], and as a booster dose for seronegative individuals [8], with the same results.…”

Section: Discussionsupporting

confidence: 73%

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Safety and Immunogenicity of the Intranasal Vaccine Candidate Mambisa and the Intramuscular Vaccine Abdala Used as Booster Doses for COVID-19 Convalescents: A Randomized Phase 1–2 Clinical Trial

Lemos-Pérez,

Barrese-Pérez,

Chacón-Quintero

et al. 2024

Preprint

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A phase 1-2, prospective, multicenter, randomized, open-label clinical trial (Code RPCEC00000382, https://rpcec.sld.cu/trials/RPCEC00000382-En/), with parallel groups, involving 1161 participants was designed to assess safety and immunogenicity of two Cuban COVID-19 vaccines (Mambisa and Abdala) in boosting COVID-19 immunity of convalescent adults after receiving one dose of either vaccine. The main safety outcome was severe vaccination adverse events occurring in &lt;5% of vaccinees. Main immunogenicity success endpoints were ≥4-fold anti-RBD IgG seroconversion or ≥20% increase in ACE2-RBD inhibitory antibodies in &gt;55% of vaccinees in Phase 1 and &gt;70% in Phase 2. Neutralizing antibody titers against SARS-CoV-2 variants were evaluated. Both vaccines were safe; no deaths or severe adverse events occurred. Mild intensity adverse events were the most frequent (&gt;73%); headache predominated for both vaccines. Phase 1 responders were 83.3% (p = 0.0018) for Abdala. Mambisa showed similar results. Phase 2 responders were 88.6% for Abdala (p &lt;0.0001) and 74.2% for Mambisa (p = 0.0412). In both phases, anti-RBD IgG titers, inhibition percentages and neutralizing antibody titers increased significantly after the booster dose. Both vaccines were safe and their immunogenicity surpassed the study endpoints.

show abstract

Section: Discussionsupporting

confidence: 73%

“…Abdala was the first COVID-19 vaccine approved in Cuba for emergency use [11], and was a turning point for epidemic control in the country [12,13]. Studies with Abdala have also been conducted in children, adolescents and pregnant women [14,15].…”

Section: Introductionmentioning

confidence: 99%