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COVID-19

COVID-19 Vaccine Trial in Pediatric Ages Shows Promise

Strategic Insights

— 2 min read

Research conducted in Cuba has found that the Abdala vaccine stimulates the production of specific IgG antibodies against the RBD of SARS-CoV-2, as well as the production of ACE2 inhibition titres and neutralising antibodies in children and adolescents. The trial, known as the Ismaelillo Study, aimed to evaluate the safety and immunogenicity of two strengths of the Abdala vaccine in pediatric populations aged 3-18 years old. The study found that the vaccine was well-tolerated, with injection site pain being the most frequently reported local event, and headache being the most common systemic adverse event. The study concluded that the Abdala vaccine is a safe and effective option for pediatric vaccination against COVID-19.

Key Takeaways:

  • The Abdala vaccine stimulates the production of specific IgG antibodies against the RBD of SARS-CoV-2, as well as the production of ACE2 inhibition titres and neutralising antibodies in children and adolescents.
  • The vaccine was well-tolerated, with injection site pain being the most frequently reported local event, and headache being the most common systemic adverse event.
  • The trial involved 644 pediatric subjects, aged 3-18 years old, with 592 being enrolled and 504 completing the study.
  • The vaccine showed higher titres of specific IgG antibodies in participants who received the 50 μg dose compared to those who received the 25 μg dose.
  • The study concluded that the Abdala vaccine is a safe and effective option for pediatric vaccination against COVID-19.
  • The study was conducted in nine polyclinics in the province of Camaguey, Cuba, between July 15, 2021, and August 16, 2021.
  • The research was supported by the National Center for Genetic Engineering and Biotechnology.

Statistics:

  • 98.7% of children and adolescents in the 25 μg group showed seroconversion anti-RBD IgG, compared to 98.2% in the 50 μg group.
  • The geometric mean titres (GMT) of specific IgG antibodies were 231.3 (95% CI 222.6-240.4) in the 50 μg group, and 126.7 (95% CI 121.9-131.7) in the 25 μg group.
  • The mean ACE2 inhibition % was 59.4% in the 25 μg group, and 72.9% (p < 0.001) in the 50 μg group.

Sources:

  • 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). eClinicalMedicine, 2023;63:102160.
  • NewsRx. New COVID-19 Data Have Been Reported by Investigators at Center for Genetic Engineering and Biotechnology [Immunogenicity and Safety Assessment of a Sars-cov-2 Recombinant Spike Rbd Protein Vaccine (Abdala) In Paediatric Ages 3-18 Years Old: a ...]. Medical Letter on the CDC & FDA. November 5, 2023; p 258.

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