Comparative Immunogenicity and Safety of Spikogen®, a Recombinant Sars-Cov-2 Spike Protein Vaccine in Children and Young Adults: An Immuno-Bridging Clinical Trial Publisher Pubmed



Tabarsi P¹ ; Mamishi S^{2, 3} ; Anjidani N⁴ ; Shahpari R⁴ ; Kafi H⁴ ; Fallah N⁴ ; Yazdani B⁴ ; Ebrahimi A⁴ ; Roshanzamir K⁵ ; Ebrahimi H⁵ ; Oveisi S⁵ ; Soltani A⁵ ; Petrovsky N⁶ ; Barati S⁴ Show Affiliations
Source: International Immunopharmacology Published:2024

Abstract

Background: SpikoGen® is a recombinant subunit spike protein ectodomain vaccine manufactured in insect cells and formulated with the novel polysaccharide-based Advax-CpG55.2 adjuvant. This study aimed to compare the immunogenicity and safety of SpikoGen® vaccine in children, adolescents and young adults. Methods: This was a non-randomized, three-arm, open-label, parallel-group, immuno-bridging, non-inferiority trial to compare the immunogenicity and safety of a primary course of two intramuscular doses of SpikoGen® vaccine in children aged 5 to < 12 years, adolescents aged 12 to < 18 years and young adults aged 18 to 40 years. Children 5–12 years received a half dose of 12.5 μg spike protein, whereas the other groups received the full vaccine dose. Vaccine immunogenicity was evaluated via assessment of serum anti-spike and neutralizing antibodies 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Safety assessments including serious adverse events were continued through six months after the second dose in children and adolescents. Results: Two weeks after the second dose, seroconversion rates for neutralizing antibody levels were not significantly different for children (59.50 %), adolescents (52.06 %) and adults (56.01 %). The 95 % confidence interval of the difference in seroconversion rates between children and adults was within the prespecified non-inferiority margin of 10 % (−12 % to 5 %). SpikoGen® vaccine was well tolerated in all age groups with the most common solicited adverse events being injection site pain and fatigue which were generally transient and mild. Conclusion: SpikoGen® vaccine was shown to be safe, well tolerated and immunogenic in children as young as 5 years of age, with non-inferior responses to those seen in adults. The Iranian FDA authorisation of SpikoGen® vaccine is now extended down to 5 years of age. © 2023 Elsevier B.V.