Open label phase I/II clinical trial and predicted efficacy of SARS-CoV-2 RBD protein vaccines SOBERANA 02 and SOBERANA Plus in children

Abstract

ObjectivesTo evaluate heterologous scheme in children 3-18 y/o using two SARS-CoV-2 r-RBD protein vaccines.MethodsA phase I/II open-label, adaptive and multicenter trial evaluated the safety and immunogenicity of two doses of SOBERANA02 and a heterologous third dose of SOBERANA Plus in 350 children 3-18 y/o in Havana Cuba. Primary outcomes were safety (in phase I) and safety/immunogenicity (in phase II) measured by anti-RBD IgG ELISA, molecular and live-virus neutralization tests and specific T-cells response. An immunobridging and prediction of efficacy were additional analysis.ResultsLocal pain was the unique adverse event with >10% frequency, none was serious or severe. Two doses of SOBERANA 02 elicited humoral immune response similar to natural infection; the third dose increased significantly the response in all children, similar to that achieved in vaccinated young adults and higher than in convalescents children. The neutralizing titer was evaluated in a participant’s subset: all had neutralizing antibodies vs. alpha and delta; 97.9% vs. beta. GMT was 173.8 (CI 95% 131.7; 229.5) vs. alpha, 142 (CI 95% 101.3; 198.9) vs. delta and 24.8 (CI 95% 16.8; 36.6) vs. beta. An efficacy over 90% was estimated.ConclusionHeterologous scheme was safe and immunogenic in children 3-18 y/o. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374

SARS-CoV-2 infection in children and implications for vaccination

“…85 There is yet to be published large-scale trial data; however, a Phase I/II trial of 350 children aged 3-18 years in Cuba showed no severe adverse events and induction of neutralising antibody titres as high as convalescent children following two doses. 86 India has also approved three vaccines for use in children. The world's first DNA vaccine, 'ZyCOV-D' produced by India's Cadila, 87 found to be safe and well tolerated in 935 adolescents (12-17 years) with efficacy in preventing symptomatic PCR positive cases in those aged 12-18 years by 66.6%.…”

A Comparative Study of Immunogenicity, Antibody Persistence, and Safety of Three Different COVID-19 Boosters between Individuals with Comorbidities and the Normal Population

“…Two protein subunit COVID-19 vaccines, PastoCovac (Soberana 02) and PastoCovac Plus (Soberana Plus) have been manufactured at the Pasteur Institute of Iran in collaboration with the Finlay Vaccine Institute in Cuba. Although recent studies have confirmed the safety and immunogenicity of both vaccines in healthy adults [ 22 , 23 , 24 ] and children [ 25 , 26 ], there are not efficient associated data of these vaccines among populations with comorbidities. Therefore, we retrospectively evaluated the immunogenicity and safety of three COVID-19 boosters in people with underlying diseases in comparison with healthy individuals who had received two doses of the BBIBP-CorV vaccine and received a booster shot of the same priming vaccine or protein subunit vaccines, PastoCovac Plus or PastoCovac.…”