Introduction:

SOBERANA®Plus vaccine was evaluated in COVID-19 convalescents in the face of the emergence of new SARS-CoV-2 variants. SOBERANA®Plus is based on the recombinant receptor binding domain (RBD) protein dimer with sequence 319-354.

Methods:

Two clinical studies were executed, in which one dose of the vaccine was evaluated. In the open-label Phase I clinical trial, in 30 COVID-19 convalescents with asymptomatic and mild clinical presentation, aged 22 to 57 years, safety, reactogenicity and immunogenicity were evaluated, by means of anti-RBD ELISA, in vitro RBD:hACE2 inhibition test, viral neutralization test and evaluation of effector T cells. Registered in the Cuban Public Registry of Clinical Trials, WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000349-Sp. The randomized and placebo-controlled Phase II study, in 450 COVID-19 convalescents, asymptomatic, mild or moderate, between 19 and 78 years of age. Reactogenicity and humoral immunogenicity were evaluated. WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000366-Sp.

Results and Discussion:

No serious adverse events were reported in both studies. Mild events predominated, being the most common, the local pain. The vaccine stimulated an increase of >21-fold in the anti-RBD IgG antibodies 28 days after vaccination in the Phase I trial, and >31-fold in the Phase II trial. Median of inhibitory antibody titers in both phases were 94.0%. A significant increase in viral neutralizing titers against D614G, alpha, beta and delta variants, and specific IFN-γ- and TNF-α-producing T cells was detected. Conclusions, SOBERANA®Plus has demonstrated an excellent safety profile and a single dose was able to effectively boost pre-existing natural immunity.

        · resumo em Espanhol     · texto em Espanhol     · Espanhol ( pdf )