Preclinical and clinical evaluation of SOBERANA® 01. Vaccine candidate against COVID-19
Keywords:
COVID-19, SARS-CoV-2, Vaccine, Neutralizing antibodiesAbstract
Introduction: SOBERANA® 01 was developed at the Finlay Vaccine Institute to combat the epidemic caused by the SARS-CoV-2 virus. This candidate is based on the Receptor Binding Domain (RBD) in dimeric form combined with purified vesicles from outer membrane of serogroup B meningococcus as immunopotentiator of the immune response adsorbed on aluminum hydroxide.
Methods: The antigen was designed with the peculiarity of having a free cysteine at position 538, which allows the formation of RBD dimers. In preclinical studies it was evaluated the immunogenicity of the dimer combined with the outer membrane vesicles and they were performed toxicological studies. In addition, it was designed a Phase I clinical study in subjects from 19 to 59 years old.
Results: The antigenic presentation in the form of dimer combined with the vesicles proved to be safe and immunogenic in animal models, observing a significant increase in the immune response when compared to the monomeric form. During the Phase I clinical evaluation, which included apparently healthy subjects between the ages of 19 and 59, it was demonstrated that SOBERANA® 01 lead to a significant increase in the neutralizing antibody response compared to the use of aluminum hydroxide as the sole adjuvant. After the third dose, 100% of the subjects seroconverted to the group immunized with SOBERANA® 01. Conclusions: It was demonstrated the immunogenicity and neutralizing capacity of the antibodies induced by SOBERANA® 01. The analysis of the sera of the vaccinated persons demonstrated that the formulation containing the OMVs causes a more potent neutralizing effect against several RBD mutants present in VOCs, including the RBD triple mutants of the beta variant.
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