The immunogen of the Center for Genetic Engineering and Biotechnology in clinical development phase is being tested for use in convalescents and as a booster dose.
- Stimulates immunity in the
nasal passages, site of entry of SARS-CoV-2. - Based on recombinant proteins produced in a safe and effective technological platform in use for over 25 years.
- First protein vaccine candidate for nasal use against COVID-19 that began a phase of clinical studies in humans in the world.
Based on its previous experiences in the research and production of recombinant vaccines, the CIGB is developing a project aimed at obtaining the anti-COVID-19 Mambisa vaccine for use by nasal administration.
Unlike injectable vaccines, those administered by the nasal route stimulate local immunity in the nasal mucosa, site of entry of SARS-CoV-2, allowing early neutralization of the pathogen.
The vaccine candidate Mambisa consists of a combination of two recombinant proteins: the RBD protein from the spike of the SARS-CoV-2 virus, and the protein from the nucleocapsid of the hepatitis B virus.
Previous research by the CIGB has shown that the protein from the Hepatitis B virus nucleocapsid has a powerful adjuvant effect in stimulating nasal immunity, which led to its use in the production and sanitary registration of the HeberNasvac therapeutic vaccine against hepatitis B in 2015.
Both recombinant antigens are produced in expression platforms based on technologies used for more than 25 years for the production of proteins that have been shown to be safe, functional, and effective as vaccines.
The Abdala vaccine was designed to stimulate a broad immune response that includes both systemic immunity (neutralizing IgG) and local immunity (mucosal IgA, T cells) in the nasal cavity and respiratory tract. Local mucosal immunity is important in blocking replication of the SARS-CoV-2 virus. in the nose, which is the starting point and spread of the disease. Recent studies have shown that, in the absence of mucosal immunity, the nasal cavity can become a reservoir for the coronavirus, putting the patient at risk of reinfection or transmission of the disease to others. Nasal mucosal immunity is significantly stimulated by intranasal administration of a vaccine.
The CIGB developed an adaptive, randomized, parallel group phase I/II clinical trial to evaluate the safety and immunogenicity in adults of the Mambisa vaccine candidate for use as a booster dose in 120 volunteers convalescing from COVID-19. During phase I, three nasal administration devices were compared, two of them in the form of spray, and another in the form of drops. Additional details of this trial can be reviewed on the website (https://rpcec.sld.cu/ensayos/RPCEC00000382-Sp) of the Cuban Public Registry of Clinical Trials.
In all three devices tested, Mambisa proved to be a safe vaccine. The adverse events described were mostly mild, and no serious events were described. All groups were able to induce an anti-RBD response more than four times compared to the initial level, as well as an increase of more than 20% in the inhibitory capacity against the SARS-CoV-2 virus, both at the systemic level and in the nasal mucosa. The phase II study is currently recruiting volunteers.
In addition, a phase II “Baconao” clinical study is underway https://rpcec.sld.cu/essayos/RPCEC00000398-Sp for the evaluation of the immunogenicity and safety of a booster dose with Mambisa in 2220 individuals immunized with the vaccine Abdala of the CIGB.
Recent publications in important scientific journals in the world, as well as relevant international immunology specialists, have pointed out the great prospects and potential advantages of nasal vaccines to combat the COVID-19 pandemic. However, currently there are only 11 vaccine candidates in clinical research phases with the intention of being used by nasal administration, among which Mambisa has been recognized.
The Mambisa vaccine candidate from the Center for Genetic Engineering and Biotechnology is one of the immunogens for nasal use against COVID-19 with the most advanced research at this time in the world, endorsed of high security because it is based on protein antigens produced on a platform with a history of safe and effective use for over 25 years.
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