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Correspondence to Author: Jorge Agustín Aguiar Santiago ¹ *, Alina Díaz Machado ² , Carlos Alberto González Delgado ² , Sonia Pérez Rodríguez ² , Iris Valdés Prado ¹ , Gerardo García Ilera ³ , Iván Luis Santos Martínez ¹ , Chabeli Rodríguez Ibarra ¹ , Maria Acelia Marrero Miragaya ⁴ , Zurina Cinza Estevez ⁵ , Gerardo Enrique Guillén Nieto ^1,6, Eduardo Pentón Arias^1,6, Julio Cesar Aguilar Rubido ¹ . 

1. Center for Genetic Engineering and Biotechnology (CIGB), Vaccine Department, Havana, Cuba
2. National Toxicology Center (CENATOX), Havana, Cuba
3. Center for Genetic Engineering and Biotechnology (CIGB), Quality Control Department, Havana, Cuba
4. National Clinical Trial Coordinating Center (CENCEC), Havana, Cuba
5. Center for Genetic Engineering and Biotechnology (CIGB), Clinical Trial Department, Havana, Cuba
6. Latin-American School of Medicine (ELAM), Havana, Cuba

DOI: 10.52338/tajoph.2025.5280

Abstract:

The combination of nasal and sublingual administration of HeberNasvac to subjects and patients during the Covid19 pandemic, demonstrated safety and local and systemic innate immune-stimulatory properties. With the aim of compare different mucosal administration routes and methods, an open-label phase II clinical trial was carried out with 40 elderly volunteers randomized into 4 groups. It was studied the expression of α, β, and γ interferons, and also, the safety of HeberNasvac. It was confirmed that HeberNasvac was safe in the 4 treatment groups. There was a generalized stimulation of the interferon genes expressions in the PBMC of most volunteers, in samples taken on days 8 and 15 after immunization, compared with day 0 (not treated). There were no significant differences between the 4 treatments, but interferon gene expression was greater on day 8 in the majority of the groups. These results shown the ability of the mucosal administration of HeberNasvac (inclusive the sublingual route alone) to induce an interferon expression stimulation in the systemic compartment of elderly volunteers and suggest its potential use in epidemics of infectious respiratory diseases. The study was indexed at the Cuban Public Registry for Clinical Trials with the number RPCEC00000326-Sp.

Keywords: HeberNasvac, sublingual immunization route, nasal immunization route, early therapy, post exposure prophylaxis, acute respiratory diseases.

Citation:

Dr. Jorge Agustín Aguiar Santiago, HeberNasvac, a Nasal and Sublingual Vaccine Formulation with Interferons Inducing Capacity. The American Journal of Public Health 2025.