Mambisa: Subunit vaccine candidate against SARS-CoV-2

Authors

Keywords:

SARS-CoV-2; mucosal immunity

Abstract

Introduction: Nasal immunization offers advantages for protection against respiratory infections, which are characterized by high transmissibility. It also provides a safe and more acceptable route for administering booster doses in individuals previously immunized or infected with SARS‑CoV‑2.

Objectives: To evaluate the safety and immunogenicity of the subunit vaccine candidate Mambisa, administered intranasally in individuals previously infected with SARS‑CoV‑2. To demonstrate its ability to induce antibodies that inhibit the binding of the virus to its cellular receptor, both systemically and at the mucosal level, in adults younger and older than 60 years

Methods: The formulation includes 40 µg of HBcAg as a nasal immunopotentiator and 50 µg of the RBD antigen, produced by genetic engineering in Escherichia coli and Pichia pastoris. A phase I–II, prospective, multicenter, randomized, open‑label clinical trial was conducted in adults aged 19 to 80 years convalescing from COVID‑19, administering a single dose. Phase I explored different intranasal delivery devices to select the most suitable one, which was subsequently used in Phase II.

Results: Phase I evaluated an intranasal atomizer, a nasal spray, and a dropper, all meeting success criteria; the atomizer was selected for Phase II, which included 513 volunteers. Induction of IgA and IgG in serum and nasal secretions was observed, with the ability to inhibit RBD–ACE2 interaction. The immune response was significant in both age groups.

Conclusions: Mambisa, administered intranasally as a booster in COVID‑19 convalescents, was safe, well tolerated, and capable of enhancing immunity regardless of age.

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Author Biography

Gerardo Enrique Guillen Nieto, Centro de Ingeniería Genética y Biotecnología. La Habana. Escuela Latinoamericana de Medicina. La Habana. Academia de Ciencias de Cuba. La Habana.

No existe conflicto de intereses.

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Published

2026-02-27

How to Cite

Guillen Nieto, G. E., Lemos Pérez, G., Barrese Pérez, Y., Avila Albuerne, Y., Figueroa García, I., Gómez Vázquez, M. M., … Martínez Díaz, E. (2026). Mambisa: Subunit vaccine candidate against SARS-CoV-2. Anales De La Academia De Ciencias De Cuba, 15(4), e3257. Retrieved from https://revistaccuba.sld.cu/index.php/revacc/article/view/3257

Issue

Vol. 15 No. 4: Octubre-Diciembre 2025

Section

Contribuciones especiales

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Copyright (c) 2026 Gerardo Enrique Guillen Nieto, Gilda Lemos Pérez, Yinet Barrese Pérez, Yisel Avila Albuerne, Iglermis Figueroa García, Martha M. Gómez Vázquez, Marjoris Pinera Martínez, Rolando Uranga Pina, Yahima Chacón Quintero, Sheila Chávez Valdés, Ricardo Ulises Martínez Rosales, Lismary Ávila Acosta, Amalia Vázquez Arteaga, Hany González Formental, Giselle Freyre Corrales, Edelgis Coizeau Rodríguez, Miladys Limonta Fernández, Enrique Iglesias Pérez, Mónica Bequet Romero, Julio Cesar Aguilar Rubido, Eduardo Penton Arias, Verena Muzio González, Zurina Cinza Estevez, Francisco Hernandez Bernal, Glay Chinea Santiago, Diamile González Roche, Alejandro Miguel Martín Dunn, Iris Valdés Prado, Jorge Aguiar Santiago, Guadalupe Guzmán Tirado, Maylin Alvarez Vera, Oscar Cruz Gutierrez, Jesús Zamora Sanchez, Jorge Luis Vega Elias, Maribel Vega Simón, Mabel Izquierdo López, Lourdes Costa Anguiano, Isabel Gonzalez Moya, Camila Canaán Haden Ayala, Ania Cabrales Rico, Mariela Pérez de la Iglesias, Ariel Palenzuela Diaz, Irinia Valdivia Alvarez, Gleysin Cabrera Herrera, Luis Javier González López, Dionne Casillas Casanova, Juan Miguel Rivera Martín, Niurka Carlos Pías, Jorge Castro Velazco, Yassel Ramos Gómez, Ana Campal Espinosa, Franklyn Fuentes Aguilar, Ingrid Rodríguez Alonso, Lizet Aldana Velazco, Pedro Puente Pérez, Yilian Bermudez Alvarez, Ana Aguilera Barreto, Odalys Ruiz Hernández, Zeila Santana Vázquez, Carmen Chuay Silva, Edith Suzarte Portal, Laura Lazo Vazquez, Yusleidy de la Caridad Perez Fuentes, Jorge Valdés Hernández, Marta Ayala Avila, Eulogio Pimentel Vazquez, Eduardo Martínez Díaz

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