Safety and Immunogenicity of the Intranasal Vaccine Candidate Mambisa and the Intramuscular Vaccine Abdala Used as Booster Doses for COVID-19 Convalescents: A Randomized Phase 1–2 Clinical Trial
Gilda Lemos-Pérez,
Yinet Barrese-Pérez,
Yahima Chacón-Quintero,
Rolando Uranga-Piña,
Yisel Avila-Albuerne,
Iglermis Figueroa-García,
Osaida Calderín-Marín,
Martha M. Gómez-Vázquez,
Marjoris Piñera-Martínez,
Sheila Chávez-Valdés,
Ricardo Martínez-Rosales,
Lismary Ávila-Díaz,
Amalia Vázquez-Arteaga,
Hany González-Formental,
Giselle Freyre-Corrales,
Edelgis Coizeau-Rodríguez,
Miladys Limonta-Fernández,
Marta Ayala-Avila,
Eduardo Martínez-Díaz,
Eulogio Pimentel-Vazquez,
Gerardo Guillen
Affiliations
Gilda Lemos-Pérez
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Yinet Barrese-Pérez
National Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba
Yahima Chacón-Quintero
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Rolando Uranga-Piña
National Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba
Yisel Avila-Albuerne
National Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba
Iglermis Figueroa-García
Hermanos Ameijeiras Clinical-Surgical Hospital, La Habana 10400, Cuba
Osaida Calderín-Marín
Manuel Ascunce Domenech Provincial Clinical-Surgical Teaching Hospital, Camagüey 70100, Cuba
Martha M. Gómez-Vázquez
Pedro Raúl Sánchez Teaching Polyclinic, Pinar del Río 20100, Cuba
Marjoris Piñera-Martínez
Saturnino Lora Provincial Clinical-Surgical Hospital, Santiago de Cuba 90100, Cuba
Sheila Chávez-Valdés
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Ricardo Martínez-Rosales
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Lismary Ávila-Díaz
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Amalia Vázquez-Arteaga
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Hany González-Formental
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Giselle Freyre-Corrales
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Edelgis Coizeau-Rodríguez
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Miladys Limonta-Fernández
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Marta Ayala-Avila
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
Eduardo Martínez-Díaz
Ministry of Science, Technology and Environment (CITMA), La Habana 10400, Cuba
Eulogio Pimentel-Vazquez
Biotechnology and Pharmaceutical Industries Group (BioCubaFarma), La Habana 10800, Cuba
Gerardo Guillen
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba
A phase 1–2, prospective, multicenter, randomized, open-label clinical trial (Code RPCEC00000382), with parallel groups, involving 1161 participants, was designed to assess the safety and immunogenicity of two Cuban COVID-19 vaccines (Mambisa and Abdala) in boosting COVID-19 immunity of convalescent adults after receiving one dose of either vaccine. The main safety outcome was severe vaccination adverse events occurring in 55% of vaccinees in Phase 1 and >70% in Phase 2. Neutralizing antibody titers against SARS-CoV-2 variants were evaluated. Both vaccines were safe—no deaths or severe adverse events occurred. Mild intensity adverse events were the most frequent (>73%); headaches predominated for both vaccines. Phase 1 responders were 83.3% (p = 0.0018) for Abdala. Mambisa showed similar results. Phase 2 responders were 88.6% for Abdala (p p = 0.0412). In both phases, anti-RBD IgG titers, inhibition percentages and neutralizing antibody titers increased significantly after the booster dose. Both vaccines were safe and their immunogenicity surpassed the study endpoints.
