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
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: A phase 1-2, prospective, multicenter, randomized, open-label clinical trial (Code RPCEC00000382, https://rpcec.sld.cu/trials/RPCEC00000382-En/), with parallel groups, involving 1161 participants was designed to assess 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 <5% of vaccinees. Main immunogenicity success endpoints were ≥4-fold anti-RBD IgG seroconversion or ≥20% increase in ACE2-RBD inhibitory antibodies 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%); headache 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 <0.0001) and 74.2% for Mambisa (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.
Source: Vaccines
Authors: 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 Enrique Guillén-Nieto
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,069
OpenAlex ID: W4402135690