biostudies-literatureUnknown12(9)Lemos-Perez GA 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 <5% of vaccinees. Main immunogenicity success endpoints were a ≥4-fold anti-RBD IgG seroconversion or a ≥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 eveVaccines1001https://www.ebi.ac.uk/biostudies/studies/S-EPMC11435458biostudies-literatureSafety 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.PMC11435458Martinez-Diaz EUranga-Pina RAvila-Diaz LMartinez-Rosales RGomez-Vazquez MMBarrese-Perez YAyala-Avila MChacon-Quintero YChavez-Valdes SLemos-Perez GAvila-Albuerne YFreyre-Corrales GLimonta-Fernandez MPimentel-Vazquez EVazquez-Arteaga AFigueroa-Garcia IGuillen GCalderin-Marin OPinera-Martinez MGonzalez-Formental HCoizeau-Rodriguez EfalseSafety 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.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 <5% of vaccinees. Main immunogenicity success endpoints were a ≥4-fold anti-RBD IgG seroconversion or a ≥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 eve2024-01-01T00:00:00Z2024 Sep2025-04-18T15:56:52.202Z2025-04-07T02:52:10.281ZS-EPMC114354583934003110.3390/vaccines12091001