{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12(9)"],"submitter":["Lemos-Perez G"],"pubmed_abstract":["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 eve"],"journal":["Vaccines"],"pagination":["1001"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11435458"],"repository":["biostudies-literature"],"pubmed_title":["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."],"pmcid":["PMC11435458"],"pubmed_authors":["Martinez-Diaz E","Uranga-Pina R","Avila-Diaz L","Martinez-Rosales R","Gomez-Vazquez MM","Barrese-Perez Y","Ayala-Avila M","Chacon-Quintero Y","Chavez-Valdes S","Lemos-Perez G","Avila-Albuerne Y","Freyre-Corrales G","Limonta-Fernandez M","Pimentel-Vazquez E","Vazquez-Arteaga A","Figueroa-Garcia I","Guillen G","Calderin-Marin O","Pinera-Martinez M","Gonzalez-Formental H","Coizeau-Rodriguez E"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"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 eve","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Sep","modification":"2025-04-18T15:56:52.202Z","creation":"2025-04-07T02:52:10.281Z"},"accession":"S-EPMC11435458","cross_references":{"pubmed":["39340031"],"doi":["10.3390/vaccines12091001"]}}