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 DOI Open Access
Gilda Lemos,

Yinet Barrese-Pérez,

Yahima Chacón-Quintero

et al.

Published: June 11, 2024

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 Abdala) in boosting immunity convalescent adults after receiving one dose either vaccine. The main outcome severe vaccination adverse events occurring <5% vaccinees. Main success endpoints were ≥4-fold anti-RBD IgG seroconversion or ≥20% increase ACE2-RBD inhibitory antibodies >55% vaccinees Phase 1 >70% 2. Neutralizing antibody titers against SARS-CoV-2 variants evaluated. Both safe; no deaths occurred. Mild intensity the most frequent (>73%); headache predominated for both vaccines. responders 83.3% (p = 0.0018) Abdala. Mambisa showed similar results. 2 88.6% Abdala <0.0001) 74.2% 0.0412). In phases, titers, inhibition percentages neutralizing increased significantly booster dose. safe their surpassed study endpoints.

Language: Английский

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 DOI Open Access
Gilda Lemos,

Yinet Barrese-Pérez,

Yahima Chacón-Quintero

et al.

Published: June 11, 2024

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 Abdala) in boosting immunity convalescent adults after receiving one dose either vaccine. The main outcome severe vaccination adverse events occurring <5% vaccinees. Main success endpoints were ≥4-fold anti-RBD IgG seroconversion or ≥20% increase ACE2-RBD inhibitory antibodies >55% vaccinees Phase 1 >70% 2. Neutralizing antibody titers against SARS-CoV-2 variants evaluated. Both safe; no deaths occurred. Mild intensity the most frequent (>73%); headache predominated for both vaccines. responders 83.3% (p = 0.0018) Abdala. Mambisa showed similar results. 2 88.6% Abdala <0.0001) 74.2% 0.0412). In phases, titers, inhibition percentages neutralizing increased significantly booster dose. safe their surpassed study endpoints.

Language: Английский

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