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 Enrique Guillén-Nieto

doi:10.20944/preprints202406.0703.v1

How to cite: Lemos-Pérez, G.; Barrese-Pérez, Y.; Chacón-Quintero, Y.; Uranga-Piña, R.; Avila-Albuerne, Y.; Figueroa-García, I.; Calderín-Marín, O.; Gómez-Vázquez, M. M.; Piñera-Martínez, M.; Chávez-Valdés, S.; Martínez-Rosales, R.; Ávila-Díaz, L.; Vázquez-Arteaga, A.; González-Formental, H.; Freyre-Corrales, G.; Coizeau-Rodríguez, E.; Limonta-Fernández, M.; Ayala-Avila, M.; Martínez-Díaz, E.; Pimentel-Vazquez, E.; Guillén-Nieto, G. E. 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. Preprints 2024, 2024060703. https://doi.org/10.20944/preprints202406.0703.v1 Lemos-Pérez, G.; Barrese-Pérez, Y.; Chacón-Quintero, Y.; Uranga-Piña, R.; Avila-Albuerne, Y.; Figueroa-García, I.; Calderín-Marín, O.; Gómez-Vázquez, M. M.; Piñera-Martínez, M.; Chávez-Valdés, S.; Martínez-Rosales, R.; Ávila-Díaz, L.; Vázquez-Arteaga, A.; González-Formental, H.; Freyre-Corrales, G.; Coizeau-Rodríguez, E.; Limonta-Fernández, M.; Ayala-Avila, M.; Martínez-Díaz, E.; Pimentel-Vazquez, E.; Guillén-Nieto, G. E. 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. Preprints 2024, 2024060703. https://doi.org/10.20944/preprints202406.0703.v1

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.

Keywords

Subject

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Not displayed online.

Please leave your comment to this article below.

Mathematical equations can be typed in either LaTeX formats \\[ ... \\] or $$ ... $$, or MathML format <math> ... </math>. Try the LaTeX or MathML example.

Type equation:

Preview:

Copy equation into message below

Close menu

Please click a symbol to insert it into the message box below:

Please enter the link here:

Optionally, you can enter text that should appear as linked text:

Copy link into message below

Please enter or paste the URL to the image here (please only use links to jpg/jpeg, png and gif images):

Copy image into message below

Type author name or keywords to filter the list of references in this group (you can add a new citation under Bibliography):

No existing citations in Discussion Group

Wikify editor is a simple editor for wiki-style mark-up. It was written by MDPI for Sciforum in 2014. The rendering of the mark-up is based on Wiky.php with some tweaks. Rendering of mathematical equations is done with MathJax. Please send us a message for support or for reporting bugs.

Please declare any conflicts of interest you may have with this paper, financial or otherwise.

I do not have a conflict of interest

I would like to declare a conflict of interest

Display my name on the website

Captcha

Renew

I accept the following conditions:

Comments must follow the standards of professional discourse and should focus on the scientific content of the article. Insulting or offensive language, personal attacks and off-topic remarks will not be permitted. Comments must be written in English. Preprints reserves the right to remove comments without notice. Readers who post comments are obliged to declare any competing interests, financial or otherwise.

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

Abstract

Keywords

Subject

Comments (0)