Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial

A randomized, placebo-controlled, crossover, double-blind, phase II/III study was conducted to evaluate the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the SARS-CoV-2 spike protein receptor binding domain in three versions: ARVAC<sub>Gamma</sub>, ARVAC<sub>Omicron</sub>, and ARVAC<sub>Bivalent</sub> in adults with ≤3 previous SARS-CoV-2 booster doses. Primary endpoint was seroconversion rate of neutralizing antibodies compared to placebo and to a > 75 % seroconversion rate to vaccine antigen homologous variants. All vaccine versions significantly increased seroconversion rates to SARS-CoV-2 variants compared to placebo. In participants aged 18-60 years, all versions met the primary endpoint; in those over 60 years old, ARVAC<sub>Omicron</sub> and ARVAC<sub>Bivalent</sub> met this endpoint. No vaccine-related serious adverse events were recorded, and most adverse events were mild. Plasma levels of anti-spike-specific IgG and anti-S1-specific IgA in saliva increased in participants receiving any vaccine. The increase in plasma neutralizing antibodies induced by the vaccine was independent of the number of previous booster doses (0, 1 or 2), the primary vaccine platform (adenovirus, single-dose adenovirus, mRNA, inactivated virus, heterologous vaccination, and virus-like particle [VLP]) and the history of previous COVID-19. The neutralizing Ab response induced by the vaccine in healthy participants was similar to that triggered in participants with underlying medical conditions associated with an increased risk of severe COVID-19. ARVAC<sub>Bivalent</sub> induced high seroconversion rates (>90 %) against multiple variants and was superior to other ARVAC-versions. It increased neutralizing antibodies against SARS-CoV-2 variants (Ancestral, Gamma, Omicron, XBB and JN.1) and SARS-CoV-1. (NCT05752201).

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Publication Details

Journal
Vaccine
Published
2025-04-01
DOI
https://doi.org/10.1016/j.vaccine.2025.127045
Citations
2
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
2.79
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article

Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial

Virginia Braem, Pablo Bonvehí, Miriam Bruno, Ana Ceballos et al.
2 citations
Vaccine
SARS-CoV-2 and COVID-19 Research
2.79
article

Immunogenicity and safety of monovalent and bivalent SARS-CoV-2 variant adapted RBD-based protein booster vaccines in adults previously immunized with different vaccine platforms: A phase II/III, randomized clinical trial

Virginia Braem, Pablo Bonvehí, Miriam Bruno, Ana Ceballos, Lorena M. Coria, Rosa M. Urbanos‐Garrido, Juliana Cassataro, María Fernanda Alzogaray, Cristian Wood, Melina Salvatori, Alejandra Bianchi, Juan Fló, Lucas Saposnik, Julio C. Vega, Sebastián A Núñez, Federico Páez Córdoba, Karina A. Pasquevich, Nicolás Itcovici, Jorge Geffner, Gonzalo Corral, Lineia Prado, Alessandro Manenti, Juan M. Corchado, Mónica Lombardo, Celeste Pueblas Castro, Mayra Rios Medrano, Florencia Cahn, Analía Mykietiuk, Emanuele Montomoli, Ignacio Leandro Uriarte, Federico Montes de, Rocío López Castelo, G. Yerino, Fabiana Fulgenzi, Agostina Demaría, Oscar Roldán, Carla Graciela Marchionatti, Jorge Cassará, Clara G Fascetto Cassero, Martín Claudio Darraidou, Tomás Smith Casabella, Lucila Pitocco, Virgina Macarena Trias Uriarte, Gonzalo Pérez Marc, Romina Zadoff, Florencia Bues, Laura Bruno, Santiago Corradetti, Analía Christmann, Tatiana Estrada, Lucila Di Nunzio
article en
2 citations

Abstract

A randomized, placebo-controlled, crossover, double-blind, phase II/III study was conducted to evaluate the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the SARS-CoV-2 spike protein receptor binding domain in three versions: ARVAC<sub>Gamma</sub>, ARVAC<sub>Omicron</sub>, and ARVAC<sub>Bivalent</sub> in adults with ≤3 previous SARS-CoV-2 booster doses. Primary endpoint was seroconversion rate of neutralizing antibodies compared to placebo and to a > 75 % seroconversion rate to vaccine antigen homologous variants. All vaccine versions significantly increased seroconversion rates to SARS-CoV-2 variants compared to placebo. In participants aged 18-60 years, all versions met the primary endpoint; in those over 60 years old, ARVAC<sub>Omicron</sub> and ARVAC<sub>Bivalent</sub> met this endpoint. No vaccine-related serious adverse events were recorded, and most adverse events were mild. Plasma levels of anti-spike-specific IgG and anti-S1-specific IgA in saliva increased in participants receiving any vaccine. The increase in plasma neutralizing antibodies induced by the vaccine was independent of the number of previous booster doses (0, 1 or 2), the primary vaccine platform (adenovirus, single-dose adenovirus, mRNA, inactivated virus, heterologous vaccination, and virus-like particle [VLP]) and the history of previous COVID-19. The neutralizing Ab response induced by the vaccine in healthy participants was similar to that triggered in participants with underlying medical conditions associated with an increased risk of severe COVID-19. ARVAC<sub>Bivalent</sub> induced high seroconversion rates (>90 %) against multiple variants and was superior to other ARVAC-versions. It increased neutralizing antibodies against SARS-CoV-2 variants (Ancestral, Gamma, Omicron, XBB and JN.1) and SARS-CoV-1. (NCT05752201).

VaccineVol. 54
National University of Salta (AR), University of Siena (IT), Universidad del Salvador (AR), Universidad Autónoma de la Ciudad de México (MX), National University of Mar del Plata (AR), National University of General San Martín (AR), Universidad de Buenos Aires (AR), Instituto de Investigaciones Físicas de Mar del Plata (AR), Fundación Huésped (AR), Instituto de Investigaciones Biomédicas en Retrovirus y Sida (AR), Universidad Católica de Salta (AR), Hospital Militar Central (CO), Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (AR), Instituto Médico Platense (AR), VisMederi Research (IT), Fundación Centro de Estudios Infectológicos (AR), Hospital Privado (AR), Centro de Investigaciones Cardiovasculares (AR)
Good health and well-being
Openalex Percentile: Top 11%
SARS-CoV-2 and COVID-19 Research
2.79
DOIOpen Access PDFOpenAlex
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