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Clinical Trial
. 2025 Apr 30:54:127045.
doi: 10.1016/j.vaccine.2025.127045. Epub 2025 Apr 3.

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

Gonzalo Perez Marc  1 , Lorena M Coria  2 , Ana Ceballos  3 , Juan Manuel Rodriguez  4 , Mónica E Lombardo  5 , Laura Bruno  2 , Federico Páez Córdoba  2 , Clara G Fascetto Cassero  2 , Melina Salvatori  3 , Mayra Rios Medrano  2 , Fabiana Fulgenzi  2 , María F Alzogaray  6 , Analía Mykietiuk  6 , Ignacio Leandro Uriarte  7 , Nicolás Itcovici  8 , Tomás Smith Casabella  9 , Gonzalo Corral  10 , Miriam Bruno  11 , Oscar Roldán  12 , Sebastián A Núñez  13 , Florencia Cahn  14 , Gustavo A Yerino  15 , Alejandra Bianchi  16 , Virginia Braem  16 , Analía Christmann  16 , Santiago Corradetti  16 , Martín C Darraidou  16 , Lucila Di Nunzio  16 , Tatiana Estrada  16 , Rocío López Castelo  16 , Carla Marchionatti  16 , Lucila Pitocco  16 , Virgina Trias Uriarte  16 , Cristian Wood  16 , Romina Zadoff  16 , Florencia Bues  17 , Rosa M Garrido  17 , Emanuele Montomoli  18 , Alessandro Manenti  19 ; Laboratorio Pablo Cassará group for ARVAC  4 ; Agostina Demaría  2 , Lineia Prado  2 , Celeste Pueblas Castro  2 , Lucas Saposnik  2 , Jorge Geffner  3 , Federico Montes de Oca  4 , Julio C Vega  4 , Juan Fló  4 , Pablo Bonvehí  20 , Jorge Cassará  4 , Karina A Pasquevich  21 , Juliana Cassataro  22
Collaborators, Affiliations
Free article
Clinical Trial

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

Gonzalo Perez Marc et al. Vaccine. .
Free article

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: ARVACGamma, ARVACOmicron, and ARVACBivalent 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, ARVACOmicron and ARVACBivalent 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. ARVACBivalent 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).

Keywords: Booster; Receptor binding domain; Recombinant protein vaccine; SARS-CoV-2; Variant-adapted vaccine, pan-sarbecovirus vaccine.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Juan Manuel Rodriguez reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Monica E. Lombardo reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Laboratorio Pablo Cassara group for ARVAC reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Federico Montes de Oca reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Julio C. Vega reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Juan Flo reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Jorge Cassara reports financial support was provided by Laboratorio Pablo Cassará S.R.L. Florencia Bues reports financial support was provided by Nobeltri S.R.L. Rosa M. Garrido reports financial support was provided by Nobeltri S.R.L. Gonzalo Perez Marc reports a relationship with Merck & Co Inc. that includes: funding grants. Gonzalo Perez Marc reports a relationship with Pfizer Inc. that includes: board membership and funding grants. Gonzalo Perez Marc reports a relationship with Sanofi that includes: funding grants. Gonzalo Perez Marc reports a relationship with Moderna Inc. that includes: funding grants. Alejandra Bianchi reports a relationship with Merck & Co Inc. that includes: funding grants. Alejandra Bianchi reports a relationship with Pfizer Inc. that includes: funding grants. Alejandra Bianchi reports a relationship with Sanofi that includes: funding grants. Alejandra Bianchi reports a relationship with Moderna Inc. that includes: funding grants. Virginia Braem reports a relationship with Merck & Co Inc. that includes: funding grants. Virginia Braem reports a relationship with Pfizer Inc. that includes: funding grants. Virginia Braem reports a relationship with Moderna Inc. that includes: funding grants. Virginia Braem reports a relationship with Sanofi that includes: funding grants. Analia Christmann reports a relationship with Merck & Co Inc. that includes: funding grants. Analia Christmann reports a relationship with Pfizer Inc. that includes: funding grants. Analia Christmann reports a relationship with Sanofi that includes: funding grants. Analia Christmann reports a relationship with Moderna Inc. that includes: funding grants. Santiago Corradetti reports a relationship with Merck & Co Inc. that includes: funding grants. Santiago Corradetti reports a relationship with Pfizer that includes: funding grants. Santiago Corradetti reports a relationship with Sanofi that includes: funding grants. Santiago Corradetti reports a relationship with Moderna Inc. that includes: funding grants. Martin C. Darraidou reports a relationship with Merck & Co Inc. that includes: funding grants. Martin C. Darraidou reports a relationship with Pfizer that includes: funding grants. Martin C. Darraidou reports a relationship with Sanofi that includes: funding grants. Martin C. Darraidou reports a relationship with Moderna Inc. that includes: funding grants. Lucila Di Nunzio reports a relationship with Merck & Co Inc. that includes: funding grants. Lucila Di Nunzio reports a relationship with Pfizer that includes: funding grants. Lucila Di Nunzio reports a relationship with Sanofi that includes: funding grants. Lucila Di Nunzio reports a relationship with Moderna Inc. that includes: funding grants. Tatiana Estrada reports a relationship with Merck & Co Inc. that includes: funding grants. Tatiana Estrada reports a relationship with Pfizer that includes: funding grants. Tatiana Estrada reports a relationship with Sanofi that includes: funding grants. Tatiana Estrada reports a relationship with Tatiana Estrada that includes: funding grants. Tatiana Estrada reports a relationship with Moderna Inc. that includes: funding grants. Rocio Lopez Castelo reports a relationship with Merck & Co Inc. that includes: funding grants. Rocio Lopez Castelo reports a relationship with Pfizer that includes: funding grants. Rocio Lopez Castelo reports a relationship with Sanofi that includes: funding grants. Rocio Lopez Castelo reports a relationship with Moderna Inc. that includes: funding grants. Carla Marchionatti reports a relationship with Merck & Co Inc. that includes: funding grants. Carla Marchionatti reports a relationship with Pfizer Inc. that includes: funding grants. Carla Marchionatti reports a relationship with Sanofi that includes: funding grants. Carla Marchionatti reports a relationship with Moderna Inc. that includes: funding grants. Lucila Pitocco reports a relationship with Merck & Co Inc. that includes: funding grants. Lucila Pitocco reports a relationship with Pfizer that includes: funding grants. Lucila Pitocco reports a relationship with Sanofi that includes: funding grants. Lucila Pitocco reports a relationship with Moderna Inc. that includes: funding grants. Virgina Trias Uriarte reports a relationship with Merck & Co Inc. that includes: funding grants. Virgina Trias Uriarte reports a relationship with Pfizer that includes: funding grants. Virgina Trias Uriarte reports a relationship with Sanofi that includes: funding grants. Virgina Trias Uriarte reports a relationship with Moderna Inc. that includes: funding grants. Cristian Wood reports a relationship with Merck & Co Inc. that includes: funding grants. Cristian Wood reports a relationship with Pfizer that includes: funding grants. Cristian Wood reports a relationship with Sanofi that includes: funding grants. Moderna reports a relationship with Cristian Wood that includes: funding grants. Romina Zadoff reports a relationship with Merck & Co Inc. that includes: funding grants. Romina Zadoff reports a relationship with Pfizer that includes: funding grants. Romina Zadoff reports a relationship with Sanofi that includes: funding grants. Romina Zadoff reports a relationship with Moderna Inc. that includes: funding grants. Pablo Bonvehi reports a relationship with Sinopharm that includes: funding grants. Pablo Bonvehi reports a relationship with Janssen Pharmaceuticals Inc. that includes: funding grants. Maria F. Alzogaray reports a relationship with AstraZeneca that includes: funding grants. Maria F. Alzogaray reports a relationship with Pfizer that includes: funding grants. Maria F. Alzogaray reports a relationship with Dompé pharmaceutical that includes: funding grants. Maria F. Alzogaray reports a relationship with Red Insight that includes: funding grants. Nicolas Itcovici reports a relationship with GSK that includes: funding grants. Nicolas Itcovici reports a relationship with Celcuity, Inc. that includes: funding grants. Nicolas Itcovici reports a relationship with Novartis that includes: funding grants. Nicolas Itcovici reports a relationship with Genentech that includes: funding grants. Nicolas Itcovici reports a relationship with AstraZeneca that includes: funding grants. Nicolas Itcovici reports a relationship with MSD that includes: funding grants. Nicolas Itcovici reports a relationship with Chiesi that includes: funding grants. Sebastian A. Nunez reports a relationship with GSK that includes: funding grants. Sebastian A. Nunez reports a relationship with AstraZeneca that includes: funding grants. Sebastian A. Nunez reports a relationship with Sanofi Aventis that includes: funding grants. Sebastian A. Nunez reports a relationship with Eli Lilly that includes: funding grants. Sebastian A. Nunez reports a relationship with National Institute of Allergy and Infectious Diseases that includes: funding grants. Sebastian A. Nunez reports a relationship with Atea Pharmaceuticals that includes: funding grants. Oscar Roldan reports a relationship with Merck that includes: funding grants. Pablo Bonvehi reports a relationship with Moderna that includes: board membership. Pablo Bonvehi reports a relationship with Raffo Laboratories that includes: board membership. Gonzalo Perez Marc reports a relationship with Enanta Pharmaceuticals Inc. that includes: board membership. Sebastian A. Nunez reports a relationship with GSK that includes: travel reimbursement. Sebastian A. Nunez reports a relationship with MSD that includes: travel reimbursement. Sebastian A. Nunez reports a relationship with Sanofi that includes: travel reimbursement. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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