ARVAC-A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine

Summary

The goals of this clinical trial are: 1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. 2. Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2 virus The main questions to be answered are: 1. Phase 2: 1. What si the immune response after one dose of vaccine? 2. What is the safety and tolerability profile of this vaccine? 2. Phase 3 : 1. What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants. 2. What is the safety and tolerability profile of this vaccine? In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design. In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.

Timeline

Start

2023-02-06

Primary completion

2023-08-22

Completion

2023-12-07

Outcome

Met primary endpoint

paper In participants aged 18-60 years, all versions met the primary endpoint; in those over 60 years old, ARVACOmicron and ARVACBivalent met this endpoint. PMID 40179522 ↗

paper All vaccine versions significantly increased seroconversion rates to SARS-CoV-2 variants compared to placebo. PMID 40179522 ↗

Publications

• Perez Marc G, Coria LM, Ceballos A, Rodriguez JM, Lombardo ME, Bruno L, Paez Cordoba F, Fascetto Cassero CG, Salvatori M, Rios Medrano M, Fulgenzi F, Alzogaray MF, Mykietiuk A, Uriarte IL, Itcovici N, Smith Casabella T, Corral G, Bruno M, Roldan O, Nunez SA, Cahn F, Yerino GA, Bianchi A, Braem V, Christmann A, Corradetti S, Darraidou MC, Di Nunzio L, Estrada T, Lopez Castelo R, Marchionatti C, Pitocco L, Trias Uriarte V, Wood C, Zadoff R, Bues F, Garrido RM, Montomoli E, Manenti A; Laboratorio Pablo Cassara group for ARVAC; Demaria A, Prado L, Pueblas Castro C, Saposnik L, Geffner J, Montes de Oca F, Vega JC, Flo J, Bonvehi P, Cassara J, Pasquevich KA, Cassataro J. 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. Vaccine. 2025 Apr 30;54:127045. doi: 10.1016/j.vaccine.2025.127045. Epub 2025 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bivalent RBD-based ARVAC-CG vaccine	Vaccine	25 ug	Intramuscular
Subject	Gamma Variant RBD-based ARVAC-CG vaccine	Vaccine	50 ug	Intramuscular
Subject	Omicron Variant RBD-based ARVAC-CG vaccine	Vaccine	50 ug	Intramuscular

Indications

No indication recorded.