Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults

Karina A. Pasquevich (), Lorena M. Coria, Ana Ceballos, Bianca Mazzitelli, Juan Manuel Rodriguez, Agostina Demaría, Celeste Pueblas Castro, Laura Bruno, Lucas Saposnik, Melina Salvatori, Augusto Varese, Soledad González, Veronica V. González Martínez, Jorge Geffner, Diego Álvarez, Ethel Feleder, Karina Halabe, Pablo E. Perez Lera, Federico Montes Oca, Julio C. Vega, Mónica Lombardo, Gustavo A. Yerino, Juan Fló and Juliana Cassataro ()
Additional contact information
Karina A. Pasquevich: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Lorena M. Coria: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Ana Ceballos: Facultad de Medicina UBA
Bianca Mazzitelli: Facultad de Medicina UBA
Juan Manuel Rodriguez: Fundación Pablo Cassará - Unidad de I + D de Biofármacos
Agostina Demaría: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Celeste Pueblas Castro: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Laura Bruno: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Lucas Saposnik: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Melina Salvatori: Facultad de Medicina UBA
Augusto Varese: Facultad de Medicina UBA
Soledad González: Ministerio de Salud de la Provincia de Buenos Aires
Veronica V. González Martínez: Ministerio de Salud de la Provincia de Buenos Aires
Jorge Geffner: Facultad de Medicina UBA
Diego Álvarez: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
Ethel Feleder: Ciudad Autónoma de Buenos Aires
Karina Halabe: Ciudad Autónoma de Buenos Aires
Pablo E. Perez Lera: Ciudad Autónoma de Buenos Aires
Federico Montes Oca: Laboratorio Pablo Cassará – Unidad de I + D de Biofármacos
Julio C. Vega: Laboratorio Pablo Cassará – Unidad de I + D de Biofármacos
Mónica Lombardo: Nobeltri
Gustavo A. Yerino: Ciudad Autónoma de Buenos Aires
Juan Fló: Laboratorio Pablo Cassará – Unidad de I + D de Biofármacos
Juliana Cassataro: Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)

Nature Communications, 2023, vol. 14, issue 1, 1-12

Abstract: Abstract A Gamma Variant RBD-based aluminum hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18-55 years old) with a complete COVID-19-primary vaccine scheme were assigned to receive two intramuscular doses of either a low-dose or a high-dose of ARVAC CG. The primary endpoint was safety. The secondary objective was humoral immunogenicity. Cellular immune responses were studied as an exploratory objective. The trial was prospectively registered in PRIISA.BA (Registration Code 6564) and ANMAT and retrospectively registered in ClinicalTrials.gov (NCT05656508). Samples from participants of a surveillance strategy implemented by the Ministry of Health of the Province of Buenos Aires that were boosted with BNT162b2 were also analyzed to compare with the booster effect of ARVAC CG. ARVAC CG exhibits a satisfactory safety profile, a robust and broad booster response of neutralizing antibodies against the Ancestral strain of SARS-CoV-2 and the Gamma, Delta, Omicron BA.1 and Omicron BA.5 variants of concern and a booster effect on T cell immunity in individuals previously immunized with different COVID-19 vaccine platforms.

Date: 2023
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DOI: 10.1038/s41467-023-40272-3

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