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

Author

Listed:
  • Karina A. Pasquevich

    (Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
    Universidad Nacional de San Martín)

  • Lorena M. Coria

    (Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
    Universidad Nacional de San Martín)

  • 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)
    Universidad Nacional de San Martín)

  • Celeste Pueblas Castro

    (Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
    Universidad Nacional de San Martín)

  • Laura Bruno

    (Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
    Universidad Nacional de San Martín)

  • Lucas Saposnik

    (Universidad Nacional de San Martín (UNSAM) – Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET)
    Universidad Nacional de San Martín)

  • 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)
    Universidad Nacional de San Martín)

  • 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)
    Universidad Nacional de San Martín)

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.

Suggested Citation

  • Karina A. Pasquevich & Lorena M. Coria & Ana Ceballos & Bianca Mazzitelli & Juan Manuel Rodriguez & Agostina Demaría & Celeste Pueblas Castro & Laura Bruno & Lucas Saposnik & Melina Salvatori & August, 2023. "Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults," Nature Communications, Nature, vol. 14(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:14:y:2023:i:1:d:10.1038_s41467-023-40272-3
    DOI: 10.1038/s41467-023-40272-3
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    References listed on IDEAS

    as
    1. Sandile Cele & Laurelle Jackson & David S. Khoury & Khadija Khan & Thandeka Moyo-Gwete & Houriiyah Tegally & James Emmanuel San & Deborah Cromer & Cathrine Scheepers & Daniel G. Amoako & Farina Karim , 2022. "Omicron extensively but incompletely escapes Pfizer BNT162b2 neutralization," Nature, Nature, vol. 602(7898), pages 654-656, February.
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    1. Lorena M. Coria & Juan Manuel Rodriguez & Agostina Demaria & Laura A. Bruno & Mayra Rios Medrano & Celeste Pueblas Castro & Eliana F. Castro & Sabrina A. Del Priore & Andres C. Hernando Insua & Ingrid, 2024. "A Gamma-adapted subunit vaccine induces broadly neutralizing antibodies against SARS-CoV-2 variants and protects mice from infection," Nature Communications, Nature, vol. 15(1), pages 1-14, December.

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