SARS-CoV-2-derived RNA replicons as safe and effective vaccines

M Marta Villarejo-Torres (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) I Iván Nombela-Diaz (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) D Diego Muñóz-Santos (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) M Mercedes Ruiz-Yuste (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) A Ana Marchena-Pasero (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) M María A. Rueda-Huélamo (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) J Jorge Ripoll-Gómez (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) P Pedro J. Sánchez-Cordón (Pathology Department, Centro de Investigaciones en Salud Animal, Instituto de Investigación y Tecnología Agraria y Alimentaria (INIA-CSIC)) L Laura Fernandez del Ama (Pathology Department, Centro de Investigaciones en Salud Animal, Instituto de Investigación y Tecnología Agraria y Alimentaria (INIA-CSIC)) J José M. Honrubia (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) J Javier Gutiérrez-Álvarez (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) J Jesús Hurtado-Tamayo (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) R Ricardo Requena-Platek (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) M María Guzmán (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) J Jose M. Casasnovas (Department of Macromolecular Structures, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) J Juan F. García-Arriaza (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) P Patricia Perez (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) B Beatriz Martin-Jouve (Electron Microscopy Service, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) T Tania Matamoros (Electron Microscopy Facility, Molecular Biology Center (CBMSO-CSIC), Campus Universidad Autónoma de Madrid) B Belén Pintado (Transgenesis and Gene Editing Unit, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) S Stanley Perlman I Isabel Sola (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) S Sonia Zuñiga (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid) L Luis Enjuanes (Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid)

Abstract

A collection of RNA replicons (RRs) derived from severe acute respiratory syndrome 2 (SARS-CoV-2) for use in vaccine design was constructed by genetic engineering using bacterial artificial chromosomes. A replicon, which was deleted in six genes (3a, 3c, E, 6, 7a, and 7b) was selected. Cells infected with the RR vaccine candidate led to the formation of virus-like particles that, due to the failure of being secreted, increase vaccine safety, in contrast to the wild type virions. The replicon maintained the production of RNAs encoding at least proteins S, M, and N for several days. Intranasal immunization with the RR of transgenic mice, expressing human ACE2, elicited respiratory mucosal immunity. Immunization protected against challenge with SARS-CoV-2, inducing IgG, IgM, and IgA antibodies to the spike (S) protein, the receptor binding domain, N and M proteins, and cellular immune responses (CD4 + , CD8 + , and long-term memory T cells). Coinfection of cells with the RR vaccine and a full-length SARS-CoV-2 led to a significant inhibition of replication of full-length virus, increasing the safety of the RR vaccine. The RR vaccine induced a minor inflammatory reaction in the absence of major side effects and was stable at different temperatures. An updated RR expressing XBB.1.5 S protein elicited neutralizing antibodies against the homologous virus and provided full protection against recent SARS-CoV-2 variants.

Article Details

Volume / Issue Vol. 122, Issue 39
Published September 30, 2025
ISSN 0027-8424
Publisher National Academy of Sciences

Authors (24)

M

Marta Villarejo-Torres

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

I

Iván Nombela-Diaz

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

D

Diego Muñóz-Santos

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

M

Mercedes Ruiz-Yuste

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

A

Ana Marchena-Pasero

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

M

María A. Rueda-Huélamo

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

J

Jorge Ripoll-Gómez

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

P

Pedro J. Sánchez-Cordón

Pathology Department, Centro de Investigaciones en Salud Animal, Instituto de Investigación y Tecnología Agraria y Alimentaria (INIA-CSIC)

L

Laura Fernandez del Ama

Pathology Department, Centro de Investigaciones en Salud Animal, Instituto de Investigación y Tecnología Agraria y Alimentaria (INIA-CSIC)

J

José M. Honrubia

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

J

Javier Gutiérrez-Álvarez

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

J

Jesús Hurtado-Tamayo

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

R

Ricardo Requena-Platek

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

M

María Guzmán

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

J

Jose M. Casasnovas

Department of Macromolecular Structures, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

J

Juan F. García-Arriaza

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

P

Patricia Perez

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

B

Beatriz Martin-Jouve

Electron Microscopy Service, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

T

Tania Matamoros

Electron Microscopy Facility, Molecular Biology Center (CBMSO-CSIC), Campus Universidad Autónoma de Madrid

B

Belén Pintado

Transgenesis and Gene Editing Unit, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

S

Stanley Perlman

I

Isabel Sola

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

S

Sonia Zuñiga

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid

L

Luis Enjuanes

Department of Molecular and Cell Biology, National Center of Biotechnology (CNB-CSIC), Darwin 3, Campus Universidad Autónoma de Madrid