A self-amplifying RNA RSV prefusion-F vaccine elicits potent immunity in pre-exposed and naïve non-human primates

Aneesh Vijayan (), Ronald Vogels, Rachel Groppo, Yi Jin, Selina Khan, Mirjam Kampen, Sytze Jorritsma, Satish Boedhoe, Miranda Baert, Harry Diepen, Harmjan Kuipers, Jan Serroyen, Jorge Reyes- Valle, Ann Broman, Lannie Nguyen, Sayoni Ray, Bader Jarai, Jayant Arora, Michelle Lifton, Benjamin Mildenberg, Georgeanna Morton, Sampa Santra, Tamar R. Grossman, Hanneke Schuitemaker, Jerome Custers and Roland Zahn ()
Additional contact information
Aneesh Vijayan: Janssen Vaccines and Prevention B.V.
Ronald Vogels: Janssen Vaccines and Prevention B.V.
Rachel Groppo: Johnson & Johnson Innovative Medicine
Yi Jin: Johnson & Johnson Innovative Medicine
Selina Khan: Janssen Vaccines and Prevention B.V.
Mirjam Kampen: Janssen Vaccines and Prevention B.V.
Sytze Jorritsma: Janssen Vaccines and Prevention B.V.
Satish Boedhoe: Janssen Vaccines and Prevention B.V.
Miranda Baert: Janssen Vaccines and Prevention B.V.
Harry Diepen: Janssen Vaccines and Prevention B.V.
Harmjan Kuipers: Janssen Vaccines and Prevention B.V.
Jan Serroyen: Janssen Vaccines and Prevention B.V.
Jorge Reyes- Valle: Johnson & Johnson Innovative Medicine
Ann Broman: Johnson & Johnson Innovative Medicine
Lannie Nguyen: Johnson & Johnson Innovative Medicine
Sayoni Ray: Johnson & Johnson Innovative Medicine
Bader Jarai: Johnson & Johnson Innovative Medicine
Jayant Arora: Johnson & Johnson Innovative Medicine
Michelle Lifton: Harvard Medical School.
Benjamin Mildenberg: Harvard Medical School.
Georgeanna Morton: Harvard Medical School.
Sampa Santra: Harvard Medical School.
Tamar R. Grossman: Johnson & Johnson Innovative Medicine
Hanneke Schuitemaker: Janssen Vaccines and Prevention B.V.
Jerome Custers: Janssen Vaccines and Prevention B.V.
Roland Zahn: Janssen Vaccines and Prevention B.V.

Nature Communications, 2024, vol. 15, issue 1, 1-14

Abstract: Abstract Newly approved subunit and mRNA vaccines for respiratory syncytial virus (RSV) demonstrate effectiveness in preventing severe disease, with protection exceeding 80% primarily through the generation of antibodies. An alternative vaccine platform called self-amplifying RNA (saRNA) holds promise in eliciting humoral and cellular immune responses. We evaluate the immunogenicity of a lipid nanoparticle (LNP)-formulated saRNA vaccine called SMARRT.RSV.preF, encoding a stabilized form of the RSV fusion protein, in female mice and in non-human primates (NHPs) that are either RSV-naïve or previously infected. Intramuscular vaccination with SMARRT.RSV.preF vaccine induces RSV neutralizing antibodies and cellular responses in naïve mice and NHPs. Importantly, a single dose of the vaccine in RSV pre-exposed NHPs elicits a dose-dependent anamnestic humoral immune response comparable to a subunit RSV preF vaccine. Notably, SMARRT.RSV.preF immunization significantly increases polyfunctional RSV.F specific memory CD4+ and CD8+ T-cells compared to RSV.preF protein vaccine. Twenty-four hours post immunization with SMARRT.RSV.preF, there is a dose-dependent increase in the systemic levels of inflammatory and chemotactic cytokines associated with the type I interferon response in NHPs, which is not observed with the protein vaccine. We identify a cluster of analytes including IL-15, TNFα, CCL4, and CXCL10, whose levels are significantly correlated with each other after SMARRT.RSV.preF immunization. These findings suggest saRNA vaccines have the potential to be developed as a prophylactic RSV vaccine based on innate, cellular, and humoral immune profiles they elicit.

Date: 2024
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DOI: 10.1038/s41467-024-54289-9

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