Sirnaomics subsidiary RNAimmune has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to commence a Phase I trial of RV-1730 SARS-CoV-2 vaccine booster.
The planned trial will assess the safety and prophylaxis efficacy of RV-1730 against SARS-CoV-2 infection in people who were earlier immunised with other mRNA-based vaccines for Covid-19.
During the trial, RV-1730 will be given as a single booster dose to healthy adults who previously received either the Pfizer-BioNTech or Moderna Covid-19 mRNA vaccine.
Participants aged 18–55 years will be included in the trial.
They will receive one of the three RV-1730 doses at 15µg, 30µg or 100µg accordingly.
The trial expects to include a total of 45 subjects in three different cohorts in the US.
Following enrolment, all subjects will be checked 12 months after vaccination for evaluating RV-1730’s safety and immunogenicity.
RNAimmune founder and president Dong Shen said: “The IND clearance from the FDA will allow us to investigate RV-1730 as an effective vaccine booster with the potential to provide continued protection against Covid-19.
“This study is expected to provide preliminary data on the safety, tolerability, and immunogenicity of RV-1730’s technology when using a vaccine construct that targets the SARS-CoV-2 variants.
“With further research, RNAimmune’s vaccine candidate may be the focus of future studies with more contemporary variant constructs or multivalent constructs like Omicron, XBB, and other Covid-19 variants.”
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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