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.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
