Investigational RSV Vaccine Receives NDA, Will Begin Clinical Trials

This week, RNAimmune was granted an Investigational New Drug Application (NDA) from the FDA to begin human clinical trial for its mRNA-Based respiratory syncytial virus (RSV) vaccine, RV-1770.

“The IND clearance from the FDA represents a significant leap forward in our mission to provide a safe and effective solution against RSV infection and its profound impact on human health," stated Dong Shen, MD, PhD, president and CEO of RNAimmune. "As we embark on clinical trials aimed at assessing the safety and efficacy of RV-1770, this achievement underscores the potential of RNAimmune's mRNA technology platform in the battle against RSV and the prevention of associated respiratory diseases.”

The company is planning to begin its phase 1 clinical study to assess the safety and tolerance of RV-1770, a combination of an mRNA-based vaccine with a proprietary lipid nanoparticle formulation, aimed at preventing RSV infection in adults. Healthy volunteers between the ages of 18–49 and an older adult group aged 60–79 will receive a single dose of RV-1770 intramuscularly, using one of three dosage levels: 50 μg, 100 μg, or 200 μg.

The study plans to recruit a total of 162 participants divided into two cohorts of younger and older adults with 81 each. All participants will undergo a 12-month post-vaccination monitoring for evaluation of RV-1770's safety and immunogenicity.

RNAimmune is a subsidiary for Sirnaomics and is developing mRNA-based vaccines and therapeutics. With its global headquarters in Germantown, Maryland and in China, the company aims to address unmet medical needs by harnessing messenger RNA technology to create innovative solutions for infectious diseases, cancer, and other health challenges