How muscle-targeted self-replicating RNA vaccines trigger immunity

Immunological mechanism of muscle-localizing self-replicating RNA vaccines

['FUNDING_R01'] · HDT BIO CORPORATION · NIH-11192826

This project looks at how self-amplifying RNA vaccines delivered to muscle activate immune responses to protect people from respiratory viruses like COVID-19, RSV, and influenza.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorHDT BIO CORPORATION (nih funded)
Locations1 site (SEATTLE, UNITED STATES)
Trial IDNIH-11192826 on ClinicalTrials.gov

What this research studies

Researchers are developing vaccines that use self-replicating RNA delivered with a muscle-targeting carrier called LION so high doses can be given without widespread inflammation. From your perspective, the team wants to know which immune cells that enter the muscle after injection make the vaccine work and which signals reduce vaccine protein production or cause side effects. The work uses laboratory experiments and animal models to track transgene expression, type I interferon signaling, and CD11b+ immune cells after intramuscular vaccination. Findings are intended to guide safer, stronger multivalent RNA vaccines that could later be tested in people.

Who could benefit from this research

Good fit: People concerned about or at risk for respiratory viruses (SARS-CoV-2, RSV, influenza) or healthy volunteers interested in future vaccine trials or sample donation would be relevant candidates.

Not a fit: Patients with no risk or concern for these respiratory viruses, or those unable to receive intramuscular vaccines, are less likely to benefit directly from this work.

Why it matters

Potential benefit: If successful, this could enable safer and more effective multivalent RNA vaccines that protect against multiple respiratory viruses with fewer side effects.

How similar studies have performed: Related self-amplifying RNA vaccines delivered with muscle-targeting carriers have shown promising immune responses and safety in animal studies, though human data remain limited.

Where this research is happening

SEATTLE, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.