mRNA vaccine to prevent HTLV-1 and related leukemia

Project 1: Development of an HTLV-1 mRNA vaccine

['FUNDING_P01'] · WASHINGTON UNIVERSITY · NIH-11198130

This project develops an mRNA vaccine that trains the immune system to target HTLV-1 for people at risk of HTLV-1 infection or who carry the virus linked to adult T‑cell leukemia/lymphoma and HAM/TSP.

Quick facts

Phase['FUNDING_P01']
Study typeNih_funding
SexAll
SponsorWASHINGTON UNIVERSITY (nih funded)
Locations1 site (SAINT LOUIS, UNITED STATES)
Trial IDNIH-11198130 on ClinicalTrials.gov

What this research studies

If you're affected by HTLV-1 or at risk, this project is developing an mRNA vaccine meant to teach your immune system to recognize HTLV-1 proteins. Researchers are designing mRNA that encodes the virus's envelope (Env) protein and are building on prior work identifying another viral target, Hbz. The vaccine mRNA is packaged in lipid nanoparticles and will first be tested in laboratory and animal models to measure immune responses and safety, using shared viral-vector and animal cores. If preclinical results are promising, the team plans to advance the approach toward early human testing at Washington University and collaborating centers.

Who could benefit from this research

Good fit: Ideal candidates would be people at high risk of HTLV-1 exposure or known HTLV-1 carriers who might benefit from a preventive or therapeutic vaccine.

Not a fit: People without HTLV-1 exposure, those with very advanced, treatment-refractory ATLL, or individuals who cannot mount an immune response (severely immunocompromised) may not benefit from a vaccine approach.

Why it matters

Potential benefit: If successful, the vaccine could prevent HTLV-1 infection or lower the risk of developing HTLV-1–related diseases like adult T‑cell leukemia/lymphoma (ATLL) and HAM/TSP.

How similar studies have performed: mRNA vaccine platforms have shown strong success for other viruses such as SARS-CoV-2, but HTLV-1–specific vaccines are largely novel and have not been tested in humans to date.

Where this research is happening

SAINT LOUIS, 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.