Immune responses to AAV-FVIII gene therapy

Mechanisms of Innate and Adaptive Immune Responses to AAV-FVIII Gene Transfer

NIH-funded research Indiana University Indianapolis · NIH-11325363

Working to reduce immune reactions that shorten the benefits of AAV-based gene therapy for people with hemophilia A.

Quick facts

Grant typeP01 program project
Study typeNIH-funded research
Funding institutionIndiana University Indianapolis NIH-funded
Lab location1 site (Indianapolis, United States)
Project IDNIH-11325363 on NIH RePORTER

What this research studies

This project looks at why liver-directed AAV-FVIII gene therapy can lose effectiveness over time and cause liver inflammation. The team studies how the body makes antibodies and T-cell responses against the AAV vector and the FVIII protein using laboratory experiments, animal models, and samples from clinical trials. They aim to identify mechanisms that drive loss of factor VIII expression and liver toxicity and to test strategies to prevent those immune reactions. Findings will be used to guide safer, more durable gene therapy approaches for people with hemophilia A.

Who could benefit from this research

Good fit: People with hemophilia A (factor VIII deficiency) who are considering, enrolled in, or providing samples for AAV-FVIII gene therapy research would be the ideal candidates for related clinical or sample-donation activities.

Not a fit: People without hemophilia A or those who are ineligible for liver-directed AAV therapies (for example because of pre-existing AAV antibodies or significant liver disease) are unlikely to directly benefit from this work.

Why it matters

Potential benefit: Could lead to safer, more durable AAV-FVIII gene therapies that reduce or eliminate the need for regular factor infusions in people with hemophilia A.

How similar studies have performed: Some AAV-FVIII clinical trials have restored factor VIII levels in the short term, but many have shown declining expression over years and immune-related complications remain a key challenge.

Where this research is happening

Indianapolis, 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.
Conditions Blood Coagulation Disorders
Last reviewed 2026-06-13 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.