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<p>Adeno-associated virus (AAV) vectors are essential tools for gene therapy (GT), yet preexisting immunity can hinder their efficacy. This study examines the seroprevalence of total binding IgG against AAV serotypes 2, 5, 6, 8, and 9, and neutralizing antibodies (NAb) against AAV 6, 8, and 9 serotypes in a healthy adult Spanish population. Using enzyme-linked immunosorbent assays (ELISA) for IgG and luciferase-based assays for NAb, we found that IgG seroprevalence was highest for AAV6 (84.4%), followed by AAV2 (74.4%) and AAV8 (60.0%), with the lowest prevalence observed for AAV9 (51.2%) and AAV5 (40.4%). For NAb, AAV6 showed the highest prevalence (62.8%), followed by AAV8 (60.4%) and AAV9 (52.4%). Co-prevalence analysis revealed high rates among all IgG-AAV serotypes tested (ranging from 46.4% to 97.0%) and significant co-occurrence of NAb against AAV6, AAV8, and AAV9 (83.0% to 91.0%). High NAb levels correlated with high IgG levels in all samples. The variability in seroprevalence across populations highlights the importance of personalized and validated testing to optimize treatment outcomes and ensure the safety of AAV-based gene therapies.</p>

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Seroprevalence of anti-AAV antibodies in a healthy adult Spanish population: findings from the SAAVIA study

  • 期刊论文

  • 发表日期：

    2026年3月12日

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  • Rafael Parra,
  • Assumpció Bosch,
  • Angela Sánchez,
  • Cristina Caparros,
  • Hae Kyung Kim,
  • Nadia Lwoff

摘要

Adeno-associated virus (AAV) vectors are essential tools for gene therapy (GT), yet preexisting immunity can hinder their efficacy. This study examines the seroprevalence of total binding IgG against AAV serotypes 2, 5, 6, 8, and 9, and neutralizing antibodies (NAb) against AAV 6, 8, and 9 serotypes in a healthy adult Spanish population. Using enzyme-linked immunosorbent assays (ELISA) for IgG and luciferase-based assays for NAb, we found that IgG seroprevalence was highest for AAV6 (84.4%), followed by AAV2 (74.4%) and AAV8 (60.0%), with the lowest prevalence observed for AAV9 (51.2%) and AAV5 (40.4%). For NAb, AAV6 showed the highest prevalence (62.8%), followed by AAV8 (60.4%) and AAV9 (52.4%). Co-prevalence analysis revealed high rates among all IgG-AAV serotypes tested (ranging from 46.4% to 97.0%) and significant co-occurrence of NAb against AAV6, AAV8, and AAV9 (83.0% to 91.0%). High NAb levels correlated with high IgG levels in all samples. The variability in seroprevalence across populations highlights the importance of personalized and validated testing to optimize treatment outcomes and ensure the safety of AAV-based gene therapies.