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Related Concept Videos

Antibody Actions01:26

Antibody Actions

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Antibodies, or immunoglobulins, are critical players in the immune system's arsenal against invading pathogens. Produced by B cells and plasma cells, their primary role is to detect and bind to specific antigens, molecules found on the surface of pathogens like bacteria or viruses. Beyond antigen recognition, antibodies perform several vital functions that contribute to immune defense.
Neutralization
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Immune Response Against Viral Pathogens01:29

Immune Response Against Viral Pathogens

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The immune system's response to viral infections is a complex and coordinated process involving natural killer (NK) cells, T cell-mediated responses, and antibody-mediated responses.
NK Cells
NK cells are a crucial part of our innate immune system, acting as the first line of defense against viral infections. These cells can recognize and kill infected cells without prior exposure to the virus, effectively slowing down the spread of infection. Additionally, NK cells produce proinflammatory...
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Affinity and Avidity01:41

Affinity and Avidity

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Overview
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Updated: Aug 2, 2025

Combined Genetic and Chemical Capsid Modifications of Adenovirus-Based Gene Transfer Vectors for Shielding and Targeting
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Complement Activation by Adeno-Associated Virus-Neutralizing Antibody Complexes.

Cara West1, Joel D Federspiel2, Kara Rogers3

  • 1Pfizer, Inc., Rare Disease Research Unit, Cambridge, Massachusetts, USA.

Human Gene Therapy
|April 21, 2023
PubMed
Summary

Preexisting antibodies against adeno-associated virus (AAV) vectors can trigger complement activation, a key safety concern for gene therapy. This risk, linked to IgG1 levels, can be managed with immunosuppression in seropositive patients.

Keywords:
AAVcomplement activationneutralizing antibodies

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Area of Science:

  • Immunology
  • Gene Therapy
  • Virology

Background:

  • Adeno-associated virus (AAV) vectors are promising for treating monogenetic disorders.
  • Prevalent anti-AAV antibodies in the population pose challenges to gene therapy safety and efficacy.
  • Understanding immune responses to AAV is critical for successful therapeutic development.

Purpose of the Study:

  • To investigate the risk of complement activation induced by AAV9 capsids in human sera with pre-existing antibodies.
  • To identify the correlation between antibody levels and complement activation.
  • To explore methods for mitigating AAV-mediated complement activation.

Main Methods:

  • Exposure of human donor sera to AAV9 capsids.
  • Measurement of complement activation.
  • Mass spectrometry analysis of immunoglobulin and complement factor binding.
  • IgG depletion and enzymatic degradation of IgG in sera.

Main Results:

  • Sera with pre-existing neutralizing anti-AAV antibodies activated complement upon AAV9 capsid exposure.
  • Complement activation correlated with higher levels of anti-AAV IgG1 antibodies.
  • Mass spectrometry confirmed increased binding of immunoglobulins and complement factors.
  • IgG depletion or degradation abrogated complement activation.

Conclusions:

  • Preexisting neutralizing antibodies play a significant role in AAV-mediated complement activation.
  • This immune response presents a risk for gene therapy in seropositive individuals.
  • Immunosuppression strategies can mitigate complement activation risks in seropositive patients receiving AAV vectors.