New Update: NIH Guidelines for working with AAV and rAAV vectors

NEW UPDATE: NIH Guidelines

The “Guidelines for working with replication-incompetent Adeno-Associated (AAV), recombinant AdenoAssociated (rAAV), Lentivirus and Adeno viral vectors in lab and animal research” have been updated to reflect current NIH/OBA guidance.

What was the change in the NIH Guide?

Appendix B-1 assessed AAV and rAAV as Risk Group 1 (RG1) agents. RG1 agents are not associated with disease in healthy adult humans.

What is the change in the Emory University Guidelines for working with AAV and rAAV vectors?

The use of AAV and rAAV vectors in animals has been downgraded to ABSL1 if the following conditions are met:

• Transgene does not express an oncogenic protein or toxin.
• AAV/rAAV is generated without using adenovirus or any other helper virus of human origin.
• AAV/rAAV is propagated in insect cell lines or is purified sufficiently before use. The method and assessment of purification needs to be documented.

What has NOT changed?

BSL2/ABSL2 must be used when working with AAV and rAAV when:

1. Transgenes express an oncogenic protein or toxin.
2. Helper virus of human origin is used to generate AAV/rAAV.
3. AAV/rAAV is propagated in human cell lines without further purification before use.