Certification assays for HIV-1-based vectors: frequent passage of gag sequences without evidence of replication-competent viruses

Mol Ther. 2003 Nov;8(5):830-9. doi: 10.1016/j.ymthe.2003.08.003.

Abstract

A principal concern regarding the safety of HIV-1-based vectors is replication-competent lentivirus (RCL). We have developed two PCR assays for detecting RCL; the first detects recombination between gag regions in the transfer vector and the packaging construct (sensitivity of detection approximately 10-100 copies of target sequence). The second assay uses real-time PCR to detect vesicular stomatitis virus glycoprotein (VSVG) envelope DNA (sensitivity approximately 5-50 VSVG sequences). In an attempt to amplify any RCL, test vectors were used to transduce C8166 and 293 cells, which were then screened weekly for 3 weeks. Psi-gag recombinants were routinely detected (20 of 21 analyses) in four transductions using the RRL-CMV-GFP vector. In contrast, VSVG sequences were detected only once in 21 analyses. Interestingly, p24 levels (as measured by ELISA) were occasionally detectable after 3 weeks of culture. To determine if a true RCL was present, 21-day cell-free medium was used to transduce naïve cells. No evidence of psi-gag or VSVG transfer was detected, indicating that the recombination events were insufficient to reconstitute a true RCL. These findings have important implications for the design and safety of HIV-1-based vectors intended for clinical applications.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Base Sequence
  • Cell Line
  • Cell Line, Tumor
  • Enzyme-Linked Immunosorbent Assay
  • Gene Products, gag / genetics*
  • Gene Transfer Techniques*
  • Genetic Vectors*
  • Green Fluorescent Proteins
  • HIV-1 / genetics*
  • HeLa Cells
  • Humans
  • Luminescent Proteins / metabolism
  • Membrane Glycoproteins / genetics
  • Models, Genetic
  • Molecular Sequence Data
  • Polymerase Chain Reaction
  • Quality Control
  • Reverse Transcriptase Polymerase Chain Reaction
  • Time Factors
  • Transduction, Genetic
  • Viral Envelope Proteins / genetics

Substances

  • G protein, vesicular stomatitis virus
  • Gene Products, gag
  • Luminescent Proteins
  • Membrane Glycoproteins
  • Viral Envelope Proteins
  • Green Fluorescent Proteins