Evidence map›Paper›PMID 21179010›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2011

Replication-competent lentivirus analysis of clinical grade vector products.

Kenneth Cornetta, Jing Yao, Aparna Jasti, Sue Koop, Makhaila Douglas, David Hsu, Larry A Couture, Troy Hawkins, Lisa Duffy

Abstract read
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed.

  1. Article
  2. Article
  3. FromImmune network · 2026
    Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Production of Therapeutic Enzymes by Lentivirus Transgenesis.Advances in experimental medicine and biology · 2019
    Review
  12. Detection of Replication Competent Lentivirus Using a qPCR Assay for VSV-G.Molecular therapy. Methods & clinical development · 2018
    Article
  13. Seek and You Will Not Find: Ending the Hunt for Replication-Competent Retroviruses during Human Gene Therapy.Molecular therapy : the journal of the American Society of Gene Therapy · 2018
    Article
  14. Absence of Replication-Competent Lentivirus in the Clinic: Analysis of Infused T Cell Products.Molecular therapy : the journal of the American Society of Gene Therapy · 2018
    Article
  15. Retroviral and Lentiviral Safety Analysis of Gene-Modified T Cell Products and Infused HIV and Oncology Patients.Molecular therapy : the journal of the American Society of Gene Therapy · 2018
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kenneth CornettaDepartment of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. kcornett@iupui.edu
Jing Yao
Aparna Jasti
Sue Koop
Makhaila Douglas
David Hsu
Larry A Couture
Troy Hawkins
Lisa Duffy

Funding

NGVL: SAFETY TESTS SERVICES TO NGVL CENTERS GENERATING CLINICAL GRADE MATERIALU42RR011148 · NCRR · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI CORNETTA, KENNETH · 1995 to 2007
$13.1M
BASIC SCIENCE STUDIES ON GENE THERAPY OF BLOOD DISEASEST32HL007910 · NHLBI · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI Roland W. Herzog, Reuben Kapur · 1999 to 2026
$7.6M
National Gene Vector Biorepository and Coordinating Center at Indiana UniversityP40HL116242 · NHLBI · INDIANA UNIVERSITY INDIANAPOLIS · PI CORNETTA, KENNETH · 2012 to 2017
$5.5M
National Gene Vector Biorespository and Coordinating Center at Indiana UniversityP40RR024928 · NCRR · INDIANA UNIVERSITY INDIANAPOLIS · PI CORNETTA, KENNETH · 2008 to 2011
$4.0M
NCRR NIH HHS P40 RR024928NCRR NIH HHS U42 RR011148NCRR NIH HHS U42RR11148NHLBI NIH HHS P40 HL116242NHLBI NIH HHS T32 HL007910
6 · The paper itself

Abstract

Lentiviral vectors are now in clinical trials for a variety of inherited and acquired disorders. A challenge for moving any viral vector into the clinic is the ability to screen the vector product for the presence of replication-competent virus. Assay development for replication-competent lentivirus (RCL) is particularly challenging because recombination of vector packaging plasmids and cellular DNA leading to RCL has not been reported with the current viral vector systems. Therefore, the genomic structure of a RCL remains theoretical. In this report, we describe a highly sensitive RCL assay suitable for screening vector product and have screened large-scale vector supernatant, cells used in vector production, and cells transduced with clinical grade vector. We discuss the limitations and challenges of the current assay, and suggest modifications that may improve the suitability of this assay for screening US Food and Drug Administration (US FDA)-licensed products.

Indexed as

Virus ReplicationCell LineEnzyme-Linked Immunosorbent AssayGenetic VectorsHEK293 CellsHIV Core Protein p24HumansLentivirusQuality ControlRecombination, GeneticReference StandardsReproducibility of ResultsSensitivity and SpecificityHIV Core Protein p24

Identifiers

PMID21179010
PMCPMC3048188

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.