Evidence map›Paper›PMID 22303476›Full record

ArticlePloS one2012

International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials.

Daniel A Ozaki, Hongmei Gao, Christopher A Todd, Kelli M Greene, David C Montefiori, Marcella Sarzotti-Kelsoe

Abstract read
In one paragraph

Article in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing 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

33 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Herbal formulations, Product Nkabinde andFrontiers in pharmacology · 2025
    Article
  7. Article
  8. HIV-1 prehairpin intermediate inhibitors show efficacy independent of neutralization tier.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  9. Article
  10. Article
  11. Broadly neutralizing monoclonal antibodies for HIV prevention.Journal of the International AIDS Society · 2021
    Article
  12. Article
  13. Article
  14. The high-affinity immunoglobulin receptor FcγRI potentiates HIV-1 neutralization via antibodies against the gp41 N-heptad repeat.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Neutralization Sensitivity of a Novel HIV-1 CRF01_AE Panel of Infectious Molecular Clones.Journal of acquired immune deficiency syndromes (1999) · 2018
    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

6 authors.

Daniel A OzakiDepartment of Surgery, Duke University Medical Center, Durham, North Carolina, United States of America.
Hongmei Gao
Christopher A Todd
Kelli M Greene
David C Montefiori
Marcella Sarzotti-Kelsoe

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.

Indexed as

InternationalityTechnology TransferAIDS VaccinesAntibodies, NeutralizingClinical Trials as TopicDEAE-DextranGuideline AdherenceHealth Plan ImplementationHeLa CellsHIV-1HIV AntibodiesHumansNeutralization TestsQuality Assurance, Health CareReproducibility of ResultsSensitivity and SpecificityAIDS VaccinesAntibodies, NeutralizingDEAE-DextranHIV Antibodies

Identifiers

PMID22303476
PMCPMC3267749

What OpenQuestion holds

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LicenceCC BY
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.