Evidence map›Paper›PMID 19496531›Full record

Trial reportCancer immunity2009

Safety and immunogenicity of a human and mouse gp100 DNA vaccine in a phase I trial of patients with melanoma.

Jianda Yuan, Geoffrey Y Ku, Humilidad F Gallardo, Francesca Orlandi, Gregor Manukian, Teresa S Rasalan, Yinyan Xu, Hao Li, Shachi Vyas, Zhenyu Mu and 7 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunity, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
3.3field-weighted citation impact, top 7% of its field
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

42 citing papers in PubMed, 80 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Immunologic response to xenogeneic gp100 DNA in melanoma patients: comparison of particle-mediated epidermal delivery with intramuscular injection.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
    Trial
  4. Review
  5. Review
  6. Review
  7. Differential roles of human CD4Nature immunology · 2025
    Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Melanoma therapeutics: a literature review.Journal of biomedical research · 2022
    Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives.Journal of experimental & clinical cancer research : CR · 2019
    Review
  18. Melanoma treatment in review.ImmunoTargets and therapy · 2018
    Review
  19. Review
  20. Review
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

17 authors at 1 institution in 1 country.

Jianda YuanLudwig Center for Cancer Immunotherapy, Immunology Program, Sloan-Kettering Institute, New York, NY, USA.
Geoffrey Y Ku
Humilidad F Gallardo
Francesca Orlandi
Gregor Manukian
Teresa S Rasalan
Yinyan Xu
Hao Li
Shachi Vyas
Zhenyu Mu
Paul B Chapman
Susan E Krown
Katherine Panageas
Stephanie L Terzulli
Lloyd J Old
Alan N Houghton
Jedd D Wolchok
Kettering University · US

Funding

TREATMENT OF CANCER PATIENTS WITH THYMIC FACTORSP01CA033049 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI DIVGI, CHAITANYA R. · 1985 to 2009
$19.8M
Regulation by the Immune Response to Vaccines by BotanicalsP50AT002779 · NCCIH · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI LEUNG, PING CHUNG · 2005 to 2009
$7.2M
Summer research experiences for medical students supervised by faculty mentorsR25CA020449 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Charlotte Eielson Ariyan · 1985 to 2026
$6.2M
IMMUNIZATION AGAINST MELANOMA DIFFERENTIATION ANTIGENSR01CA056821 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI WOLCHOK, JEDD D. · 1992 to 2020
$5.7M
NCCIH NIH HHS P50AT002779NCI NIH HHS P01 CA033049NCI NIH HHS P01CA33049NCI NIH HHS R01 CA056821NCI NIH HHS R25 CA020449
6 · The paper itself

Abstract

A differentiation antigen commonly expressed on melanoma cells, gp100 is the target of infiltrating T cells. We conducted a phase I randomized cross-over trial of melanoma patients with either xenogeneic (mouse) or human gp100 plasmid DNA injected intramuscularly at three dosages (100, 500 or 1,500 microg) every three weeks for three doses. After the first three injections, patients were then immunized three times with gp100 from the other species. Peripheral blood samples were analyzed at various time points following 10-day culture with gp100 peptides using multi-parametric flow cytometry. A total of 19 patients were enrolled, with 18 assessable for immune function and survival. 14 (74%) were male, with a median age of 56 years (range, 20-82). All patients had no evidence of disease; 10 (53%) had stage III disease, 3 each (16%) had stage IIB and IV disease, 2 (11%) had choroidal and 1 (5%) had anal mucosal involvement. With a median follow-up of 30 months, median progression-free survival (PFS) is 44 months. Median survival is not reached. There was no grade 3/4 toxicity; the most common grade 1/2 toxicity was an injection site reaction in 12 patients (63%, all grade 1). Five patients developed CD8+ cells binding gp100(280-288) HLA-A2-restricted tetramer. One patient had an increase in CD8+ IFN-gamma+ cells. This xenogeneic immunization strategy was safe and associated with minimal toxicity. There was also evidence of immune response.

Indexed as

AdultAgedAged, 80 and overAnimalsAntigens, NeoplasmCancer VaccinesDisease-Free SurvivalFollow-Up Studiesgp100 Melanoma AntigenHLA-A2 AntigenHumansInjections, IntramuscularLymphocyte ActivationMaleMelanomaMembrane GlycoproteinsAntigens, NeoplasmCancer Vaccinesgp100(280-288) melanoma antigen peptidegp100 Melanoma AntigenHLA-A2 AntigenMembrane GlycoproteinsPeptide FragmentsPeptidesPMEL protein, humanPmel protein, mouseVaccines, DNA

Identifiers

PMID19496531
PMCPMC2888533
OpenAlexW2102415734

What OpenQuestion holds

Textmetadata
LicenceTDM
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.