Evidence map›Paper›PMID 20234368›Full record

Trial reportBritish journal of cancer2010

Phase II trial of imiquimod and HPV therapeutic vaccination in patients with vulval intraepithelial neoplasia.

S Daayana, E Elkord, U Winters, M Pawlita, R Roden, P L Stern, H C Kitchener

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 3 pooled it
12.3field-weighted citation impact, top 1% 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

111 citing papers in PubMed, 3 syntheses or guidelines pooled it, 247 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
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  11. Article
  12. Review
  13. Targeting innate immunity to overcome immune evasion in HPV-associated cancers.Frontiers in cellular and infection microbiology · 2026
    Review
  14. Article
  15. Article
  16. Review
  17. Review
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  19. Article
  20. Review

51 more citing papers are in PubMed but not listed here.

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

7 authors at 4 institutions in 3 countries.

S DaayanaAcademic Unit of Obstetrics and Gynaecology, University of Manchester, St Mary's Hospital, Whitworth Park, Manchester M13 0JH, UK.
E Elkord
U Winters
M Pawlita
R Roden
P L Stern
H C Kitchener
Cancer Research UK Manchester Institute · GBUniversity of Manchester · GBHeidelberg University · DEJohns Hopkins University · US

Funding

Treatment of HIV- and HIV+ Patients with HPV16+ CIN2/3 Using pNGLV4a-hCRTE6E7L2 DNA vaccine administered intramuscularly via electroporationP50CA098252 · NCI · JOHNS HOPKINS UNIVERSITY · PI Richard Bruce Roden · 2003 to 2026
$53.5M
Mechanisms of Papillomavirus NeutralizationR01CA118790 · NCI · JOHNS HOPKINS UNIVERSITY · PI RODEN, RICHARD BRUCE · 2007 to 2018
$2.9M
Cancer Research UKNCI NIH HHS P50 CA098252NCI NIH HHS R01 CA118790
6 · The paper itself

Abstract

backgroundVulval intraepithelial neoplasia (VIN) is a premalignant condition, which is frequently associated with type HPV16 infection, and multifocal disease has high rates of surgical treatment failure.

methodsWe report a phase II clinical trial of the topical immunomodulator, imiquimod, for 8 weeks, followed by 3 doses (weeks 10, 14 and 18) of therapeutic human papillomavirus (HPV) vaccination (TA-CIN, fusion protein HPV16 E6E7L2) in 19 women with VIN grades 2 and 3. Histology and HPV testing of biopsies were performed at weeks 0, 10, 20 and 52. Intralesional infiltration of T-cell subsets and lymphocyte proliferation for HPV systemic immune responses were also assessed.

resultsLesion response (complete regression of VIN on histology) was observed in 32% (6 out of 19) of women at week 10, increasing to 58% (11 out of 19) at week 20 and 63% (12 out of 19) at week 52. At this time, 36% (5 out of 14) of lesions showed HPV16 clearance and 79% (15 out of 19) of women were symptom free. At week 20, after treatment with imiquimod and vaccination, there was significantly increased local infiltration of CD8 and CD4 T cells in lesion responders; in contrast, non-responders (persistent VIN by histology) showed an increased density of T regulatory cells. After vaccination, only lesion responders had significantly increased lympho-proliferation to the HPV vaccine antigens.

conclusionThe therapeutic effect of treatment depends on the differential immune response of responders and non-responders with affect locally and systemically.

Indexed as

AdolescentAdultAgedAminoquinolinesAntigens, ViralAntineoplastic Combined Chemotherapy ProtocolsCancer VaccinesCarcinoma in SituDrug ToleranceFemaleHuman papillomavirus 16HumansImiquimodMiddle AgedPapillomavirus VaccinesVulvar NeoplasmsAminoquinolinesAntigens, ViralCancer VaccinesImiquimodPapillomavirus Vaccines

Identifiers

PMID20234368
PMCPMC2853099
OpenAlexW2072141671

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.