Evidence map›Paper›PMID 22634446›Full record

Trial reportHuman vaccines & immunotherapeutics2012

A randomized trial of immunotherapy for persistent genital warts.

David Jardine, Jieqiang Lu, James Pang, Cheryn Palmer, Quanmei Tu, John Chuah, Ian H Frazer

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Genital warts treatment: Beyond imiquimod.Human vaccines & immunotherapeutics · 2018
    Review
  5. Review
  6. Review
  7. Article
  8. 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

7 authors at 5 institutions in 6 countries.

David JardinePrincess Alexandra Sexual Health, Princess Alexandra Hospital, Brisbane, QLD, Australia.
Jieqiang Lu
James Pang
Cheryn Palmer
Quanmei Tu
John Chuah
Ian H Frazer
Brisbane School of Theology · AUWenzhou Medical University · CNDiamant (Germany) · DEPrincess Alexandra Hospital · AUSexual Health Clinic · FI

Funding

Wellcome Trust
6 · The paper itself

Abstract

aimTo determine whether immunotherapy with HPV6 L1 virus like particles (VLPs) without adjuvant (VLP immunotherapy) reduces recurrence of genital warts following destructive therapy. TRIAL

designA randomized placebo controlled blinded study of treatment of recurrent genital warts amenable to destructive therapy, conducted independently in Australia and China.

methodsPatients received conventional destructive therapy of all evident warts together with intramuscular administration of 1 µg, 5 µg or 25 µg of VLP immunotherapy, or of placebo immunotherapy (0.9% NaCl), as immunotherapy at week 0 and week 4. Primary outcome, assessed at week 8, was recurrence of visible warts.

resultsOf 33 protocol compliant Brisbane recipients of placebo immunotherapy, 11 were disease free at two months, and a further 9 demonstrated reduction of > 50% in total wart area. Wart area reduction following destructive treatment correlated with prior duration of disease. Among 102 protocol compliant Brisbane recipients of VLP immunotherapy, disease reduction was significantly greater than among the placebo immunotherapy (50% ± s.e.m. 7%) recipients for subjects receiving 5 µg or 25 µg of VLP immunotherapy/dose (71% ± s.e.m. 7%) but not for those receiving 1 µg VLP immunotherapy/dose (42% ± 7%). Of 52 protocol compliant placebo immunotherapy recipients in Wenzhou, 37 were disease free at two months, and a further 8 had > 50% disease reduction. Prior disease duration was much shorter in Wenzhou subject (8.1 ± 1.1 mo) than in Brisbane subjects (53.7 ± 5.5 mo). No significant reduction in mean wart area was observed for the 168 Wenzhou protocol compliant subjects who also received VLP immunotherapy.

conclusionsThis study confirms the findings in a previous open label trial that administration of VLP immunotherapy may assist in clearance of recurrent genital warts in patients for whom destructive therapy is unsuccessful and that unsuccessful destructive therapy is more common with increasing prior disease duration.

Indexed as

AdolescentAdultAustraliaCapsid ProteinsChinaChronic DiseaseCondylomata AcuminataDouble-Blind MethodFemaleHuman papillomavirus 16HumansImmunotherapyMaleOncogene Proteins, ViralPapillomavirus VaccinesPlacebosCapsid ProteinsL1 protein, Human papillomavirus type 16Oncogene Proteins, ViralPapillomavirus VaccinesPlacebosVaccines, Virosome

Identifiers

PMID22634446
PMCPMC3495719
OpenAlexW2030507185

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.