Evidence map›Paper›PMID 21908768›Full record

Trial reportJournal of the National Cancer Institute2011

Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine.

Aimée R Kreimer, Ana Cecilia Rodriguez, Allan Hildesheim, Rolando Herrero, Carolina Porras, Mark Schiffman, Paula González, Diane Solomon, Silvia Jiménez, John T Schiller and 6 more

2 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 151 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 10 pooled it
–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.

NCT00128661 phase3completednot on this map

A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.

TypeinterventionalSponsorGlaxoSmithKlineRan2004 to 2010Enrolled7,466ConditionsCervical Cancer, Precancerous ConditionArmshuman papillomavirus 16/18 L1 virus-like particle/AS04 vaccine, hepatitis A inactivated virus vaccine
NCT02276521 completednot on this mapstarted 2015, after this paper: background citation

Evaluation of Long-term Immunological Responses Following Reduced Dose Quadrivalent Human Papillomavirus (HPV) Vaccine Schedules: A Phase II/III Clinical Trial

TypeobservationalSponsorMurdoch Childrens Research InstituteRan2015 to 2015Enrolled200ConditionsCervical Cancer, Anogenital WartsArmsCervarix®
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Sexually transmitted diseases treatment guidelines, 2015.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2015
    Guideline
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Aimée R KreimerInfections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 6120 Executive Blvd, EPS/7084, Rockville, MD 20852, USA. kreimera@mail.nih.gov
Ana Cecilia Rodriguez
Allan Hildesheim
Rolando Herrero
Carolina Porras
Mark Schiffman
Paula González
Diane Solomon
Silvia Jiménez
John T Schiller
Douglas R Lowy
Wim Quint
Mark E Sherman
John Schussler
Sholom Wacholder
CVT Vaccine Group

Funding

HPV and cancer at multiple anatomic sitesZIACP010209 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI KREIMER, AIMEE · 2010 to 2025
$7.9M
NCI NIH HHS N01 CP011005
6 · The paper itself

Abstract

backgroundThree-dose regimens for human papillomavirus (HPV) vaccines are expensive and difficult to complete, especially in settings where the need for cervical cancer prevention is greatest.

methodsWe evaluated the vaccine efficacy of fewer than three doses of the HPV16/18 vaccine Cervarix in our Costa Rica Vaccine Trial. Women were randomly assigned to receive three doses of the HPV16/18 vaccine or to a control vaccine and were followed for incident HPV16 or HPV18 infection that persisted in visits that were 10 or more months apart (median follow-up 4.2 years). After excluding women who had no follow-up or who were HPV16 and HPV18 DNA positive at enrollment, 5967 women received three vaccine doses (2957 HPV vaccine vs 3010 control vaccine), 802 received two doses (422 HPV vs. 380 control), and 384 received one dose (196 HPV vs. 188 control). Reasons for receiving fewer doses and other pre- and post-randomization characteristics were balanced within each dosage group between women receiving the HPV and control vaccines.

resultsIncident HPV16 or HPV18 infections that persisted for 1 year were unrelated to dosage of the control vaccine. Vaccine efficacy was 80.9% for three doses of the HPV vaccine (95% confidence interval [CI] = 71.1% to 87.7%; 25 and 133 events in the HPV and control arms, respectively), 84.1% for two doses (95% CI = 50.2% to 96.3%; 3 and 17 events), and 100% for one dose (95% CI = 66.5% to 100%; 0 and 10 events).

conclusionFour years after vaccination of women who appeared to be uninfected, this nonrandomized analysis suggests that two doses of the HPV16/18 vaccine, and maybe even one dose, are as protective as three doses.

Indexed as

AdolescentAdultAlphapapillomavirusAntibodies, ViralCosta RicaDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansPapillomavirus InfectionsPapillomavirus VaccinesResearch DesignTreatment OutcomeTumor Virus InfectionsUterine Cervical NeoplasmsYoung AdultAntibodies, Viralhuman papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines

Identifiers

PMID21908768
PMCPMC3186781

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.