Evidence map›Paper›PMID 26467666›Full record

Trial reportJournal of the National Cancer Institute2016

Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection.

Daniel C Beachler, Aimée R Kreimer, Mark Schiffman, Rolando Herrero, Sholom Wacholder, Ana Cecilia Rodriguez, Douglas R Lowy, Carolina Porras, John T Schiller, Wim Quint and 7 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 8 pooled it
8.1field-weighted citation impact, top 2% 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

57 citing papers in PubMed, 8 syntheses or guidelines pooled it, 124 citations in OpenAlex.

  1. Pooled it
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  9. Trial
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  11. Article
  12. Review
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  14. U.S. Vietnamese Parents' Perceptions of Different Approaches for Confirming Adolescent HPV Vaccination Records in Research Studies.Health expectations : an international journal of public participation in health care and health policy · 2025
    Article
  15. Article
  16. Article
  17. Review
  18. Human papillomavirus (HPV) and Epstein-Barr virus (EBV) in Penile Cancer in Thailand.Asian Pacific journal of cancer prevention : APJCP · 2024
    Article
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  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 4 countries.

Daniel C BeachlerDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS). daniel.beachler@nih.gov.
Aimée R KreimerDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Mark SchiffmanDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Rolando HerreroDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Sholom WacholderDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Ana Cecilia RodriguezDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Douglas R LowyDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Carolina PorrasDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
John T SchillerDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Wim QuintDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Silvia JimenezDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Mahboobeh SafaeianDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Linda StruijkDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
John SchusslerDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Allan HildesheimDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Paula GonzalezDivision of Cancer Epidemiology, and Genetics (DCB, ARK, MS, SW, MS, AH) and Center for Cancer Research (DRL, JTS), National Cancer Institute, NIH, Bethesda, MD; Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica (RH, ACR, CP, SJ, PG); Early Detection and Prevention Section, International Agency for Research on Cancer, Lyon, France (RH); DDL Diagnostic Laboratory, Voorburg, the Netherlands (WQ, LS); Information Management Systems, Rockville, MD (JS).
Costa Rica HPV Vaccine Trial (CVT) Group
DDL Diagnostic Laboratory · NLInformation Management Services · USCentre International de Recherche sur le Cancer · FRCenter for Cancer Research · USInstituto Costarricense de Investigación y Enseñanza en Nutrición y Salud · CRNational Cancer Institute · US

Funding

Understanding Papillomavirus Virion Proteins and VaccinesZIABC009052 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHILLER, JOHN T. · 2009 to 2025
$38.4M
Papillomavirus Virion Proteins and VaccinesZIABC010579 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI LOWY, DOUGLAS R. · 2009 to 2025
$15.4M
NCI NIH HHS N01 CP011005NCI NIH HHS N01-CP-11005World Health Organization 001
6 · The paper itself

Abstract

backgroundPrevious Costa Rica Vaccine Trial (CVT) reports separately demonstrated vaccine efficacy against HPV16 and HPV18 (HPV16/18) infections at the cervical, anal, and oral regions; however, the combined overall multisite efficacy (protection at all three sites) and vaccine efficacy among women infected with HPV16 or HPV18 prior to vaccination are less known.

methodsWomen age 18 to 25 years from the CVT were randomly assigned to the HPV16/18 vaccine (Cervarix) or a hepatitis A vaccine. Cervical, oral, and anal specimens were collected at the four-year follow-up visit from 4186 women. Multisite and single-site vaccine efficacies (VEs) and 95% confidence intervals (CIs) were computed for one-time detection of point prevalent HPV16/18 in the cervical, anal, and oral regions four years after vaccination. All statistical tests were two-sided.

resultsThe multisite woman-level vaccine efficacy was highest among "naïve" women (HPV16/18 seronegative and cervical HPV high-risk DNA negative at vaccination) (vaccine efficacy = 83.5%, 95% CI = 72.1% to 90.8%). Multisite woman-level vaccine efficacy was also demonstrated among women with evidence of a pre-enrollment HPV16 or HPV18 infection (seropositive for HPV16 and/or HPV18 but cervical HPV16/18 DNA negative at vaccination) (vaccine efficacy = 57.8%, 95% CI = 34.4% to 73.4%), but not in those with cervical HPV16 and/or HPV18 DNA at vaccination (anal/oral HPV16/18 VE = 25.3%, 95% CI = -40.4% to 61.1%). Concordant HPV16/18 infections at two or three sites were also less common in HPV16/18-infected women in the HPV vaccine vs control arm (7.4% vs 30.4%, P < .001).

conclusionsThis study found high multisite vaccine efficacy among "naïve" women and also suggests the vaccine may provide protection against HPV16/18 infections at one or more anatomic sites among some women infected with these types prior to HPV16/18 vaccination.

Indexed as

AdultAnal CanalAnus NeoplasmsCervix UteriCosta RicaFemaleHuman papillomavirus 16Human papillomavirus 18HumansMouth MucosaMouth NeoplasmsPapillomavirus InfectionsPapillomavirus VaccinesTreatment OutcomeUterine Cervical NeoplasmsVaccinationhuman papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccines

Identifiers

PMID26467666
PMCPMC4862406
OpenAlexW2269417520

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Registered trials

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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.