Evidence map›Paper›PMID 24958910›Full record

Trial reportThe Journal of infectious diseases2014

Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine: a nested analysis within the Costa Rica Vaccine Trial.

Krystle A Lang Kuhs, Paula Gonzalez, Ana Cecilia Rodriguez, Leen-Jan van Doorn, Mark Schiffman, Linda Struijk, Sabrina Chen, Wim Quint, Douglas R Lowy, Carolina Porras and 9 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00128661 (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), which is not on this map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 12% 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.

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
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Prophylactic and Therapeutic HPV Vaccines: Current Scenario and Perspectives.Frontiers in cellular and infection microbiology · 2022
    Review
  5. Article
  6. Review
  7. 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

19 authors at 5 institutions in 4 countries.

Krystle A Lang KuhsNational Cancer Institute, NIH, Bethesda, Maryland.
Paula GonzalezProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica Prevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.
Ana Cecilia RodriguezProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica.
Leen-Jan van DoornDDL Diagnostic Laboratory, Rijswijk, The Netherlands.
Mark SchiffmanNational Cancer Institute, NIH, Bethesda, Maryland.
Linda StruijkDDL Diagnostic Laboratory, Rijswijk, The Netherlands.
Sabrina ChenInformation Management Services, Calverton, Maryland.
Wim QuintDDL Diagnostic Laboratory, Rijswijk, The Netherlands.
Douglas R LowyNational Cancer Institute, NIH, Bethesda, Maryland.
Carolina PorrasProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica.
Corey DelVecchioInformation Management Services, Calverton, Maryland.
Silvia JimenezProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica.
Mahboobeh SafaeianNational Cancer Institute, NIH, Bethesda, Maryland.
John T SchillerNational Cancer Institute, NIH, Bethesda, Maryland.
Sholom WacholderNational Cancer Institute, NIH, Bethesda, Maryland.
Rolando HerreroPrevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.
Allan HildesheimNational Cancer Institute, NIH, Bethesda, Maryland.
Aimée R Kreimer
Costa Rica Vaccine Trial Group
National Cancer Institute · USInstituto Costarricense de Investigación y Enseñanza en Nutrición y Salud · CRDDL Diagnostic Laboratory · NLInformation Management Services · USCentre International de Recherche sur le Cancer · FR

Funding

Understanding Papillomavirus Virion Proteins and VaccinesZIABC009052 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHILLER, JOHN T. · 2009 to 2025
$38.4M
NCI NIH HHS N01 CP011005World Health Organization 001
6 · The paper itself

Abstract

backgroundVaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse.

methodsWomen (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536).

resultsVulvar HPV16/18 VE (54.1%; 95% confidence interval [CI], 4.9%-79.1%) was comparable to cervix (45.8%; 95% CI, 6.4%-69.4%). Vulvar and cervical HPV16 prevalence within the control arm was 3.0% and 4.7%, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95% CI, .3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95% CI, 1.5-3.5] single vs married/living-as-married); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1).

conclusionsIn this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. CLINICAL TRIALS REGISTRATION: NCT00128661.

Indexed as

AdolescentAdultCervix UteriCosta RicaDNA, ViralFemaleHuman papillomavirus 16Human papillomavirus 18HumansPapillomavirus InfectionsPapillomavirus VaccinesPrevalenceRisk FactorsVulvaVulvar DiseasesYoung AdultDNA, ViralPapillomavirus VaccinesCosta RicaHPVHPV vaccinevulvar human papillomavirus vaccine

Identifiers

PMID24958910
PMCPMC4271025
OpenAlexW2136803907

What OpenQuestion holds

Textmetadata
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.