Evidence map›Paper›PMID 18640170›Full record

Trial reportVaccine2008

Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica.

Rolando Herrero, Allan Hildesheim, Ana C Rodríguez, Sholom Wacholder, Concepción Bratti, Diane Solomon, Paula González, Carolina Porras, Silvia Jiménez, Diego Guillen and 13 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 4% 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

106 citing papers in PubMed, 1 synthesis or guideline pooled it, 164 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

46 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

23 authors at 6 institutions in 2 countries.

Rolando HerreroProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Torre La Sabana, 300 Oeste del ICE, Piso 7, Sabana Norte, San José, Costa Rica. rherrero@amnet.co.cr
Allan Hildesheim
Ana C Rodríguez
Sholom Wacholder
Concepción Bratti
Diane Solomon
Paula González
Carolina Porras
Silvia Jiménez
Diego Guillen
Jorge Morales
Mario Alfaro
Jean Cyr
Kerrygrace Morrisey
Yenory Estrada
Bernal Cortés
Lidia Ana Morera
Enrique Freer
John Schussler
John Schiller
Douglas Lowy
Mark Schiffman
Costa Rica Vaccine Trial (CVT) Group
Instituto Costarricense de Investigación y Enseñanza en Nutrición y Salud · CRNational Cancer Institute · USCenter for Cancer Research · USDivision of Cancer Epidemiology and GeneticsUniversidad de Costa Rica · CRWestat (United States) · US

Funding

Papillomavirus Virion Proteins and VaccinesZIABC010579 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI LOWY, DOUGLAS R. · 2009 to 2025
$15.4M
Human papillomavirus vaccine trialsZ01CP010177 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI HILDESHEIM, ALLAN · 2001 to 2008
$500k
Intramural NIH HHS Z01 CP010177NCI NIH HHS N01 CP011005
6 · The paper itself

Abstract

We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.

Indexed as

AdolescentAdultCervix UteriChlamydia InfectionsChlamydia trachomatisCosta RicaDouble-Blind MethodFemaleHuman papillomavirus 16Human papillomavirus 18HumansImmunization, SecondaryLongitudinal StudiesPapillomavirus InfectionsPapillomavirus VaccinesPrevalencePapillomavirus Vaccines

Identifiers

PMID18640170
PMCPMC2652516
OpenAlexW2062597040

What OpenQuestion holds

Textmetadata
LicenceTDM
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.