Evidence map›Paper›PMID 25796338›Full record

Trial reportVaccine2015

Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica.

Paula Gonzalez, Allan Hildesheim, Rolando Herrero, Hormuzd Katki, Sholom Wacholder, Carolina Porras, Mahboobeh Safaeian, Silvia Jimenez, Teresa M Darragh, Bernal Cortes and 16 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

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  10. Sample Size Estimations Based on Human Microbiome Temporal Stability Over 6 Months: A Shallow Shotgun Metagenome Sequencing Analysis.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
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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

26 authors at 10 institutions in 4 countries.

Paula GonzalezProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica; International Agency for Research on Cancer, Lyon, France. Electronic address: pgonzalez@proyectoguanacaste.org.
Allan HildesheimDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Rolando HerreroInternational Agency for Research on Cancer, Lyon, France.
Hormuzd KatkiDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Sholom WacholderDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Carolina PorrasProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Mahboobeh SafaeianDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Silvia JimenezInternational Agency for Research on Cancer, Lyon, France.
Teresa M DarraghUniversity of California, San Francisco (UCSF), San Francisco, CA, USA.
Bernal CortesProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Brian BefanoInformation Management Services (IMS), Calverton, MD, USA.
Mark SchiffmanDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Loreto CarvajalProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Joel PalefskyUniversity of California, San Francisco (UCSF), San Francisco, CA, USA.
John SchillerCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Rebeca OcampoProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
John SchusslerInformation Management Services (IMS), Calverton, MD, USA.
Douglas LowyCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Diego GuillenProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Mark H StolerDepartment of Pathology, University of Virginia, Charlottesville, VA, USA.
Wim QuintDDL Diagnostic Laboratory, Rijswijk, The Netherlands.
Jorge MoralesProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Carlos AvilaProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Ana Cecilia RodriguezProyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.
Aimée R KreimerDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Costa Rica HPV Vaccine Trial (CVT) Group
Guanacaste Conservation Area · CRCentre International de Recherche sur le Cancer · FRDivision of Cancer Epidemiology and GeneticsNational Cancer Institute · USCenter for Cancer Research · USInformation Management Services · USInstituto Costarricense de Investigación y Enseñanza en Nutrición y Salud · CRUniversity of California, San Francisco · USDDL Diagnostic Laboratory · NLUniversity of Virginia · US

Funding

Understanding Papillomavirus Virion Proteins and VaccinesZIABC009052 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHILLER, JOHN T. · 2009 to 2025
$38.4M
HPV and cancer at multiple anatomic sitesZIACP010209 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI KREIMER, AIMEE · 2010 to 2025
$7.9M
HPV Vaccine TrialsZIACP010177 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI HILDESHEIM, ALLAN · 2009 to 2009
$3.2M
Intramural NIH HHS ZIA CP010177NCI NIH HHS N01 CP011005World Health Organization 001
6 · The paper itself

Abstract

The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines.

Indexed as

Papillomavirus VaccinesAdultCosta RicaCross-Over StudiesEarly Detection of CancerFemaleFollow-Up StudiesHepatitis A VaccinesHuman papillomavirus 16Human papillomavirus 18HumansPapillomavirus InfectionsResearch DesignTime FactorsUterine Cervical DiseasesUterine Cervical DysplasiaHepatitis A VaccinesPapillomavirus VaccinesHuman papillomavirusLong term follow-upMethodsVaccines

Identifiers

PMID25796338
PMCPMC4390538
OpenAlexW2050436033

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.