Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

December 24, 2022 updated by: National Cancer Institute (NCI)

Extended Follow-Up of Young Women in Costa Rica Who Received Vaccination Against Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women.

II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection.

III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations.

OUTLINE:

Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.

Study Type

Observational

Enrollment (Anticipated)

8670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
    • Guanacaste
      • Liberia, Guanacaste, Costa Rica, 50101
        • Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Young women in Costa Rica who received vaccination against human papillomavirus types 16 and 18 and unvaccinated controls.

Description

Inclusion Criteria:

  • Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
  • Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
  • A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
  • Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
  • UNVACCINATED CONTROL GROUP:
  • Born in or between July 1978 and November 1987
  • Residents of Guanacaste Province and a few areas of Puntarenas closest to Guanacaste at some point during 2005
  • Able to speak/understand Spanish
  • Apparently mentally competent
  • Written informed consent obtained prior to enrollment

Exclusion Criteria:

  • History of cervical cancer
  • History of hysterectomy
  • Any important medical condition or other criteria that the investigator considers that precludes enrollment
  • Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (long term follow-up)
Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Names:
  • Cytologic Sampling
Other: Long-term Follow-up
Undergo extended follow-up
Other Names:
  • long term follow-up (clinical study)
  • LTFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative rate of cervical intraepithelial neoplasia 3 (CIN3)
Time Frame: At 10 years
Both absolute rate differences and percent reduction in rates will be evaluated.
At 10 years
Level of immune response markers as prediction of long-term success of HPV vaccine
Time Frame: Up to 10 years
For efficiency, a nested case-control approach is envisioned to evaluate this question. We propose to compare women who become infected against a subset of those who do not (non-failures) with respect to immune response markers of interest.
Up to 10 years
Increase in the rate of cervical lesions associated with other carcinogenic HPV types that the vaccine does not protect against from prevention of HPV-16/18 associated cervical lesions through vaccination
Time Frame: Up to 10 years
The 10-year cumulative rate of incident CIN2+ associated with HPV types other than HPV-16/18 and closely related HPV types in the alpha-7/9 species for which evidence of vaccine cross-protection is demonstrated will be compared between vaccinated and unvaccinated women.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Aimee Kreimer, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2009

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 20, 2009

First Submitted That Met QC Criteria

March 20, 2009

First Posted (Estimate)

March 23, 2009

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2016-00231 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 999909106
  • 09-C-N106 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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