Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

NCT ID: NCT03309033

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

991 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2026-02-28

Brief Summary

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This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.

Detailed Description

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PRIMARY OBJECTIVES:

I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.

SECONDARY OBJECTIVES:

I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.

II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.

III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.

OUTLINE: This is an observational study.

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.

Conditions

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Human Papillomavirus Infection Human Papillomavirus-Related Malignant Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (questionnaire, biospecimen collection)

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

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Inclusion Criteria

* Participation in the CVT Long Term Follow-Up (LTFU) study

Exclusion Criteria

* A random subset of the three-dose women
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aimee R Kreimer

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, Costa Rica

Site Status

Countries

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Costa Rica

Other Identifiers

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NCI-2020-07430

Identifier Type: REGISTRY

Identifier Source: secondary_id

20G012-07

Identifier Type: -

Identifier Source: secondary_id

999917173

Identifier Type: -

Identifier Source: secondary_id

CEC-ICIC-E095-2017

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2020-07430

Identifier Type: -

Identifier Source: org_study_id

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