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
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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ACTIVE_NOT_RECRUITING
991 participants
OBSERVATIONAL
2018-07-02
2026-02-28
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
Undergo collection of blood samples
Questionnaire Administration
Complete questionnaire
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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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
Countries
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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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