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

May 12, 2026 updated by: National Cancer Institute (NCI)

Long-Term Immunologic Follow-Up of Women Who Received One, Two, and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT): Generating Durability Data: The ESCUDDO-CVT Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

946

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 Province
      • Liberia, Guanacaste Province, 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

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • A random subset of the three-dose women

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Other: Questionnaire Administration
Complete questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seropositivity
Time Frame: Up to 20 years after initial vaccination
Negative/positive status will be assessed using the standard predefined cutoffs established at the testing laboratory.
Up to 20 years after initial vaccination
Change in antibody levels
Time Frame: Between years 11 and 20 after initial vaccination
Will report the geometric mean titer levels and their 95% confidence intervals at years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20 for the 1-dose, 2-dose and 3-dose groups and for both human papillomavirus (HPV)-16 and HPV-18 antibodies. Will estimate these quantities using a weighted linear mixed models with log-titer level as the dependent variable and year as the independent variable, adjusting for laboratory batch and including a random-effects for participant and, when needed, participant: study year. For the three-dose analysis, will also include a covariate for study group. Moreover, will model the 19-year trend (e.g. excluding peak titers at year 1) by including time as a single continuous variable (i.e. linear effect) and then model time flexibly using a natural spline to assess a potentially non-linear relationship.
Between years 11 and 20 after initial vaccination
Proportion of individuals who serorevert
Time Frame: Between years 11 and 20 after initial vaccination
For each dose regimen and for HPV 16, HPV 18, and a composite endpoint of either HPV type, will estimate the proportion of individuals who serorevert (i.e., become antibody negative by the assay cutoff) in years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20. Will also report 95% confidence intervals for these estimates. Again, will follow the approach described in our previous work. Note, will consider both standard and updated cutoffs and will use batch-adjusted levels. Can obtain the relative risk for seroreversion and its 95% confidence interval using score tests. Will then use generalized linear mixed models with seroreversion as the outcome and all other parameters similar to above to assess trends over time.
Between years 11 and 20 after initial vaccination

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 R Kreimer, National Cancer Institute (NCI)

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)

July 2, 2018

Primary Completion (Actual)

March 5, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-07430 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 999917173
  • 20G012-07
  • CEC-ICIC-E095-2017 (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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