A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano [VPH]")

July 15, 2026 updated by: National Cancer Institute (NCI)

A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")

This study evaluates the long term protection provided by either one or two doses of the HPV vaccine for patients who were part of the ESCUDDO study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.

II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.

OUTLINE: This is an observational study.

Patients undergo vaginal and anal swab self sample collection, blood, urine sample collection, complete questionnaires, and have their medical records reviewed on study.

Study Type

Observational

Enrollment (Estimated)

9700

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)
        • Contact:
        • Principal Investigator:
          • Carolina Porras

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

Participates in ESCUDDO base study

Description

Inclusion Criteria:

  • * Participation in ESCUDDO base study

    • Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
    • A signed informed consent form for ESCUDDO LTFU.
    • Opportunity to complete three total study visits

Exclusion Criteria:

  • * Enrollment cannot occur beyond her 10 year study visit

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
Patients undergo vaginal and anal swab self sample collection, blood, urine sample collection, complete questionnaires, and have their medical records reviewed on study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First type-specific occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection
Time Frame: Up to study completion
Up to study completion
First any-type occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection
Time Frame: Up to study completion
Up to study completion

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)

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 (Estimated)

August 3, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

January 15, 2031

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NCI-2026-05053 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 26-C-NXXX (Other Identifier: National Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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