NCT07706673

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,700

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Aug 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

August 3, 2026

Expected
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2031

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4.2 years

First QC Date

July 15, 2026

Last Update Submit

July 25, 2026

Conditions

Human Papillomavirus-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

  • First type-specific occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection

    Up to study completion

  • First any-type occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection

    Up to study completion

Study Arms (1)

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

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
Observational

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participates in ESCUDDO base study

You may qualify if:

  • \* 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

You may not qualify if:

  • \* Enrollment cannot occur beyond her 10 year study visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, 50101, Costa Rica

Location

Study Officials

  • Aimee Kreimer

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 16, 2026

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

January 15, 2031

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations

CO(1)