A Scientific Evaluation of One or Two Doses of a Vaccine... | NCT07706673

Studies
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]")

NCT07706673

Sponsor

National Cancer Institute (NCI)

Status

Not yet recruiting

Last Update Posted

Jul 16, 2026Actual

Enrollment

9,700Estimated

Phase

Not provided

Conditions

Human Papillomavirus-Related Malignant Neoplasm

Interventions

Non-Interventional Study

Countries

Costa Rica

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2026-05053	Registry Identifier	CTRP (Clinical Trial Reporting Program)
26-C-NXXX	Other Identifier	National Cancer Institute

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2026Estimated

Primary Completion Date

Oct 1, 2030Estimated

Completion Date

Jan 15, 2031Estimated

First Submitted Date

Jul 15, 2026

First Submission Date that Met QC Criteria

Jul 15, 2026

First Posted Date

Jul 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2026

Last Update Posted Date

Jul 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participates in ESCUDDO base study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aimee Kreimer	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Agencia Costarricense de Investigaciones Biomédicas (ACIB)		Liberia	Guanacaste Province	50101	Costa Rica

Derived Section

Miscellaneous Info Module

Version Holder

Jul 17, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.