Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07706673

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

12 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, 50101, Costa Rica

Location contact

Carolina Porras

CONTACT

[email protected]

506-2668-1128

Carolina Porras

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

  • Merck Sharp and Dohme LLC

Registry information

Official study title

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)")

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 16, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.