ESCUDDO Long Term Follow Up

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 phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.

PRIMARY OBJECTIVES:

I. To estimate the Incidence Rate Difference (IRD) and Relative Risk (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 interventional study. Participants are assigned to 1 of 3 arms.

Arm I (ONE DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.

Arm II (TWO DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.

Arm III (UNVACCINATED): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study. These women will be offered HPV vaccination (Gardasil9).

Trial participants with documented persistent type-specific HPV infections will be triaged to colposcopy and may undergo biopsy collection and treatment.

Inclusion Criteria:

• TRIAL PARTICIPANTS: Participation in ESCUDDO base study
• TRIAL PARTICIPANTS: Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
• TRIAL PARTICIPANTS: A signed informed consent form for ESCUDDO LTFU
• TRIAL PARTICIPANTS: Opportunity to complete three total study visits
• LTFU SURVEY GROUP: We will match the current ages of ESCUDDO LTFU trial participants when they attend their 9.5-year study visit (21 to 26 years of age)

Exclusion Criteria:

• TRIAL PARTICIPANTS: Enrollment cannot occur beyond her 10 year study visit
• LTFU SURVEY GROUP: They report they are pregnant
• LTFU SURVEY GROUP: They report being vaccinated against HPV
• LTFU SURVEY GROUP: The qualified healthcare personnel determining eligibility, in agreement with principal investigator, considers a reason that precludes participation; or
• LTFU SURVEY GROUP: They do not have an identification document