ESCUDDO Long Term Follow Up

Phase 4Enrolling By InvitationNCT07706673

National Cancer Institute (NCI)13,700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

13,700

Conditions

Human Papillomavirus Infection Human Papillomavirus-Related Malignant Neoplasm

Interventions

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedBIOLOGICAL

Given IM in ESCUDDO (NCT03180034)

Recombinant Human Papillomavirus Nonavalent VaccineBIOLOGICAL

Given intramuscularly (IM) in ESCUDDO (NCT03180034)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, Costa Rica

Outcomes

Primary Outcomes

Comparison of incident persistent human papillomavirus (HPV) infection related to vaccine types observed during long-term follow-up study (LFTU) and the combined ESCUDDO base and LTFU studies; in recipients of single dose and 2 doses of the 9vHPV vaccine

Estimate the incidence rate difference and relative risk of first type-specific 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose and 2 doses of Gardasil9. Study measures include self-collected cervicovaginal swabs collected every 6 months, HPV genotyping using the TypeSeq2 assay, identification of type-specific persistent infection based on two positive samples collected ≥3 months apart, and calculation of incidence rates in the Per-Protocol Efficacy (PPE) population.

Time frame: 7 to 10 years after first HPV vaccination

Comparison of cumulative persistent HPV infection (Base Study + LTFU)

Estimate the incidence rate difference and relative risk of first any-type 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose versus 2 doses of Gardasil9 over the combined study period. Study measures include serial self-collected cervicovaginal swabs obtained from Year 1 through Year 10, HPV testing using the TypeSeq2 assay, determination of persistent infection from repeated HPV-positive results, and longitudinal follow-up to capture first occurrence of infection with any vaccine HPV type.

Time frame: 1 to 10 years after first HPV vaccination

Secondary Outcomes

Vaccine efficacy against multiple cervical endpoints, anal HPV prevalence, immunogenicity, and histologic endpoints

Estimate the vaccine efficacy of 1 dose and 2 doses of Gardasil9 against 6 month cervicovaginal persistent infection related to HPV 6/11/16/18/31/33/45/52/58 by comparing vaccinated participants with an unvaccinated epidemiology survey cohort. Study measures include self-collected cervicovaginal samples obtained at the 9.5- and 10-year visits, HPV genotyping using the TypeSeq2 assay, identification of persistent infections present at both visits, and comparison of infection prevalence in vaccinated participants versus approximately 4,000 unvaccinated women enrolled in the Epidemiologic HPV Survey.

Data from ClinicalTrials.gov

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