ESCUDDO Long Term Follow Up

NCT07706673 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 4 other identifiers: NCI-2026-05053CEC-HCB-E024-2026V503-11326G002-02
• Study Type: interventional
• Target: 13,700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papillomavirus Infection; Human Papillomavirus-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 to 10 years after first HPV vaccination

Secondary Outcomes (3)

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

  9.5 to 10 years after first HPV vaccination

• Comparison of high-grade cervical disease

  7 to 10 years after first HPV vaccination

• Long-term immunogenicity assessment

  Up to 10 years after vaccination, with measurements during LTFU annual visits

Study Arms (3)

Arm I (Gardasil, Tdap)

EXPERIMENTAL

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

Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm II (2 Doses Gardasil)

ACTIVE COMPARATOR

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

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Arm III (epidemiologic survey)

NO INTERVENTION

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).

Interventions

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed BIOLOGICAL

Given IM in ESCUDDO (NCT03180034)

Also known as: Adacel, Daptacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine, DTaP, Infanrix, Tripedia

Arm I (Gardasil, Tdap)

Recombinant Human Papillomavirus Nonavalent Vaccine BIOLOGICAL

Given intramuscularly (IM) in ESCUDDO (NCT03180034)

Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Arm I (Gardasil, Tdap); Arm II (2 Doses Gardasil)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Merck Sharp and Dohme LLC: collaborator

Study Sites (1)

Agencia Costarricense de Investigaciones Biomédicas (ACIB)

Liberia, Guanacaste Province, 50101, Costa Rica

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Diphtheria Toxoid; adacel; Diphtheria-Tetanus-acellular Pertussis Vaccines; Tetanus Toxoid; Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Aimee Kreimer

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Specimen lab
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 16, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): January 15, 2031
• Last Updated: September 22, 2026

Record last verified: 2026-08

Locations

CO (1)