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Human Papillomavirus InfectionPhase 4ESCUDDO LTFUNCT07706673

ESCUDDO Long Term Follow Up

A Phase 4 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed and Recombinant Human Papillomavirus Nonavalent Vaccine in people with Human Papillomavirus Infection and Human Papillomavirus-Related Malignant Neoplasm, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed and Recombinant Human Papillomavirus Nonavalent Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,700 participants
Where
1 siteCosta Rica
Study dates
11 Aug 2026to 15 Jan 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Costa Rica1 site

  • Agencia Costarricense de Investigaciones Biomédicas (ACIB)

    Liberia, Guanacaste Province, 50101

Other trials in Costa Rica

About this study

Official 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)")

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Recombinant Human Papillomavirus Nonavalent Vaccine
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedBiological

    Also called Adacel, Daptacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed

    Given IM in ESCUDDO (NCT03180034)

  • Recombinant Human Papillomavirus Nonavalent VaccineBiological

    Also called Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

    Given intramuscularly (IM) in ESCUDDO (NCT03180034)

Study groups in NCT07706673
Study groupRoleWhat they receive
Arm I (Gardasil, Tdap)ExperimentalONE DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Receives: Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Arm II (2 Doses Gardasil)Active comparatorTWO DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Receives: Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Arm III (epidemiologic survey)No interventionUNVACCINATED: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 to 10 years after first HPV vaccination

  2. 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.

    Measured: 1 to 10 years after first HPV vaccination

Secondary outcomes (3)

  1. 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.

    Measured: 9.5 to 10 years after first HPV vaccination

  2. Comparison of high-grade cervical disease

    Estimate the incidence rate difference and relative risk of HPV 16/18/31/33/45/52/58-related high-grade cervical disease (CIN2 or worse) between recipients of 1 dose and 2 doses of Gardasil9. Study measures include HPV screening results from cervicovaginal swabs, referral to cytology and colposcopy through protocol-defined triage algorithms, collection of cervical biopsies and excisional specimens, pathology panel review, and HPV genotyping of tissue specimens to confirm HPV-associated CIN2, CIN3, adenocarcinoma in situ (AIS), or cervical cancer.

    Measured: 7 to 10 years after first HPV vaccination

  3. Long-term immunogenicity assessment

    Evaluate the peak and persistence of antibody responses (geometric mean concentrations and seropositivity rates) to all nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) following 1-dose and 2-dose vaccination regimens. Study measures include serum samples collected at enrollment and annual follow-up visits, laboratory assessment of HPV-specific antibody concentrations using the NCI IgG Luminex Immunoassay (LIA), calculation of geometric mean concentrations (GMCs), and determination of seropositivity rates for each vaccine HPV type. Additional annual blood collections in the Immunogenicity Subgroup (ISG) support detailed analyses of immune response durability. The ISG is a subset of approximately 700 Gardasil 9 participants (about 350 per dose arm) from ESCUDDO who consent to continue in the subgroup during LTFU.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start11 Aug 2026
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion15 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
13,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706673
Sponsor's protocol ID
NCI-2026-05053
Other IDs
NCI-2026-05053, CEC-HCB-E024-2026, V503-113, 26G002-02
Acronym
ESCUDDO LTFU
Status last verified
Aug 2026
First submitted
15 Jul 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed and Recombinant Human Papillomavirus Nonavalent Vaccine in people with Human Papillomavirus Infection and Human Papillomavirus-Related Malignant Neoplasm, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 7 to 10 years after first HPV vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07706673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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