Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study
Long-Term Immunologic Follow-Up of Women Who Received One, Two, and Three Doses of the Bivalent HPV Vaccine in the Costa Rica HPV-16/18 Vaccine Trial (CVT): Generating Durability Data: The ESCUDDO-CVT Study
Sponsor: National Cancer Institute (NCI)
This observational or N/A phase trial investigates Human Papillomavirus Infection and Human Papillomavirus-Related Malignant Neoplasm and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 32 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.
SECONDARY OBJECTIVES:
I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.
II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.
III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.
OUTLINE: This is an observational study.
Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.
PRIMARY OBJECTIVES:
I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.
SECONDARY OBJECTIVES:
I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.
II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.
III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.
OUTLINE: This is an observational study.
Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.
Status Flow
Change History
32 versions recorded-
Apr 23, 2026 — Present [daily]
Active Not Recruiting
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Apr 21, 2026 — Apr 23, 2026 [daily]
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▶ Show 27 earlier versions
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Sep 2024 — Feb 2025 [monthly]
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Dec 2021 — Feb 2022 [monthly]
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Oct 2020 — Nov 2020 [monthly]
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Status: Terminated → Active Not Recruiting
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Jun 2020 — Oct 2020 [monthly]
Terminated
Status: Active Not Recruiting → Terminated
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May 2020 — Jun 2020 [monthly]
Active Not Recruiting
Status: Enrolling By Invitation → Active Not Recruiting
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Nov 2019 — May 2020 [monthly]
Enrolling By Invitation
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Oct 2019 — Nov 2019 [monthly]
Enrolling By Invitation
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Sep 2019 — Oct 2019 [monthly]
Enrolling By Invitation
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Nov 2018 — Sep 2019 [monthly]
Enrolling By Invitation
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Oct 2018 — Nov 2018 [monthly]
Enrolling By Invitation
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Sep 2018 — Oct 2018 [monthly]
Enrolling By Invitation
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Aug 2018 — Sep 2018 [monthly]
Enrolling By Invitation
Status: Not Yet Recruiting → Enrolling By Invitation
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Jul 2018 — Aug 2018 [monthly]
Not Yet Recruiting
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Jun 2018 — Jul 2018 [monthly]
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Apr 2018 — Jun 2018 [monthly]
Not Yet Recruiting
Phase: NA → None
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Oct 2017 — Apr 2018 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility Summary
This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .