An observational study in Human Papillomavirus Infection and Human Papillomavirus-Related Malignant Neoplasm, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1 site in Costa Rica. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Cancer Institute (NCI) · Observational
Among 20 studies in Papillomavirus Infections by National Cancer Institute (NCI) — 3 open to participants now, 11 under way, none of them phase 3. Papillomavirus Infections · National Cancer Institute (NCI).
Among the 20 studies in Papillomavirus Infections by National Cancer Institute (NCI), this one is the only one that started in 2018, is one of 3 observational ones, reaches primary completion later than 2 of the 10 other live ones, and was the 10th registered.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
Browse Papillomavirus Infections studies →3 of the 20 studies in Papillomavirus Infections by National Cancer Institute (NCI) are open now, in 2 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 25+ · Women only · Healthy volunteers
National Cancer Institute (NCI) · Sites in Costa Rica
Ages 18+ · Women only · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
By country, each count listing its studies:
Of the 85 Papillomavirus Infections studies recruiting now, 38 (45%) set no upper age limit and 42 (49%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 4 2
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 486 across 157 observational studies indexed under Papillomavirus Infections.
Median enrollment 84 across the 17 interventional studies, 5,444 across the 3 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
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National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
6 of the studies in Papillomavirus Infections by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00867464National Cancer Institute (NCI)Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls | 2026-12-23 |
| NCT06611540National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03) | 2026-12-30 |
| NCT06611553National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02) | 2026-12-30 |
| NCT06498661National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01) | 2026-12-30 |
| NCT07281430National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04) | 2026-12-30 |
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Among the 20 studies in Papillomavirus Infections by National Cancer Institute (NCI), from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Biospecimen Collection · Other: Questionnaire Administration
Undergo collection of blood samples
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Complete questionnaire
Seropositivity
Negative/positive status will be assessed using the standard predefined cutoffs established at the testing laboratory.
Time frame: Up to 20 years after initial vaccination
Change in antibody levels
Will report the geometric mean titer levels and their 95% confidence intervals at years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20 for the 1-dose, 2-dose and 3-dose groups and for both human papillomavirus (HPV)-16 and HPV-18 antibodies. Will estimate these quantities using a weighted linear mixed models with log-titer level as the dependent variable and year as the independent variable, adjusting for laboratory batch and including a random-effects for participant and, when needed, participant: study year. For the three-dose analysis, will also include a covariate for study group. Moreover, will model the 19-year trend (e.g. excluding peak titers at year 1) by including time as a single continuous variable (i.e. linear effect) and then model time flexibly using a natural spline to assess a potentially non-linear relationship.
Time frame: Between years 11 and 20 after initial vaccination
Proportion of individuals who serorevert
For each dose regimen and for HPV 16, HPV 18, and a composite endpoint of either HPV type, will estimate the proportion of individuals who serorevert (i.e., become antibody negative by the assay cutoff) in years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20. Will also report 95% confidence intervals for these estimates. Again, will follow the approach described in our previous work. Note, will consider both standard and updated cutoffs and will use batch-adjusted levels. Can obtain the relative risk for seroreversion and its 95% confidence interval using score tests. Will then use generalized linear mixed models with seroreversion as the outcome and all other parameters similar to above to assess trends over time.
Time frame: Between years 11 and 20 after initial vaccination
Ran from Jul 2018 to primary completion in Mar 2026, 92 months.
Of 53 non-industry observational studies under Papillomavirus Infections, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 92. This study's 92 months is above that.
Counting every sponsor, half of 66 studies reached it within 46 months; a quarter within 24 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI) →