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Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the CVT Trial, ESCUDDO-CVT Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309033
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
The goal of this study is to extend 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 15 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.

Condition or disease Intervention/treatment
Human Papillomavirus Infection Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. Estimate the change in antibody levels between years 10 and 15. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15.

OUTLINE:

Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels at years 13 and 15 after receiving initial vaccination.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fifteen Years of 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
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
Observational (questionnaire, biospecimen collection)
Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels at years 13 and 15 after receiving initial vaccination.
Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Complete questionnaire




Primary Outcome Measures :
  1. Seropositivity [ Time Frame: Up to 15 years after initial vaccination ]
    Negative/positive status will be assessed using the standard predefined cutoffs established at the testing laboratory. Heterogeneity across the women under study will be assessed and reported.

  2. Change in antibody levels [ Time Frame: Between years 10 and 15 after initial vaccination ]
    Changes in the level of antibodies and geometric mean titers will be assessed. Heterogeneity across the women under study will be assessed and reported. For each individual, will measure the average change in human papillomavirus (HPV)16 (and HPV18) antibody levels between years 10 and 15. For each individual, will obtain this estimate by regressing log (titer) of the antibody levels on time. Will then calculate the mean and 95% confidence interval of this regression coefficient for each dose regimen (i.e., 1, 2, and 3 doses separately). Will also report 95% confidence intervals for these estimates.

  3. Proportion of individuals who serorevert [ Time Frame: Up to 15 years after initial vaccination ]
    For each dose regimen, will estimate the proportion of individuals who become antibody negative by the assay cutoff. Will also report 95% confidence intervals for these estimates.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine
Criteria

Inclusion Criteria:

  • Participation in the CVT Long Term Follow-Up (LTFU) study

Exclusion Criteria:

  • A random subset of the three-dose women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309033


Locations
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Costa Rica
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste, Costa Rica
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aimee R Kreimer National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03309033    
Other Study ID Numbers: NCI-2020-07430
NCI-2020-07430 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
999917173
17-C-N173 ( Other Identifier: National Cancer Institute )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections