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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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT03309033
Collaborator
(none)
900
Enrollment
1
Location
54
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jul 2, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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 Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Complete questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Seropositivity [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Participation in the CVT Long Term Follow-Up (LTFU) study
    Exclusion Criteria:
    • A random subset of the three-dose women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Agencia Costarricense de Investigaciones Biomédicas (ACIB) Liberia Guanacaste Costa Rica 50101

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Aimee R Kreimer, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT03309033
    Other Study ID Numbers:
    • NCI-2020-07430
    • NCI-2020-07430
    • 999917173
    • 17-C-N173
    First Posted:
    Oct 13, 2017
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Papillomavirus Infections

    Study Results

    No Results Posted as of Aug 12, 2022