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Fifteen-year 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

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ClinicalTrials.gov Identifier: NCT03309033
Recruitment Status : Terminated (NIH is not engaged in human subjects research)
First Posted : October 13, 2017
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date October 12, 2017
First Posted Date October 13, 2017
Last Update Posted Date May 15, 2020
Actual Study Start Date July 18, 2018
Actual Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2018)
  • Estimate the change in antibody levels between years 10 and 15 foreach dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up). ]
    Estimate the change in antibody levels between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18).
  • Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up) ]
    Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18).
Original Primary Outcome Measures
 (submitted: October 12, 2017)
  • Estimate the change in antibody levels between years 10 and 15 foreach dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up). ]
  • Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 10 and 15 for each dose regimen (i.e. 1-dose, 2-doses, 3-doses) and each HPV type (i.e. 16, 18). [ Time Frame: Year 5 of EXTEND (Year 15 of CVT follow-up) ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fifteen-year 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
Official Title Fifteen-year 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
Brief Summary

Background:

HPV is the human papillomavirus. Women who get infected with it can get cervical cancer. The Costa Rica vaccine trial (CVT) studied an HPV vaccine for young women. A Long Term Follow Up (LTFU) study was done 10 years later. Researchers want to follow up with the women in these studies for 5 more years. This will help them learn more about the risks and benefits of the HPV vaccine.

Objectives:

To study anti-HPV-16/18 antibodies over the long term in women who got an HPV vaccinate. To study how antibody levels have changed depending on the dose and type of vaccine.

Eligibility:

Women in the original CVT LTFU study

Design:

Staff will contact participants from the CVT LTFU study. This will be done by phone or in person at home. Participants will be asked about participating in a new study.

Participants who agree will have their first study visit and sign the informed consent document.

Participants will answer questions about sexual behavior, smoking, contraceptives, and reproductive history.

Participants will have blood collected.

Study visits will be conducted either in a clinic or at home.

Detailed Description

Human papillomavirus (HPV) infection is necessary for the development of cervical cancer. Worldwide, infection with HPV types 16 and 18 account for approximately 70% of cervical cancer cases. Currently available data suggest that prophylactic vaccination against HPV types-16 and 18 is nearly 100% effective in preventing persistent cervical infections and resultant disease from these types for at least five years following vaccination. The U.S. National Cancer Institute (NCI) and the ACIB (formerly PEG) conducted a community-based, randomized clinical trial (RCT) in Costa Rica (called the Costa Rica Vaccine Trial, CVT) pre-licensure to evaluate the VLP-based, bivalent HPV vaccine. One of the more unexpected and novel discoveries showed that, in a post-hoc analysis, protection over four years against HPV16/18 infections among women initially uninfected with these types was uniformly high for recipients of one, two, or three doses after four years of follow-up in the blinded phase of the CVT. Among women who received a single dose, HPV16 and HPV18 antibody titers (assessed by ELISA) were substantially higher than those among unvaccinated women previously exposed to HPV16/18; titers remained stably elevated from 6-to-48 months post-vaccination, albeit at lower levels than for two or three doses. These and other data have motivated a new undertaking to directly evaluate the protection afforded by single-dose regimens of the HPV vaccines in a formal RCT. Complementary to the non-inferiority data that will be generated over 4 years in this new RCT, it is imperative that we continue to evaluate long-term stability of antibody responses. To do so, the current proposal aims to extend the follow-up time of women in the original CVT who received one or two doses and a subset who received three doses of the HPV vaccine from 10 to 15 years (two additional visits from ~1000 women at years 13 and 15, respectively) to describe, by dose, the long-term positivity and stability of the antibody response to HPV vaccination. There are two main objectives to this work:

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

This research will provide invaluable data that will allow for the continued investigation into the risks and benefits of the prophylactic HPV vaccine; also, new serologic testing of banked samples from the original phases of this research will be conducted to merge data from years 1 and 10 with years 13 and 15 to provide a complete assessment of antibody changes over time. Additional immunologic assays will be conducted, including assessment of antibody avidity, between years 10 and 15.

The CVT EXTEND study will be conducted by the ACIB team, which has extensive experience in conducting epidemiological and clinical studies with high ethical and scientific standards. These studies have high rates of recruitment and retention.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ~1000 women from the original CVT and LTFU, including all who received one or two doses, and a subset of those who received three doses of the HPV vaccine.
Condition
  • Human Papillomavirus
  • Cervical Cancer
Intervention Not Provided
Study Groups/Cohorts Group 1
-Women aged 30-38 who participated in the CVT LTFU study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 5, 2019)
869
Original Estimated Enrollment
 (submitted: October 12, 2017)
1000
Actual Study Completion Date May 13, 2020
Actual Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • Women aged 30-38 who participated in the CVT LTFU study.

EXCLUSION CRITERIA:

-This study will exclude a random subset of the three-dose women. This exclusion is due to the following scientific considerations:

  • Other global investigations are following three-dose HPV vaccine recipients from the initial trials, and these investigations will yield adequate information in advance of our study
  • For immunological outcomes, we are well powered, and only need information from a subset.
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 38 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Costa Rica
Removed Location Countries  
 
Administrative Information
NCT Number NCT03309033
Other Study ID Numbers 999917173
17-C-N173
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Aimee R. Kreimer, Ph.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 2020