Effect of HPV Vaccination on Women Aged 25 Years

November 19, 2014 updated by: Francesca Carozzi, Cancer Prevention and Research Institute, Italy

Effective Surveillance and Impact of HPV Vaccination on Screening for Cervical Cancer in Tuscany

The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old women at the time of their first access to cervical cancer screening, to understand the impact of vaccination on screening activity; to evaluate the immune response following vaccination; to study the dynamics of the infection after vaccination, including the possible change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities reductions in vaccinated women and to assess if HPV test in urine sample could be a useful non-invasive method to monitor HPV status in younger women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present trial, funded by Istituto Toscano Tumori, started in 2010 and was directed to all women aged 25 (birth cohorts 1985 and 1986), resident in the province of Florence and targeted by the screening program. After receiving approval from the Ethics Committee of the Local Health Unit of Florence, women were invited by invitation letter containing a clear description of the study. All women complying with the invitation were asked to fill in the informed consent document.

Women were randomized 1:2 in the Experimental Arm or in the Control Arm. At enrollment, women in the Experimental Arm, after collection of cervical samples (for Pap-test and HPV test), blood sample (for HPV antibody testing on serum before vaccination) and one first void urine sample (for HPV testing), received free vaccination with Cervarix® (vaccine against HPV 16 and 18, 3 doses scheduled). Women in the Control Arm received usual care, i.e. the collection of cervical sample for Pap test.

All women who signed the informed consent have been enrolled regardless of being sexually active or not. For virgo women cervical sample was not collected.

At the second round of screening (30 months since enrollment), women in both Arms were asked to collect cervical samples (for Pap-test and HPV test) while a new blood sample for HPV antibody testing was collected only in women enrolled in the Experimental Arm.

Women with normal cytology in Control Arm and women with HPV-negative result and normal cytology in Experimental Arm, received a recommendation by mail to repeat screening test after 3 years. Women with abnormal Pap test (Atypical Squamous Cells of Undetermined Significance or more severe, ASC-US+) were referred to immediate colposcopy at the Cancer Prevention and Research Insitute. Women with normal cytology and HPV positive were called after one year to repeat HPV test and Pap test. If HPV and Pap test were negative, women repeated both test after 30 months from enrolment. Otherwise if HPV test remained positive and/or cytology abnormalities were detected women were referred for colposcopy: if colposcopy didn't reveal high grade lesions (≤ CIN2) women repeated HPV and Pap test after 30 months from enrollment, if colposcopy revealed final histological diagnosis of CIN2+ lesions, women were recommended for an excisional treatment (both for study and control group).

The presence of high risk (HR) HPVs was evaluated by Hybrid Capture 2 (Qiagen, Gaithersburg, USA) using probe B for the detection of 12 high risk HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 (Group 1) and 1 "probably carcinogenic to humans" type HPV 68 (Group 2).

HPV genotyping was performed by INNO-LiPA Genotyping Extra that allows the identification of 28 different HPV types on L1 region on the HPV genome, it identifies all known HPV high-risk types (Group 1) 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59; "probably carcinogenic to humans" (Group 2A) HPV68; and all "possibly carcinogenic" HPV 26, 53, 66, 69, 70, 73, 82 (Group 2B) and "not classified as to its carcinogenicity to humans" (Group 3) (6, 11); and other HPV types: 40, 43, 44, 54, 71, 74.

HPV antibody testing was performed on an established and validated HPV serology method based on Luminex technology heparin coating of the beads and pseudovirions (PsVs) of 17 HPV types belonging to alpha species: 3, 6, 11, 16, 18, 31, 32 ,33, 35, 39, 45, 52, 56, 58, 59, 68, 73, and for four HPV types belonging to beta species: 5, 15, 38, 76.

Study Type

Interventional

Enrollment (Actual)

832

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50139
        • Cancer Prevention and Research Institute, ISPO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • resident in Florence
  • invited for the first time to the cervical cancer screening in Florence
  • aged 25 years

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no HPV vaccine
No delivery of HPV vaccine
Experimental: HPV vaccine (Cervarix®, GlaxoSmithKline)
Delivery of HPV vaccine (Cervarix®, GlaxoSmithKline) at 0, 1, 6 months
Biological: Cervarix®, GlaxoSmithKline
3 doses (0,1,6 months) of Cervarix®, GlaxoSmithKline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm
Time Frame: 30 months
30 months
number of cytological abnormalities in the Experimental arm and in No intervention arm
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects seropositive for HPV 16, 18, 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 at enrollment
Time Frame: enrollment
enrollment
Number of subjects seropositive for HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 after vaccination
Time Frame: 30 months
30 months
Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers before vaccination
Time Frame: at enrollment
Titers are given as Mean Fluorescence Intensity Unit (MFI)
at enrollment
Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers after vaccination
Time Frame: 30 months
Titers are given as Mean Fluorescence Intensity Unit (MFI)
30 months
Number of participants reporting Adverse Events
Time Frame: within 14 days following any injection
Adverse Events assessed include Local pain, Local swelling, Local pruritus, Local Erythema, Fever, and every adverse event reported day by day in a diary
within 14 days following any injection
HPV identification in urine samples
Time Frame: at enrollment
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Prevention and Research Institute, Italy

Collaborators

University of Florence
Istituto Toscano Tumori

Investigators

  • Principal Investigator: Francesca M Carozzi, PhD, Cancer Prevention and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F11J09000350002
  • 342/2009 (Other Identifier: Local Ethics Committee of Local Health Unit of Florence)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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