Status: Planned First registered on: 02/08/2019
Last updated on: 02/08/2019
1. Study identification
EU PAS Register NumberEUPAS30769
Official titleHPV vaccines effectiveness to prevent genital warts in Valencia Region, Spain
Study title acronym
Study typeObservational study
Brief description of the studyGenital warts are a frequent sexually-transmitted disease. It has been estimated that about 5–10% of the population will have at least one episode of genital warts during their lifetime1. It has been recently described an overall annual incidence of genital warts from 160 to 289/100,000 person-years. Over 90% of genital warts are related to HPV6/11. In Europe there are three licensed vaccines containing recombinant HPV L1 capsid proteins. In the Valencian Community in Spain, the quadrivalent HPV vaccine (HPV 6/11/16/18) was used only between 2008 and 2010 and was administered in a three-dose regimen to vaccinate girls when they were 14 years old. Thereafter, the bivalent vaccine AS04-bHPV (HPV 16/18) was used. This change allowed us to perform the first analysis (to our knowledge) of the effectiveness of both HPV vaccines in preventing genital warts in the same population. In the previous population-based study the oldest vaccinated women in our cohort was 19 years old at the end of the follow up period, so we were unable to assess the vaccine impact on cervical cancer as these women did not reach the screening age. Unvaccinated girls and those vaccinated with the bivalent vaccine had the same risk of incidence of genital warts. HPV-related tumors in HIVpositive patients tend to occur at a younger age and at a more advanced stage than in HIV-negative patients. One of our objectives in the present study is to estimate the effectiveness of the HPV vaccines to prevent genital warts in women aged from 14 to 23+ (depending on the date of data extraction) years old. We also propose to assess the incidence and treatment-costs of GW in subjects aged from 14 to 65 years old. Another secondary objective is to estimate the effectiveness of the HPV vaccines to prevent genital warts in IC women aged from 14 to 23+ years old. Finally, towards future studies we aim to explore the precancerous lesions diagnoses in women aged from 14 to 65 years old.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFISABIO
Centre locationValencia
Details of (Primary) lead investigator
Title Dr
Last name Munoz-Quiles
First name Cintia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/10/2018
Start date of data collection05/11/2018
Start date of data analysis05/06/2019
Date of interim report, if expected
Date of final study report05/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMSD100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Munoz-Quiles
First name Cintia
Address line 1Avenida Cataluña 21
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain
Phone number (incl. country code)0034961925950 
Alternative phone number 
Fax number (incl. country code) 
Email address cinquiles@gmail.com
Public Enquiries
Title Dr 
Last name Munoz-Quiles 
First name Cintia 
Address line 1Avenida Cataluña 21 
Address line 2 
Address line 3 
CityValencia 
Postcode 
CountrySpain 
Phone number (incl. country code)0034961925950 
Alternative phone number 
Fax number (incl. country code) 
Email address cinquiles@gmail.com 
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