HPV vaccines effectiveness to prevent genital warts in Valencia Region, Spain

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30770
• EU PAS number:
  EUPAS30769
• Study ID:
  30770
• Official title and acronym:
  HPV vaccines effectiveness to prevent genital warts in Valencia Region, Spain
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Genital 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Study timelines

Date when funding contract was signed

Actual: 05/10/2018

Study start date

Actual: 05/11/2018

Data analysis start date

Actual: 05/06/2019

Date of final study report

Planned: 05/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD

Study protocol

Initial protocol

AIV - FISABIO_HPV_2018_07_VEGW_CMQ_version1

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable