Elmar Joura (Austria)
Medical University Vienna Gynecologic OncologyPresenter of 2 Presentations
HPV VACCINATION PROTECTS AGAINST HPV INFECTION AND DISEASE IN SEXUALLY ACTIVE ADULTS: A REVIEW OF QUADRIVALENT HPV VACCINE CLINICAL TRIALS (ID 1302)
Abstract
Introduction
The quadrivalent HPV (qHPV) vaccine clinical program included sexually active females regardless of baseline HPV status. Therefore, per-protocol efficacy analyses for each vaccine HPV type (HPV6/11/16/18) included participants infected by other vaccine or non-vaccine HPV types. The qHPV vaccine demonstrated consistently high clinical efficacy in females aged 16–45 years. The vaccine is prophylactic, without efficacy against disease caused by HPV types present before vaccination.
Methods
We summarize data from the randomized, placebo-controlled, double-blind, international FUTURE I (NCT00092521), II (NCT00092534), and III (NCT00090220) qHPV vaccine studies in females aged 16–26 (N=17,622; FUTURE I and II) and 24–45 years (N=3819; FUTURE III). HPV DNA positivity was a surrogate for current infection; anti-HPV seropositivity and HPV DNA negativity was a surrogate for past infection.
Results
Clinical trial data indicate that infection with all vaccine HPV types is rare: 0.1% of 3578 North American females were positive for all four qHPV vaccine types by serology and/or HPV DNA; none were infected with all 9-valent HPV vaccine types. Most prevalent HPV infections in females aged 16–25 years consist of only one or two high-risk HPV types (Barr, Am J Obstet Gynecol 2008). In FUTURE I and II participants infected with 1–3 vaccine HPV types, the qHPV vaccine protected against HPV-related cervical and external genital disease caused by the remaining HPV types (FUTURE II Study Group, J Infect Dis 2007). The qHPV vaccine also prevented cervical and external genital disease in females aged 16–26 years and persistent infection in females 27–45 years regardless of previous exposure to vaccine HPV types (Olsson, Human Vaccines 2009; Castellsague, Br J Cancer 2011).
Conclusions
HPV vaccination can protect against HPV infection and disease in adults previously infected with HPV. Vaccination should not be withheld from sexually active individuals with prior HPV exposure.
IMMUNOGENICITY AND SAFETY OF A NINE-VALENT HUMAN PAPILLOMAVIRUS VACCINE IN WOMEN AGED 27–45 YEARS VERSUS 16–26 YEARS: AN OPEN-LABEL PHASE 3 TRIAL (ID 1306)
- Elmar Joura (Austria)
- Corinne Vandermeulen (Belgium)
- Klaus Peters (Germany)
- Antonino Perino (Italy)
- Angels Ulied (Spain)
- Ilkka Seppä (Finland)
- Veronika Jotterand (United States of America)
- Kyeongmi Cheon (United States of America)
- Sonali Rawat (United States of America)
- Alain Luxembourg (United States of America)
- Frederick Wittke (Switzerland)