HPV (Human Papillomavirus) Vaccine Studies

Women aged 18 to 26 yrs (HPV V505 Study) Oct 2007 to 2010

This study commenced in October 2007 and will run for 3 years. We are helping test a new vaccine called V505. V505 is made like Gardasil®, except that it may also offer protection against more types of HPV. This study will assess different strengths and doses of V505, for immune response and for side-effects, in comparison to Gardasil®.Consequently, 80% women participating in this study will receive V505 and 20% will receive Gardasil®.

STUDY STATUS: Recruitment Closed; Study Ongoing

Women aged 26 yrs and older (HPV 015 Study) 2006 to 2009

This study commenced in March 2006 and will run for 3 years. It is similar to the study for younger women, in that it is designed to evaluate the safety, immune response and effectiveness of the vaccine designed to provide protection against the HPV strains 16 and 18, but in women aged 26 years and above. The majority of subjects enrolled in previous HPV studies have been pre-teens, adolescents and young adults. The main aim of the study is to look at how effective the vaccine “Cervarix” is in preventing persistent infections of HPV types 16 and 18 in adult women.

STUDY STATUS: Recruitment Closed; Study Ongoing

Young women aged 17-25 years (HPV 008 Cervarix Vaccine Study) 2004 to 2008

This study commenced in August 2004 and will run for four years. Over 18,000 young women are enrolled in the study worldwide, with 145 enrolled through the VTG. Recruitment is closed. The study is investigating the safety and effectiveness of the vaccine “Cervarix” in producing an immune response against HPV types 16 and 18 and in preventing a persistent (longer than 6 months) infection with these HPV types. Study participants were randomised to receive either Cervarix or the “control” vaccine, a licensed Hepatitis A vaccine. Women in the study have six-monthly testing by cervical smears and annual blood tests. Any detected abnormalities are treated promptly according to national cervical screening guidelines.

>> Click here for interim results

STUDY STATUS: Recruitment Closed; Study Ongoing

Girls aged 10 to14 years (2004 to 2005)

This study commenced in July 2004 and is now complete. We are preparing our results for reporting. Two thousand girls were enrolled worldwide, 66 at VTG in Perth. The study was investigating the safety and efficacy of Cervarix in this age group. At some sites, but not at VTG, girls had blood tests to determine antibody production after vaccination.

We have contacted participants and their parents to inform them which vaccine they received in the study. Those girls who received Cervarix have been offered the Hepatitis A vaccination. Cervarix was licensed for use in May 2007 and we can now offer the vaccine to participants in the study who received the “control” Hepatitis A vaccine. These girls may choose instead to be immunised through their schools with the HPV vaccine Gardasil.

STUDY STATUS: Completed.

Merck Sharp & Dohme Gardasil HPV Study for adolescents and young women (2003 to 2004)

This study evaluated the immune response and safety of three doses of the Human Papilloma Virus vaccine Gardasil, and determined the minimum dose of the vaccine that provides protection against the virus. The study vaccine provided protection against four types of HPV - types 16 and 18 which are associated with cervical cancer and HPV types 6 and 11 that cause genital warts.

As all participants received the HPV vaccine, any further doses will not be needed now that this HPV vaccine is on the Australian immunisaton schedule for females aged 10 to 26 years of age. It is not yet known how long the protection will last and whether booster doses are needed, or exactly how well it prevents cervical cancer and genital warts caused by other HPV strains. As this is still being researched we will inform participants when results become available. Results in 2007 show that protection last at least five years.

>> Click here for study results

STUDY STATUS: Completed.